Skin

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View Article by Nick Waddell on Cantech Letter click here (1/11/2017)

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Japan’s Pharmaceuticals and Medical Devices Agency reviews RepliCel’s pre-clinical, quality, and manufacturing data for its non-bulbar dermal sheath (NBDS) platform

VANCOUVER, BC – April 25, 2016 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP) (Frankfurt: P6P1), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced that it met this month with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in Tokyo. The meeting was a formal consultation review of the company’s pre-clinical, quality, and manufacturing data related to its non-bulbar dermal sheath (NBDS) platform technology. This review is a required step in the process to obtain PMDA consent to perform a clinical trial in Japan.

“We have been very encouraged by the PMDA’s collaborative approach and yet the absolute high standards of safety they maintain”, stated R. Lee Buckler, President & CEO, RepliCel Life Sciences Inc. “The conduct of this consultation meeting moves the clinical-stage products (RCT-01 tendon repair; RCS-01 skin rejuvenation) being developed from our NBDS platform closer to the launch of Japanese clinical trials and partnerships”, he added.

Furthermore, each consultation performed by the PMDA at the formal request of a potential clinical trial sponsor, carries with it associated fees which are lowered for academic institutions, hospitals, and small/medium enterprises. Additionally all documentation created for the consultation must be provided in Japanese.

Without any known precedent for doing so, RepliCel, on the advice of CJ Partners Inc., applied for the reduced-fee designation based on its small size and the pre-revenue nature of its business. The company was successfully awarded a reduced fee status which represents approximately one-tenth of the otherwise applicable fees.

“To the extent that CJ Partners knows, this is the first time that a foreign regenerative medicine company has qualified for the reduced price status with the PMDA”, commented Colin Lee Novick, Managing Director of CJ Partners Inc.

“RepliCel continues to pioneer foreign participation in cell therapy development in Japan”, said Buckler. “We are committed to early commercialization of our products in Japan and entering into a Japanese-based partnership for each product in our cell therapy portfolio.”

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal healing and function. The Company’s product pipeline is comprised of two ongoing clinical trials (RCT-01: tendon repair and RCS-01: skin rejuvenation) as well as its RCH-01: hair restoration product under exclusive license by Shiseido Company for certain Asian countries.

All product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles. The Company has also developed a proprietary injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications. Please visit www.replicel.com for additional information.

For more information, please contact:

CORPORATE:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com

MEDIA/INVESTOR RELATIONS:
Jacqui Specogna
Telephone: 604-248-8730 / js@replicel.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

Certain statements in this press release related to the Program are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events, and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “will”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Such statements are qualified in their entirety by the inherent risks and uncertainties surrounding the number of Warrant Holders that may participate in the Program, the use of proceeds and final regulatory approval. Such forward-looking statements should therefore be construed in light of such factors, and the Company is not under any obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Results from both trials will support commercialization initiatives, partner discussions and continued clinical development

VANCOUVER, BC – April 20, 2016 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP) (Frankfurt: P6P1), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced today that it has enrolled its final patients for both its RCT-01 and RCS-01 clinical trials. This ensures clinical data for both trials will be analyzed and released near year-end. Positive safety data will allow the company to move forward with phase 2 trials for both products in 2017. Data pertaining to the products’ effects post-injection will inform and guide the company’s product development and clinical trial strategy for both tendon repair and skin rejuvenation applications.

RCS-01: Skin Rejuvenation

RCS-01 is a proprietary cell-therapy product comprised of non-bulbar dermal sheath (NBDS) which are type 1 collagen-expressing fibroblasts derived from the hair follicle. The phase 1, single-centre trial currently ongoing in Dusseldorf, Germany, is investigating injections of RCS-01 as a treatment for UV-damaged and aged skin. The trial had projected enrollment at 30 participants; 15 male and 15 female. While the female cohort of the trial has been completely enrolled, the slow pace of male enrolment combined with an anticipation that this product will be largely targeted for female consumers, led to the decision to finish enrolment at the 17 participants already enrolled. The complete data set of the female cohort will permit study analysis for this subset of subjects as originally planned.

RCT-01: Tendon Repair

RCT-01 is a proprietary cell-therapy product comprised of non-bulbar dermal sheath (NBDS) which are type 1 collagen-expressing fibroblasts derived from the hair follicle. The phase 1/2, single-centre trial currently ongoing in Vancouver, British Columbia, is investigating the use of RCT-01 as a treatment for chronically injured ankle (Achilles) tendons otherwise called Achilles tendinopathy or tendinosis. The original targets for this trial were 28 participants to be injected by the end of Q1 2016 such that data would be available from this trial near year-end 2016. In order to ensure data near year-end 2016, the company decided to complete enrolment at the 10 patients currently enrolled.

“We have adjusted our plans for the RCT-01 clinical trial in part because it started later in 2015 and enrolled slower than originally anticipated. While the trial did not meet projected enrolment targets, we are confident the safety and preliminary efficacy data obtained by year-end will provide a signal of the product’s potential to regenerate chronically injured tendon that has failed to respond to other treatments. This will allow our teams to effectively plan larger phase 2 trials in 2017 which are powered to be statistically significant for clinical efficacy (evidence the product works as intended)”, stated Vice-President of Clinical Affairs, Darrell Panich.

“Future trials involving products from our non-bulbar dermal sheath (NBDS) platform will be designed to investigate the efficacy of these products at different dose levels and treatment frequencies while continuing to collect other data that will be used to support eventual RCS-01 and RCT-01 marketing applications by our commercial partners.”

“The delivery of clinical data when promised is important to management”, said R. Lee Buckler, President & CEO, RepliCel Life Sciences Inc. “We have made critical decisions to keep our commitment to the financial community and we believe the data from these trials will facilitate us closing a licensing and co-development deal on one or both of these products similar to the kind we have in place with Shiseido Company for our RCH-01 product”, he added.

About RepliCel’s NBDS Fibroblast Platform

RepliCel’s NBDS fibroblast platform has the potential to address numerous indications where impaired tissue healing has been stalled due to a deficit of active fibroblast cells required for tissue remodeling and repair. RepliCel’s proprietary NBDS fibroblast cells, isolated from healthy hair follicles, are a rich source of fibroblasts unique in their high-level expression of the necessary proteins, such as Type I collagen, required to jump-start the stalled healing cycle. The company is developing a series of products from this platform that have the potential to address large commercial markets in the areas of musculoskeletal and skin-related conditions. To learn more about RepliCel’s RCT-01 treatment for chronic tendinosis please watch our video: www.youtube.com/watch?t=23&v=kaa0hiJyeV4

About RepliCel Life Sciences

For more information, please contact:

CORPORATE:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com

MEDIA/INVESTOR RELATIONS:
Jacqui Specogna
Telephone: 604-248-8730 / js@replicel.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

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Phase 1 clinical trial investigating the use of a patient-specific cell-based dermal rejuvenation product (RCS-01) is scheduled to deliver data in late 2016

VANCOUVER, BC – December 17, 2015 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, today announced that the first injections of study products have been completed in the phase 1 clinical study (NCT02391935) evaluating RCS-01, an autologous cell-based skin rejuvenation product. RepliCel is developing RCS-01 as a longer-lasting, more natural alternative to existing dermal fillers on the market which often have only short-term results.

RepliCel’s RCS-01 cell therapy uses a participant’s own replicated fibroblast cells, isolated from their hair follicles, to rebuild the collagen, elastin and other glycoproteins that provide structural support and stability to the skin’s extracellular matrix – intended to return skin back to its youthful appearance.

The single-centre study, being conducted in Germany, will evaluate the safety and tolerability of injecting RCS-01 into adult patients with aged and wrinkled skin.

“I am very pleased with the speed and efficiency with which the Düsseldorf team has been able to recruit participants for our RCS-01 trial,” commented Darrell Panich, Vice President of Clinical Affairs. “Their efforts have allowed us to complete the first injections this week and have over half of the study compliment provide biopsies before the end of 2015. This will allow for study products to be manufactured during the Christmas break and for more injections to take place in the New Year. With their continued diligence, we anticipate a conclusion of the recruitment phase of the trial in early 2016.”

Dr. Rolf Hoffmann, RepliCel’s Chief Medical Officer, added: “The treatment of our first participants in this trial is a significant step in the clinical development of RCS-01 as we explore the product’s ability to restore the dermal matrix of the skin. We believe RCS-01 represents a potential game changer in the treatment of wrinkles and aged skin, and may provide a viable minimally-invasive alternative to dermal fillers which have varying results and are not sustainable for long periods of time.”

Trial Design
The study is projected to include 30 volunteer participants selected based on their health status, current/past medications and ability to adhere to protocol-related requirements. After providing informed consent, participants will be evaluated against the study inclusion/exclusion criteria and will provide blood samples for screening assessments. If selected for participation, four treatment evaluation sites will be identified on the buttocks – two on each side and a biopsy will be taken from the scalp from which RCS-01 will be prepared. Participants will be randomized into one of two treatment groups; one will receive injections of RCS-01, placebo and a ‘sham’ injection (a needle penetration without injection of liquid) while the other (placebo) group will only receive placebo and ‘sham’ injections. The primary purpose of this study is to assess the safety profile of RCS-01 injections. The study will also measure the impact RCS-01 injections have on skin markers related to aging through evaluation of gene expression profiles. The data collected from this trial will provide crucial information on the safety of injections RCS-01 and will provide a glimpse into how the product may improve the skin’s appearance in areas of aesthetic importance. This data will also support the design of future clinical trials that will further evaluate the efficacy of RCS-01 in the treatment of UV-damaged/aged skin. For more details on the clinical trial click here.

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal healing and function. The company’s product pipeline is comprised of two ongoing clinical trials (RCT-01: tendon repair and RCS-01: skin rejuvenation) as well as its RCH-01: hair restoration product under exclusive license by Shiseido Company for certain Asian countries. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s healthy hair follicles. The company has also developed a propriety injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications. Visit www.replicel.com for additional information.

For more information, please contact:

CORPORATE/MEDIA:
Tammey George, Director of Communications
Telephone: 604-248-8696 / tg@replicel.com

INVESTOR RELATIONS:
Lee Buckler, VP Business & Corporate Development
Telephone: 604-248-8693 / lee@replicel.com

This press release contains forward-looking information that involve various risks and uncertainties regarding future events, including statements regarding our approach and our technology, expected and planned upcoming milestones and events, and the timing of trials. Such forward-looking information can include without limitation statements based on current expectations involving a number of risks and uncertainties and are not guarantees of future performance of RepliCel. There are numerous risks and uncertainties that could cause actual results and RepliCel’s plans and objectives to differ materially from those expressed in the forward-looking information, including: delays enrolling clinical trial participants; negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Actual results and future events could differ materially from those anticipated in such information. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, RepliCel does not intend to update these forward-looking statements.

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Canadian companies driving global breakthroughs in regenerative medicine

By Kathryn Boothby

To read this article on the Financial Post website, click here.
CCRM – helping position Canadian companies at the centre of regenerative medicine around the world

Rapid advances in regenerative medicine are bringing the promise of curative solutions for chronic conditions closer to reality. Canadian companies are at the forefront of this revolution, paving the way for this country to be a standard-bearer of breakthrough treatments for patients around the globe.

Therapies using cells are potentially improving outcomes and reducing or eliminating side effects for such devastating diseases as diabetes, hemophilia, and critical limb ischemia, as well as conditions such as chronic tendinosis, damaged skin, and pattern baldness. New tools and technologies are also helping to put an end to bulky, obtrusive mechanisms to deliver life-saving treatments.

“We are at a powerful leading edge for medicine,” says Michael May, president and chief executive officer of the Centre for Commercialization of Regenerative Medicine (CCRM) in Toronto. “The ability to regenerate tissue will transform the treatment of diseases, quality of life, and the economics of health care.”

“Billions are being spent globally in the field of regenerative medicine on investment, research, development and sales,” says May. “Now, with clinical efficacy being demonstrated, we’re seeing more regulatory approvals and resulting mega-deals between small companies and large corporations.”

But where does Canada fit in the global picture? The discovery of stem cells in Canada in the 1960s sparked the worldwide use of bone marrow transplants for patients with leukemia and aplastic anemia. “This spawned an incredible research machine that made some important discoveries over the ensuing years. We are at a similar junction today,” he says. “We’re leading the science and have begun to leverage commercialization around the globe. The system is primed; we now need to fuel it with private investment to ensure Canada is at the centre of this emerging industry.”

CCRM is actively working to achieve that goal by coordinating access to bundles of technologies from around the globe; creating and supporting companies to further develop and commercialize those discoveries; and establishing relevant industry networks and accessible infrastructure. CCRM currently works with a 50-member industry consortium that includes therapeutic innovation companies, multinational pharmaceutical organizations such as Pfizer and Amgen, and infrastructure and tool companies such as GE Healthcare and Stemcell Technologies.

“Access to strong academic and industry networks enables us to now build a third key stakeholder group —an investor network,” says May.

That strategy is beginning to pay off for some of Canada’s cell therapy companies, including RepliCel Life Sciences Inc., Hemostemix Inc., and Sernova Corp.

RepliCel (TSX.V: RP) is driving multiple products in the regenerative medicine arena with three cell therapy products in clinical development, and a dermal injection device that promises to change the way any product is delivered in or under the skin, including the over $2-billion worth of dermal fillers injected annually.

“2015 is a pivotal year for the company,” says Lee Buckler, RepliCel’s vice-president, business and corporate development. “This is the year we moved all our cell therapy assets forward in clinical development, which sets us up for transformative catalysts over the next 18 months.” Earlier this year, RepliCel launched a Canadian trial for chronic tendinosis and just recently announced the launch of a dermatology trial in Germany. Topping off the trio is a trial for pattern baldness with commercialization partner Shiseido Company, which is expected to launch in Japan shortly.

RepliCel is one of a handful of foreign cell therapy companies with an active partnership in Japan. “Having Shiseido, one of the world’s largest cosmetic firms, as RepliCel’s partner for its pattern baldness product, has given us notable credibility in that market,” says Buckler, “and we are now engaging other companies in Japan about partnerships for our other products.”

“Partnering in Japan is at the top of our list because the government has expedited the process of developing cell-based therapies, making it possible to bring cell therapies to market faster there than any other regulated market in the world,” says Buckler.

Hemostemix (TSX.V: HEM) is currently undertaking an international phase-two, double-blind, randomized, placebo-controlled clinical trial to test the efficacy of a cell therapy to treat critical limb ischemia (CLI). CLI is characterized by insufficient blood flow to the lower limbs caused by blockages in small blood vessels. In North America alone, some four million people have the disease, and 25% will die from it. Currently, the only treatment is amputation.

The process involves collecting cells from a patient’s blood that are then manufactured into a cell therapy and delivered back to the patient. The company believes that the reintroduced cells create new blood vessels that restore blood flow and save the limb from amputation.

“CLI is a severe disease, threatening millions of people’s lives worldwide. We are running our clinical trials in leading international centers, including Canada, the U.S., South Africa, and soon in Taiwan,” says Dr. Elmar Burchardt, Hemostemix’ president and chief executive officer and former vice-president of regenerative medicine at Pfizer.

Sernova (TSX.V: SVA), a clinical stage company, is treating chronic, debilitating diseases such as insulin-dependent diabetes, hemophilia A and thyroid disease using a regenerative medicine approach through the placement of immune-protected therapeutic cells into an implanted pre-vascularized medical device. The company believes that the Cell Pouch System, about the size of a business card, creates a natural organ-like environment when placed under the skin and the cells release required proteins or hormones such as insulin, or Factor VIII potentially eliminating the need for chronic injections or infusions.

For diabetes, Sernova’s product — the device and cells implanted in humans — is being designed to mimic the pancreas where cells (islets) read blood sugar levels then release both insulin and other hormones into the bloodstream. The company has recently become a fully integrated pharmaceutical company as it has gained worldwide exclusive rights to a glucose responsive insulin-producing stem cell technology from University Health Network (UHN). The company has received grants from the National Research Council, Juvenile Diabetes Association and support from both the Canadian and Ontario governments to assist with its activities.

“If Sernova’s treatment leads to patients no longer having to take injections or deal with a cumbersome device, this could improve the quality of life for millions of people, reduce the debilitating side-effects of the disease, and cut health care system costs significantly,” says Dr. Philip Toleikis, Sernova’s president and chief executive officer.

“Canada imports close to 100% of our medical treatments,” notes May. “It would be much more exciting to be exporting our treatments and using our health care system to develop and deliver those products to patients around the world, all while improving the health of Canadians here at home.”

Canadian companies working in regenerative cell therapy have globally competitive technologies and great science. RepliCel, Hemostemix, and Sernova are all moving products through clinical trials at a time when big industry players are making investments in manufacturing, therapeutics and tools to facilitate the production of cells.

“While every company’s corporate strategy is different,” concludes RepliCel’s Buckler, “it is our corporate intention to build sufficient value in our assets, licenses, and royalty streams so that the company becomes a home-grown acquisition target thus contributing valuable assets to the growing appetites for regenerative medicine among the global multinational players.”

This story was produced by Postmedia Works on behalf of Market One Media Group for commercial purposes. Postmedia’s editorial departments had no involvement in the creation of this content.

To read this article on the Financial Post website, click here.

FINANCIAL POST ARTICLE – SPONSORED BY REPLICEL LIFE SCIENCES

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Clinical trial site located at IUF Leibniz-Institut für umweltmedizinische Forschung GmbH in Germany

VANCOUVER, BC – September 15, 2015 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, today announced that its European Phase 1 study (NCT02391935) of intradermal injections of RCS-01 to treat aged and sun damaged skin has been initiated at the IUF Leibniz-Institut für umweltmedizinische Forschung GmbH in Germany. To learn more about the trial, or to determine if you meet eligibility criteria, please visit https://www.clinicaltrials.gov/ or click here.

“We anticipate fast patient enrollment and 6-month data in autumn 2016. We look forward to analyzing the safety of triple injections of our autologous cellular product, RCS-01, as a potential treatment for intrinsic aging, wrinkling and solar degeneration of the skin,” stated Dr. Rolf Hoffmann, Chief Medical Officer & Director of RepliCel. “We will also be measuring 10 different biomarkers related to skin aging which will give us a good indication of the changes in the skin. The repair of damaged skin at the cellular level, via the natural cell-based production of type 1 collagen and other important matrix molecules, would fundamentally change the aesthetics market currently flooded with dermal products that temporarily reverse the signs of aging using fillers and hyaluronic acids.”

“This RCS-01 trial initiation represents the second clinical trial of RepliCel’s non-bulbar dermal sheath fibroblast (NBDS) platform to be initiated this year, the first being RCT-01 in Canada for chronic tendinosis. Given the estimated time frame for enrollment and interim data reveal of both programs, we anticipate results in the second half of 2016,” stated Lee Buckler, Vice President Business and Corporate Development. “Both clinical trials are designed to provide the company with much data to support our current NBDS platform licensing discussions as well as demonstrate a basis for the potential expansion into other medical indications.”

About the Study
The study is projected to include 30 participants, male and female. Participants will be selected based on their health status, current/past medications and ability to adhere to protocol-related requirements. After providing informed consent at the first visit, participants will be evaluated against the study inclusion/exclusion criteria and will provide blood samples for screening assessments. If suitable for participation, a biopsy will be taken from the scalp from which RSC-01 will be prepared, and four treatment evaluation sites will be identified on the buttocks – two on each side. Participants will be randomized into one of two treatment groups; one will receive injections of RCS-01 or placebo or a ‘sham’ injection (a needle penetration without injection of liquid) while the other (placebo group) will only receive placebo or a ‘sham’ injection. The primary purpose of this study is to assess the safety profile of RCS-01 injections compared to placebo injections. The study will also measure the impact RCS-01 injections have on skin markers related to aging through evaluation of gene expression profiles. This trial design is intended to deliver data related to how, and the degree in which the product injection improves the fullness of the extracellular matrix supporting the skin. This data will be critical to designing future trials intended to affect the skin’s appearance in areas of aesthetic importance.

For more information, please contact:

CORPORATE/MEDIA:
Tammey George, Director of Communications
Telephone: 604-248-8696 / tg@replicel.com

INVESTOR RELATIONS:
Lee Buckler, VP Business & Corporate Development
Telephone: 604-248-8693 / lee@replicel.com

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German-based trial to test RCS-01 cell therapy treatment for aged and sun-damaged skin

VANCOUVER, BC – July 21, 2015 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, today announced it has received two important approvals required to conduct its RCS-01 phase 1 human clinical trial. The first is from the Ethics Committee of the Faculty of Medicine Heinrich-Heine Universität Duesseldorf, a criteria for clinical trial initiation, and the second is approval from the Leibniz-Institut for its Tissue Procurement Authorization (TPA). Ethics Committee approval and TPA are two parts of a three-part Clinical Trial Application (CTA) approval process required to conduct human clinical trials in Germany. The final approval required is from the Paul Ehrlich Institute (PEI), the German regulatory body. If cleared to proceed, the proposed trial will be conducted at the IUF Leibniz-Institut für umweltmedizinische Forschung GmbH in Germany.

RepliCel’s non-bulbar dermal sheath-derived fibroblast therapy entitled RCS-01 provides a promising treatment for intrinsically or extrinsically aged/damaged skin by providing UV-naïve collagen-producing cells directly to affected areas. RepliCel’s unique manufacturing technology allows for isolation of fibroblasts derived from anagen-hair follicle mesenchymal tissue, which elicit more efficient replication potential in culture. Furthermore, the proprietary culture conditions in which RCS-01 is manufactured enables these cells to maintain plasticity. This plasticity allows the cells to adapt to the microenvironment and respond to the mechanical or surrounding stimuli after injection, leading to robust production of type 1 collagen and elastin and their proper alignment within the tissue. For more information on this trial, please visit www.clinicaltrials.gov.

“The market for dermal fillers currently represented almost 6 million procedures and expenditures of almost $2 billion in 2013 according to statistics provided by the American Society of Plastic Surgeons. RCS-01 could disrupt this market by providing patients with a filler comprised of their own fibroblast cells – a much more compelling long-term solution than hyaluronic acid which dissipates in approximately six months,” commented Dr. Rolf Hoffmann, Chief Medical Officer. “Successfully treating aged and sun damaged skin with our therapy would allow a patient to have a renewed dermal appearance by repopulating the patient’s aged and depleted fibroblast cells which are the key cells responsible for maintaining and repairing the skin’s extracellular matrix.”

“These two important approvals bring us closer to initiation of our RCS-01 clinical trial. Approval from the PEI will enable us to immediately begin the recruitment phase of our trial. With the initiation of this study, we will have two clinical trials using our NBDS-fibroblasts underway; RCT-01 in Canada and RCS-01 in Germany,” stated David Hall, CEO.

Trial Design
The study is anticipated to include 30 participants (24 treated, 6 placebo), male and female, who will receive either an injection of RCS-01 or placebo (on a 4:1 treatment-to-placebo ratio). The primary purpose of this study is to assess the safety profile of RCS-01 injections compared to placebo injection at 6 and 12 months. The study will also measure the impact these injections will have on skin markers related to aging through evaluation of gene expression profiles at 3 and 6 months. 16 participants will be biopsied for gene expression of skin aging markers and 12 participants biopsied for histopathology analysis to assess structural characteristics and molecular markers associated with skin aging. This trial design is intended to deliver biologic data related to how, and the degree in which the product injection improves the fullness of the extracellular matrix supporting the skin. This data will be critical to designing future trials intended to affect the skin’s appearance in areas of aesthetic importance.

About Aging Skin
The dermis and epidermis components of the skin lose thickness with age. Solar radiation, particularly UVA, is known to penetrate deep into the dermal layer, damaging fibroblasts, which are the major cellular component of the dermis. Similarly, there are some studies reporting that air pollutants/nanoparticles may also penetrate transepidermally, negatively impacting the dermal layer. The damage caused by external stimuli include DNA strand breaks and mutations, which, if not repaired properly, can lead to cell death. Similarly, oxidative stress caused by smoking leads to not only damages to DNA but also to other cellular components such as proteins and lipids. Accumulation of damages to cellular proteins and DNA from years of exposure to extrinsic insults can lead to physiological changes to the skin that are naturally-irreversible. Such changes are often associated with reduction in fibroblasts, disorganization of collagen fibrils and decreased production of collagen, elastin and other glycoproteins that provide structural support and stability to the extra cellular matrix “ECM” network. Such changes to the dermal components are detrimental to maintaining mechanical tensile ability and structural integrity of the skin.

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function. The company’s RCT-01, RCS-01, and RCH-01 cell therapies are designed to treat chronic tendinosis, damaged or aging skin, and pattern baldness. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles. The company is also developing a propriety injection device optimized for the administration of its products and licensable for use with other dermatology applications. The company’s product pipeline is comprised of multiple clinical trials anticipated to launch through Q1 2015 in addition to Shiseido’s own clinical trial of RCH-01 and the device in late prototype development. Visit www.replicel.com for additional information.

For more information please contact:

CORPORATE/MEDIA:
Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com

INVESTOR RELATIONS:
Lee Buckler, VP Business & Corporate Development
Telephone: 604-248-8693
lee@replicel.com

This press release contains forward-looking information that involve various risks and uncertainties regarding future events, including statements regarding our approach and our technology, expected and planned upcoming milestones and events, and the timing of trials. Such forward-looking information can include without limitation statements based on current expectations involving a number of risks and uncertainties and are not guarantees of future performance of RepliCel. There are numerous risks and uncertainties that could cause actual results and RepliCel’s plans and objectives to differ materially from those expressed in the forward-looking information, including: approval to conduct clinical trials; approval from Paul Ehrlich Institute (PEI), the German regulatory body; delays enrolling clinical trial participants; negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Actual results and future events could differ materially from those anticipated in such information. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, RepliCel does not intend to update these forward-looking statements.

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Click here to view the article on Cantech Letter

Vancouver-based RepliCel Life Sciences (TSXV:RP) concentrated on hair regeneration until 2011, participating in the $3 billion annual male pattern baldness industry. But when the far-reaching effects of its solution became apparent to its founders, RepliCel began expanding its offer to apply the technique of using cell therapy to encourage the healing of damaged or injured tissues to other body parts.

The company recently partnered with Tokyo-based cosmetic giant Shiseido, offering RepliCel access to the vast Asian market.

Cantech Letter talked to RepliCel as part of our “Five Questions” series. Our “Five Questions” Series runs all this week, posing the same five questions to up-and-coming Canadian innovation sector companies.

What does your company do?

RepliCel Life Sciences Inc. is a regenerative medicine company focused on developing autologous cell therapies for the treatment of musculoskeletal tissue injuries, aging and UV-damaged skin and pattern baldness. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles.

RepliCel’s strategy is to license its assets to partners for late-stage development and commercialization. Shiseido, one of the world’s largest cosmetic companies, has an exclusive license for RepliCel’s pattern baldness product, RCH-01, in certain Asian countries including Japan, China and South Korea.

What problem are you trying to solve?

RepliCel is developing autologous cell therapies which address conditions caused by a deficit of the healthy, active cells required for normal healing and function.

RepliCel’s propriety injector device (RCI-02) is programmed to control depth, dose, and volume of the injection and allows for widespread injections across broad areas. In addition, RepliCel’s device has a built-in peltier element which numbs the skin just prior to injection eliminating the need for anesthetic. These features distinguish Replicel’s dermal injector from any others currently on the market.

How is your solution better than what is currently offered?

The regeneration of chronically injured tendon, the natural rejuvenation of the extra-cellular matrix under the dermis of those with aging or sun-damaged skin, and the regrowth of hair for those people suffering from pattern baldness attributed to androgenic alopecia are not conditions which can be resolved by currently available products or treatments.

How big is the market you are addressing?

The combined total addressable market size for pattern baldness, skin rejuvenation, tendon repair, and a next-generation dermal injector potentially valuable for any kind of dermal injection is understandably large – easily estimated at >$2 billion annually.

What will you be working to accomplish in the next year?

2015 is on track to be a transformative year for RepliCel as we move each of our assets into next-stage of clinical development. We anticipate accomplishing the following over the next 12 months:

-Clinical data from the RCT-01 (chronic Achilles tendinosis) trial in Canada and from
-Clinical data from the RCS-01 (aging and sun-damaged skin) trial in Germany
-Receipt of a CE mark clearing the RCI-02 dermal injector for sale in Europe
-Execution of a licensing partnership in Japan for RCT-01 or RCS-01
-Execution of a global licensing partnership for RCI-02 for select product(s)
-Launch of our phase 2 RCH-01 (pattern baldness) clinical trial in Germany
-Shiseido’s launch of its RCH-01 (pattern baldness) clinical trial in Japan
-Technology transfer complete to a contract manufacturing facility in North America

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Conference program to include presentations on the clinical development of RepliCel’s skin rejuvenation, hair regeneration, and tendon repair technologies

VANCOUVER, BC – June 5, 2015 – RepliCel Life Sciences Inc. (TSX.V: RP) (OTCQB: REPCF), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced today that RepliCel’s technology founders and management will be attending the 23rd World Congress of Dermatology (“WCD”) 2015 held in Vancouver, British Columbia, Canada. This year’s congress will take place from June 8 – 13, 2015 at the Vancouver Trade and Convention Centre. The RepliCel team will be involved in multiple sessions spanning the length of this conference. Chief Scientific Officer, Dr. Kevin McElwee will be chairing a session entitled: “Hair Biology and its exploitation in health and disease” on Tuesday, June 9th from 8 – 10 AM PST in West 2015-107. Dr. McElwee will also be giving a poster presentation entitled: “Hair-follicle derived mesenchymal cells in cell therapy: multiple therapeutic applications” on Thursday, June 11th from 9 AM – 1PM PST. Chief Medical Officer, Dr. Rolf Hoffmann, will be coming from Germany to co-chair a session entitled: “Alopecia Areata” on Thursday June 11th from 2:30 – 4:30 PM PST in West 223-224. Also present at this conference will be RepliCel’s CEO David Hall, VP Business and Corporate Development Lee Buckler, and Director of Research and Development Dr. Hisae Nakamura.

“We are pleased Vancouver is host to this year’s World Congress of Dermatology and excited to be participating among the world’s leading experts advancing science and technology in dermatology. We congratulate the event organizers, and in particular Drs. Jerry Shapiro, Harvey Lui and David McLean, who were amongst the visionary founding group of our company, on putting together what promises to be an outstanding program and world-class event,” stated David Hall, CEO of RepliCel. “We look forward to the contributions of our Chief Scientific Officer, Dr. Kevin McElwee, and Chief Medical Officer, Dr. Rolf Hoffmann, the scientific co-discoverers of RepliCel’s technology, in the conference at sessions highlighting various aspects of RepliCel’s hair follicle-derived technologies.”

About World Congress of Dermatology
WCD is the world’s oldest and longest-running international dermatology meeting, with the first Congress in 1889. It is presented by the International League of Dermatological Societies and will feature over 200 scientific sessions featuring experts and companies in the medical, surgical and cosmetic dermatological fields. The WCD’s focus is to bring the interests and priorities of the dermatology industries to an international, professional focus. For more information about the congress, visit The World Congress of Dermatology website.

About RepliCel
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function. The company’s RCT-01, RCS-01, and RCH-01 cell therapies are designed to treat chronic tendinosis, damaged or aged skin, and pattern baldness. Shiseido has an exclusive license for RCH-01 in certain Asian countries including Japan, China, and South Korea. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles. The company is also developing a proprietary injection device optimized for the administration of its products and licensable for use with other dermatology applications. The Company’s product pipeline is comprised of multiple clinical trials anticipated to launch through Q1 2015 in addition to Shiseido’s own clinical trial of RCH-01 and the device in late prototype development. Visit www.replicel.com for additional information.

For more information please contact:

MEDIA:
Tammey George, Director of Communications
Telephone: 604-248-8696 / tg@replicel.com

INVESTOR RELATIONS:
Lee Buckler, VP Business & Corporate Development
Telephone: 604-248-8693 / lee@replicel.com

This press release contains forward-looking information. There are numerous risks and uncertainties that could cause actual results and RepliCel’s plans and objectives to differ materially from those expressed in the forward-looking information, including: approval to conduct clinical trials; negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Actual results and future events could differ materially from those anticipated in such information. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, RepliCel does not intend to update these forward-looking statements.

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RepliCel Targets Low-Risk, Near-Term Opportunities in Regenerative Medicine

By: Gail Dutton

The regenerative medicine company RepliCel Life Sciences is developing potential cures for chronic tendinosis, damaged or aging skin, and pattern baldness by reseeding affected areas with specific cell populations isolated from patients’ own healthy hair follicles.

RepliCel is picking the low-hanging fruit of regenerative medicine—low technological risk, underserved markets, clear clinical indications. Furthermore, commercial success is not dependent on successful reimbursement negotiations.

“On the technical level, we’re not asking these cells to do anything other than what they naturally do, or be anything more than they are,” CEO David Hall says. “These are adult, somatic cells derived from the patient which we simply isolate and grow. We’re not differentiating, genetically modifying, or manipulating these cells in any way.

At present, there is no therapy to treat the underlying causes of tendinosis, which include a deficit of collagen-producing tenocytes (fibroblasts). RepliCel’s approach to the treatment of tendinosis uses injections of cultured autologous, collagen-producing, nonbulbar dermal sheath cells into the injury site to stimulate tendon regeneration

From the scientific and manufacturing perspective, RepliCel is using the hair follicle as the cell source because the cells are simple to collect, grow well in culture, and are both relatively naive and highly functional. On a clinical level, the company is simply addressing a deficit of active cells in the patient by local delivery of cells shown to function in ways needed to solve a human condition such as tendinosis or pattern baldness.

“The cells are injected in ways and places that largely eliminate any concerns around in vivo cell migration,” explains Hall. “[This approach ensures] enough cells stay in situ and viable to affect a sustained effect.”

Indications

For tendinosis—a disrupted healing cycle of the tendon—nonbulbar dermal sheath (NBDS) fibroblast cells are isolated from a biopsy of hair follicles taken from the back of the scalp. After these cells are replicated, creating populations of millions of cells, they are injected into the wound site to jump-start the disrupted wound repair.

In early-stage trials, clinical advisory board member David Connell, M.D., used a similar approach with tendinosis patients who had been failed by other therapies. The NBDS approach returned these patients to painless, near-normal function.

In the next 18 months, Hall says he expects to conclude a Phase I/II study at the University of British Columbia involving 28 participants. As yet, there is no approved therapy that treats the underlying cause of this chronic condition.

This same NBDS platform technology also may be used to repair damaged and aging skin. RepliCel filed a clinical trial application for Germany in February.

Phase II trials to treat baldness—specifically, androgenetic alopecia—will begin this year. For this therapy, dermal sheath cup (DSC) cells are isolated from the base of the hair follicle, replicated into the millions, and injected to the area of thinning hair.

“DSC cells are responsible for maintaining the number of dermal papillae cells, which directly corresponds to the hair thickness,” Hall explains. “We are simply delivering a volume of androgen-insensitive DSC cells into an area where androgen-sensitive DSC cells have disappeared … to restore the normal hair follicle cycle.”

RepliCel’s autologous cell therapy utilizes dermal sheath cup (DSC) cells to treat androgenetic alopecia. DSC cells are responsible for the regulation of the volume of dermal papillae (DP) cells, which are responsible for the thickness and growth of a hair fiber. Another RepliCel technology uses nonbulbar dermal sheath (NBDS) fibroblast cells to treat tendinosis.

In animal studies, this approach grew hair on the feet of mice (which have no hair follicles there). When these cells were injected into their ears, the healthy cells migrated into resident hair follicles, making that hair thicker.

In humans, this approach could address existing hair follicle damage. “This is our longer-term program,” Hall stresses. RepliCel will begin a clinical trial in Germany this year involving 160 patients. Hall says results from RepliCel’s Phase I and Phase II clinical trials for chronic tendinosis and UV-damaged/aged skin are expected in 2016.

Manufacturing and Delivery

RepliCel currently uses industry-standard fetal calf serum in its manufacturing process, but is validating a serum-free process. “This is a distinguishing commercial step,” Hall asserts. “[It] adds value to our therapeutics program.” Hall notes that RepliCel anticipates licensing the process.

RepliCel is also investigating the potential of using its cells in an allogeneic setting. Hall says that a successful licensing effort could enhance both the business model and the value of company assets.
RepliCel also is developing a dermal injector to ensure controlled, consistent delivery of the cells to the skin and scalp. RepliCel expects that this device will control cell volume and delivery depth while minimizing shear force to the cells.

“We have also incorporated a Pelletier element into the tip, which reduces or removes the need for pre-injection anesthetics,” Hall informs. This second-generation injector is available for licensure. RepliCel plans to file for the CE mark in the latter half of 2015.

Partnerships

RepliCel already has a partnership with Shiseido in Japan to co-develop and commercialize RepliCel’s RCH-01 technology as a therapy for thinning hair in China, South Korea, and the ASEAN nations. RepliCel is actively pursuing similar geographically focused licensing and co-development partnerships for its other products.

It also is commercially active in Japan, where recent changes to Japanese regulations for regenerative medicine “have dramatically changed the pathway toward revenue generation,” Hall remarks. Those changes allow products that have demonstrated safety and potential efficacy in early-stage trials to gain conditional marketing approval. That lets them be sold and reimbursed up to seven years before being subjected to a final marketing approval review.

“In the current Japanese environment, we can generate data while simultaneously generating revenue and continuing to develop the same technology in the West,” Hall confides. He suggests that as a result of these regulatory changes, Japan will become important as a test bed for regenerative medicine.

RepliCel’s business model seems well-suited to Japan’s new regulatory stance for regenerative medicine. “We’re built to discover, validate, and license,” Hall states. “Commercialization is done with partners.”

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To read the full article on The Province newspaper website click here\\n

\\n

A Vancouver-based anti-aging company is betting that the fountain of youth flows with antifreeze produced by an Antarctic fish.

\\n

Sirona Biochem has synthesized compounds from glyco-proteins made by the Nototenioid that enable the homely but hardy fish to survive in sub-zero temperatures.

\\n

The company has created an age-busting technology to protect people’s skin and restore its youthfulness, says Attila Hajdu, Sirona’s chief business development\\n officer.

\\n

“We’ve developed an anti-aging compound that has been scientifically proven to extend cell life and prevent cell death,” Hajdu says.

\\n

“It’s remarkably exciting.”

\\n

Sirona belongs to a group of B.C. age-busters at the cutting edge of the global push to help people live longer.

\\n

Many B.C. residents would be “shocked and dumbfounded” to learn that companies in their own backyard are making real progress in extending people’s lives,\\n says Paul Drohan, president-CEO of

\\n

LifeSciences B.C., a Vancouver-based industry association.

\\n

Not content to simply give people more years, B.C. biotech companies are responding to boomers’ desire to age gracefully by staying healthy and active,\\n Drohan says.

\\n

“The idea is to keep people on their bikes and paddle boards longer, to keep them running longer, and looking good while they’re doing it,” Drohan says.

\\n

It’s no accident B.C. companies are at the leading edge of anti-aging research.

\\n

The province has top-notch biotech talent and a good track record for “translation” — taking lab discoveries and turning them into commercial products,\\n Drohan says.

\\n

The province scored an early victory in the anti-aging war in the late 1980s when Vancouver ophthalmologist Jean Carruthers and Alastair Carruthers, her\\n dermatologist husband, discovered the cosmetic powers of a toxin called Botox in easing lines and wrinkles.

\\n

B.C. seniors’ appetite for anti-aging products or therapies has only grown.

\\n

The province already has the longest average life expectancy in Canada — 84 for women, versus the national average of 83; 80 for men, against the\\n national average of 79.

\\n

“We probably have one of the most active elderly populations in the country,” Drohan says.

\\n

“They’ve made sure they’ve lived a healthy life and they’re interested in advances in anti-aging and regenerative medicine.”

\\n

Vancouver is a pinpoint in the global anti-aging market. U.S.-based firm BCC Research estimates that people over 65 will make up 12 per cent of the world’s\\n market by 2030, up from seven per cent in 2010.

\\n

As the planet’s population ages, the global market for anti-aging products is soaring.

\\n

BCC expects the worldwide market for anti-aging cosmetic and pharmaceutical products to climb to $345.8 billion US in 2018 from $249.3 billion in 2012.

\\n

The related market for regenerative medicine, which aims to restore functional ability to tissues and organs, should explode to $67.6 billion US in 2020\\n from $16.4 billion in 2013, according to a separate report.

\\n

B.C.’s anti-aging companies want to grab a piece of this action.

\\n

But the field is fraught with risk as companies spend years demonstrating to regulators their products are safe and effective, Drohan says.

\\n

“Some discoveries will turn into huge commercial successes and some, unfortunately, will not prove their end points,” he says.

\\n

It can take 10 years for a product to pass clinical trials and be approved by regulators as being market-ready.

\\n

Following are four B.C. companies that already have anti-aging products or are well along the way to putting them on the market.

\\n

BALDNESS TREATMENT IN THE WORKS\\n

RepliCel Life Sciences wants to turn back the clock on how you look and how you feel.

\\n

The Vancouver-based company is exploring the frontiers of regenerative medicine to treat injured tendons, pattern baldness and skin damaged by sun and\\n age.

\\n

The world’s scientists have advanced from using chemical compounds to proteins and antibodies in their bid to reverse age-triggered wear and tear, says\\n Lee Buckler, RepliCel’s vice-president of business and corporate development.

\\n

“We are the next wave of biotechnology. We use cells as medicines. We call this cell therapy,” Buckler says. “We’ll not only keep people looking younger\\n but acting younger. It’s as much a matter of keeping the guy on the golf course as it is looking good while he’s golfing.”

\\n

At the core of RepliCel’s age-busting technology are cells called fibroblasts extracted from a patient’s own hair follicles. Fibroblasts produce Type 1\\n collagen, a protein that helps the body repair skin and connective tissue.

\\n

“It’s like personalized medicine. You don’t have to pump yourself full of synthetics anymore. This uses your own cells.”

\\n

Injections of fibroblasts have been proven in the lab to help tendons repair themselves, reduce wrinkles and tone up skin, Buckler says. A different set\\n of cells extracted from follicles is used to regenerate hair.

\\n

The company has embarked on an aggressive program of trials on human subjects to prove to health regulators its approaches are safe and effective.

\\n

The need for three sets of trials for each therapy means RepliCel’s therapies are several years away from reaching the North American market, Buckler says.

\\n

RepliCel scored a coup in 2013 when it formed a partnership with Japanese cosmetic giant Shiseido. That partnership, and Japanese regulatory changes, mean\\n RepliCel’s pattern baldness treatment will likely reach the Japanese market sooner than anywhere else, Buckler says.

\\n

Formed in 2010, RepliCel trades on the TSX venture exchange and employs about a dozen people.

\\n

SAVING FACE\\n

\\n

The first battleground in Sirona Biochem’s fight against aging is the mirror.

\\n

The Vancouver-based company is developing anti-aging products based on the antifreeze produced by an Antarctic fish to protect and regenerate human skin,\\n says Attila Hajdu, the company’s chief business development officer.

\\n

“Everyone looks in the mirror. If we help make them happier with what they see then we’re improving their lives,” Hajdu says.

\\n

The chemical compounds that Sirona has synthesized based on the fish’s glyco-proteins go beyond their power to lighten skin and protect it from the impact\\n of age and sun damage.

\\n

The synthesized compounds’ cell-preserving powers also mean they can be used in organ and tissue transplants, Hajdu says.

\\n

The company has licensed its compounds to companies around the world in return for fees and royalty payments.

\\n

Sirona, which began in 2009, employs 15 people and trades on the TSX venture and Frankfurt stock exchanges.

\\n

It conducts research at a laboratory in France.

\\n

FUELLING STEM CELL RESEARCH\\n

\\n

Vancouver-based Stemcell Technologies hands global scientists the tools they need to help people live longer.

\\n

Stemcell has become Canada’s largest biotech company by selling nutritious soup — technically, it’s called “tissue culture media” — that scientists\\n need to grow specialized stem cells for anti-aging research.

\\n

“We provide the picks and shovels for the regenerative medicine gold rush,” says CEO and owner Allen Eaves.

\\n

Scientists, who obtain stem cells from sources such as skin and blood, use the company’s products to research cell therapies for everything from diabetes\\n to Parkinson’s disease.

\\n

Tissue engineering to regenerate organs is an area of intense research.

\\n

“When you have kidney failure, ideally, you will be able to engineer and construct a replacement kidney using a patient’s own cells rather than looking\\n for a donor,” Eaves says.

\\n

Eaves founded the company in 1993 as a spinoff from the Terry Fox Laboratory at the B.C. Cancer Agency. It employs 650 people, 500 of whom are in Vancouver.

\\n

Stemcell sells products to about 70 countries. It has annual revenues of about $100 million and has been profitable since its launch. The company has committed\\n $350 million to research and development over the next 10 years.

\\n

HALTING A RENEGADE ENZYME\\n

\\n

ViDA Therapeutics is working to help people shake off the effects of age by sticking a sock in the mouth of one of the body’s trickiest frenemies.

\\n

The immune system produces an enzyme called granzyme B to target and kill infected cells. So far, so good.

\\n

But several years ago researchers at Vancouver’s St. Paul’s Hospital found high levels of granzyme B outside of cells in aged and damaged human skin. They\\n also discovered high levels of the enzyme in the occurrence of other ailments such as rheumatoid arthritis, fibrosis and heart disease.

\\n

Knowing they were on a promising path, research scientist and University of B.C. professor Dave Granville joined forces with Vancouver biotechnology veteran\\n Alistair Duncan in 2008 to launch viDA.

\\n

Since then, viDA’s research team has developed a library of molecular compounds to inhibit granzyme B.

\\n

“Granzyme B is running amok and causing damage from rheumatoid arthritis to heart conditions to neural inflammation,” Duncan says. “If you picture granzyme\\n B as a Pac-Man that goes around gobbling, we stick a sock in its mouth so it can’t gobble anymore, allowing the healing process to begin.”

\\n

Privately owned viDA is focused on research to develop a cream to tackle skin aging and discoid lupus erythematosus, an auto-immune disease aggravated\\n by sunlight that can cause facial scarring. Pop musician Seal has this condition.

\\n

ViDA is also exploring how its granzyme B inhibitors may be used to treat other diseases such as aneurysms and chronic obstructive pulmonary disease.

\\n

Getting a skin treatment through the regulatory pipeline to market may take seven to eight years, Duncan says.\\n
Given that granzyme B levels rise with age, baby boomers may wish to pay attention.\\n
pluke@theprovince.com\\n
twitter.com/ProvMoney\\n
© Copyright (c) The Province

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Autologous cell therapy, RCS-01, to be investigated as a potential treatment for aged, UV-damaged skin

VANCOUVER, BC – February 23, 2015 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, today announced the submission of a Clinical Trial Application (CTA) to the German Competent Authority, the Paul-Ehrlich-Institut (PEI), requesting clearance to initiate a Phase 1 clinical trial investigating the use of RCS-
01 to treat patients suffering from aged and UV-damaged skin. RCS-01 is a cell-based product highly expressive of type 1 collagen comprised of autologous, cultured fibroblast cells isolated from the non-bulbar dermal sheath (NBDS) of the hair follicle.

The study, entitled, “Randomized, double-blind, placebo-controlled, single-centre, phase 1 safety study of intra-dermal injections of RCS-01 in male and female subjects (50 to 65 years old)”, addresses the inherent deficit of active fibroblasts required for the production of type 1 collagen, elastin and other critical extracellular dermal matrix components found in youthful skin. If cleared to proceed, the proposed trial will be conducted at the IUF Leibniz-Institut für umweltmedizinische Forschung GmbH in Germany.

“Skin aging is caused by a reduction in metabolically active fibroblasts, disorganization of collagen fibrils and decreased production of collagen, elastin and other glycoproteins that provide structural support and stability to the extra cellular matrix. We believe that RCS-01 has the potential to reverse the signs of aging by providing RepliCel’s UV-naïve collagen-producing fibroblast cells directly into affected areas of the skin. This trial is an important step toward the development of a cell-based treatment for fine wrinkle lines which are typically seen in the face, hands and other UV-affected areas,” commented Dr. Rolf Hoffmann, RepliCel’s Chief Medical Officer.

“RCS-01 is the second product, utilizing our hair follicle-derived fibroblasts, that we anticipate entering clinical testing in 2015 – the first being RCT-01 for chronic tendinosis. While the primary endpoint of this trial is to demonstrate the safety of RCS-01 injections into the skin, the trial is also designed to collect quantitative and qualitative data demonstrating the product’s effects, at a molecular level, on skin aging and UV-damage,” stated David Hall, RepliCel’s CEO. “This fibroblast-based program should be viewed as a broad platform which we will apply to multiple indications characterized by tissue damage and incomplete healing. We anticipate data from these NBDS trials (RCS-01 and RCT-01) will contribute to the early establishment of the commercial value of our fibroblast platform.”

“Initiation of this trial is another milestone in our 18-month strategy to create maximum value around the company’s fibroblast program,” stated Lee Buckler, RepliCel’s Vice-President of Business and Corporate Development. “In addition to our clinical trial programs, our team is working on manufacturing optimization involving state-of-the-art bioreactor technology and serum-free media, development of a proprietary injector device to reduce the human variability of our product injections, and pre-clinical research validating the immune-privilege of both our cell platforms in order to support the potential for allogeneic use of RepliCel’s products.”
Further details of the clinical program evaluating intra-dermal injections of RCS-01 will be provided once it has been cleared by the PEI.

About Skin Aging
Skin is considered one of the most prominent indicators of one’s age and health. Maintenance of healthy skin is dictated by intrinsic and extrinsic factors. While intrinsic factors (i.e. chronologic age, sex and genetic makeup) cannot be modified, the adverse effects caused by extrinsic factors such as UV radiation and smoking can be prevented or minimized by lifestyle modification. Although these extrinsic effects can be modulated, the extent to which they can be modified varies significantly among individuals, which largely depends on one’s ability to detoxify and repair such damages.

Damage or loss of fibroblasts in the skin leads to reduction in overall production of collagen, elastin and other extracellular matrix (“ECM”) components such as hyaluronic acid and glycosaminoglycan which provide structural support and stability to the ECM. Collagen, in particular, plays a significant role in providing the dermis with tensile force and elasticity that is reflected in a ‘youthful’ appearance. This structurally important protein is produced mainly by fibroblasts in the dermis. The interactions between fibroblasts and ECM proteins are orchestrated by specialized cell surface receptor proteins, called integrins, which extracellularly bind type I collagen and intracellularily bind cytoskeletal contractile proteins via anchor protein complexes. The mechanical tension maintained in the dermis by ‘pulling’ cytoskeletal contractile forces and ‘resisting’ collagen fibrils provides fibroblasts a flattened/spread-out appearance, which is characteristic of a younger dermis. In contrast, fibroblasts in an aged dermis have a collapsed appearance due to reduced cytoplasm and lack of cell attachment to collagen fibrils, which are often fragmented in the elderly dermis, thus limiting tensile capacity.

RepliCel’s RCS-01 product holds promise as a treatment for intrinsically or extrinsically aged/damaged skin by providing UV-naïve collagen-producing cells directly to affected areas. RepliCel’s unique manufacturing technology allows for isolation of fibroblasts derived from anagen-hair follicle mesenchymal tissues which elicit efficient replication potential in culture. Furthermore, the proprietary culture conditions in which RCS-
01 is manufactured enables these cells to maintain plasticity. This plasticity allows the cells to adapt to the microenvironment and respond to the mechanical or surrounding stimuli after injection, leading to robust production of type 1 collagen and elastin and their proper alignment within the tissue.

The market for dermal fillers currently represents almost 6 million procedures per year and expenditures of almost $2 billion in 2013 according to statistics provided by the American Society of Plastic Surgeons.

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal healing and function. The company’s RCT-01, RCS-01, and RCH-01 cell therapies are designed to treat chronic tendinosis, damaged or aging skin, and pattern baldness. Shiseido Company, Limited has an exclusive license for RCH-01 in certain Asian countries including Japan, China and South Korea. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles. The company is also developing a propriety injection device optimized for the administration of its products and licensable for use with other dermatology applications. The company’s product pipeline is comprised of multiple clinical trials anticipated to launch in 2015 in addition to Shiseido’s own clinical trial of RCH-01 and the device in late prototype development. Visit www.replicel.com for additional information.
For more information please contact:

CORPORATE/MEDIA:
Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com
www.replicel.com

INVESTOR RELATIONS:
R. Lee Buckler, Vice President of Business and Corporate Development
Telephone: 604-248-8693
info@replicel.com

This press release contains forward-looking information that involve various risks and uncertainties regarding future events, including statements regarding our approach and our technology, expected and planned upcoming milestones and events, and the timing of trials. Such forward-looking information can include without limitation statements based on current expectations involving a number of risks and uncertainties and are not guarantees of future performance of RepliCel. There are numerous risks and uncertainties that could cause actual results and RepliCel’s plans and objectives to differ materially from those expressed in the forward-looking information, including: approval to conduct clinical trials; negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Actual results and future events could differ materially from those anticipated in such information. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, RepliCel does not intend to update these forward-looking statements.

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Autologous cell therapy, RCS-01, to be investigated as a potential treatment for aged, UV-damaged skin

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal healing and function. The company’s RCT-01, RCS-01, and RCH-01 cell therapies are designed to treat chronic tendinosis, damaged or aging skin, and pattern baldness. Shiseido Company, Limited has an exclusive license for RCH-01 in certain Asian countries including Japan, China and South Korea. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles. The company is also developing a propriety injection device optimized for the administration of its products and licensable for use with other dermatology applications. The company’s product pipeline is comprised of multiple clinical trials anticipated to launch in 2015 in addition to Shiseido’s own clinical trial of RCH-01 and the device in late prototype development. Visit www.replicel.com for additional information.
For more information please contact:

CORPORATE/MEDIA:
Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com
www.replicel.com

INVESTOR RELATIONS:
R. Lee Buckler, Vice President of Business and Corporate Development
Telephone: 604-248-8693
info@replicel.com

This press release contains forward-looking information that involve various risks and uncertainties regarding future events, including statements regarding our approach and our technology, expected and planned upcoming milestones and events, and the timing of trials. Such forward-looking information can include without limitation statements based on current expectations involving a number of risks and uncertainties and are not guarantees of future performance of RepliCel. There are numerous risks and uncertainties that could cause actual results and RepliCel’s plans and objectives to differ materially from those expressed in the forward-looking information, including: approval to conduct clinical trials; negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Actual results and future events could differ materially from those anticipated in such information. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, RepliCel does not intend to update these forward-looking statements.

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Meetings focused on investors, analysts, and potential partners for RCS-01 and RCT-01 cell therapies

VANCOUVER, BC – January 7, 2015 – RepliCel Life Sciences Inc. (TSX.V: RP) (OTCQB: REPCF), a clinical stage regenerative medicine company focused on the development of autologous cell therapies announced today that CEO and President, David Hall, and Vice-President of Business and Corporate Development, Lee Buckler, will be representing RepliCel Life Sciences Inc. at the Biotech Showcase 2015, January 12-14th in San Francisco, CA at the Parc 55 Wyndham in Union Square.

Hall will be presenting Monday, January 12th at 2:30 PM (ET) at C – Mission II on the 4th floor, providing updates on RepliCel’s clinical programs for chronic Achilles tendinosis (RCT-01), sun damaged and aging skin (RCS-01), and pattern hair loss (RCH-01) in addition to the development of its own proprietary injection device.

“The Biotech Showcase has become a central hub for the regenerative medicine industry during this healthcare investment week in San Francisco,” stated RepliCel CEO, David Hall. “It begins with the Alliance for Regenerative Medicine Industry Briefing on Monday morning and is followed by a series of public and private company presentations over the course of the conference including RepliCel Life Sciences.”

“We are pleased to use the opportunity next week presents us to drive our partnering discussions forward,” stated RepliCel VP, Lee Buckler. “2015 will be a busy year in terms of our clinical programs and data read outs and this week provides an opportunity to advance our company’s programs with analysts, bankers and potential development partners.”

The Biotech Showcase is one of the largest annual healthcare investor conferences and partnering meetings, dedicated to providing both public and private life sciences and biotechnology companies the opportunity to meet and present to investors and executives in the pharmaceutical industries. In its seventh year, Biotech Showcase is expected to attract upwards of 1,700 attendees and over 1,100 companies engaged in one-on-one meetings, plenary sessions, workshops and networking.

About RepliCel
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function. The company’s RCT-01, RCS-01, and RCH-01 cell therapies are designed to treat chronic tendinosis, damaged or aged skin, and pattern baldness. Shiseido has an exclusive license for RCH-01 in certain Asian countries including Japan, China and South Korea. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles. The company is also developing a propriety injection device optimized for the administration of its products and licensable for use with other dermatology applications. The Company’s product pipeline is comprised of multiple clinical trials anticipated to launch through Q1 2015 in addition to Shiseido’s own clinical trial of RCH-01 and the device in late prototype development. Visit www.replicel.com for additional information.

For more information please contact:

MEDIA:
Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com

INVESTOR RELATIONS:
Lee Buckler, VP Business & Corporate Development
Telephone: 604-248-8693
lee@replicel.com

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To read the full report, click here: R. Lee Bucker on RepliCel Life Sciences

Regenerative medicine and cell therapies hold possibilities for achieving near miracles in a multitude of indications, from life-saving treatments to aesthetic applications. RepliCel Life Sciences Inc. (RP:TSX.V; REPCF:OTCQB) is tackling a mix of medical and cosmetic issues that include hair regeneration, repair of painful and debilitating tendon injuries and rejuvenation of damaged skin. In this interview with The Life Sciences Report, R. Lee Buckler, the company’s new vice president of business and corporate development, discusses his firm’s innovative technology platform and the upcoming milestones that could affect its shares.

The Life Sciences Report: Lee, you’ve made a recent career change and are now an executive at RepliCel. Tell us about that.

R. Lee Buckler: As of Oct. 7, I have been appointed vice president of business and corporate development for RepliCel Life Sciences Inc., which is engaged in development of cell-based regenerative medicine therapeutics in Canada, Europe and Japan through our licensing partner, Shiseido Company Ltd. (4911:TSE). I found RepliCel to be a very interesting company poised to go on an exciting run, and that enticed me to join the team.

TLSR: Prior to your work with RepliCel, what experience had you had in the cell therapy industry?

RLB: In 2000, I left the practice of law to join Allen Eaves in the Stem Cell Technologies group of companies, where I ran a company called Malachite Management Inc. In 2006, I was recruited by Progenitor Cell Therapy to run its business development, marketing, communication and sales before the NeoStem acquisition.

In 2008, I founded my own consulting firm, called the Cell Therapy Group (CTG), which focused exclusively on the cell therapy industry. In the early days, we did some communications work for clients, but for the bulk of my tenure with CTG, we were involved in a wide range of planning and business development work. Some of it was transactional, but other aspects included market and competitive intelligence, building strategies, identifying partners, targeting partners, engaging in partnership discussions on behalf of clients and the like. I also worked with fund managers and investors through education, namely technology and platform explanations.

“RepliCel is a very interesting company poised to go on an exciting run, and that enticed me to join the team.”

Over the past year, I worked as a consultant and on the board of directors positioning TheraVitae Inc. (private) for a merger with a company listed on the Toronto Venture Exchange. The merger is expected to complete in early November, and the company will be renamed Hemostemix Inc. I helped TheraVitae raise several million dollars as part of that process. Being on the road giving presentations to prospective investors is a new skill set for me, but I’ve found I really enjoy this side of the business.

TLSR: You are an attorney by training, but I see from your curriculum vitae that you did a couple of stints as a medical laboratory technician while you were still in law school. Is that what led you to the life sciences field?

RLB: Yes. I always joke with people that I didn’t get to the cell therapy/regenerative medicine industry through education—I got here more by osmosis. I was not a silver spoon kid; I had to work my way through school. So while I was studying to be an attorney, I ended up working in the lab of a leading cardiovascular investigator, who was involved in some clinical trials at the time. I was mainly doing grunt work, but it exposed me to an environment where people were extremely dedicated to their sciences and to doing something novel. I was exposed to the excitement that builds when people truly believe what they’re doing could revolutionize the way people are treated.

I’ve always felt a little bit like an outsider in an industry of people who belong here. While that may feel uncomfortable from time to time, it also affords me a unique perspective that others don’t have. While others in the industry tend to focus on vertical specialties, I’ve come to specialize in a macro view of this industry. My focus has been very horizontal, which gives me a perspective of the industry that not many people are able to see.

TLSR: What kind of work has RepliCel been doing in the cell therapy field?

RLB: When CEO and President David Hall took over the company in 2011, it was built around hair regeneration. That is still an important part of our portfolio; however, he had a vision for broadening the technology and building a platform, which the company has now executed.

We are preparing to launch a very significant Phase 2 trial using our RCH-01 (dermal sheath cup [DSC] cells) for hair regeneration. This is a cellular injection—a cell transplant rather than a hair transplant—and is an important evolution because hair transplant is limited by three very significant factors. First, when transplanting hair follicles from one location on your scalp to another, there are only so many follicles available to harvest. With a cell transplant, there is no limit to the number of cells we can grow to use in regenerating poorly functioning hair follicles. Second, hair transplantation only achieves a satisfactory result when performed by a gifted surgeon, of which there are few. A simple cell injection takes the art out of the procedure—particularly when combined with our proprietary injection device designed to optimally deliver the cells into the scalp. Finally, hair transplantation is not an option women find attractive for a number of reasons, and a significant population of women suffer from hair loss.

TLSR: How is RepliCel working to ensure this therapy will be effective in both the short and long term? What prevents the dermal sheath cells from ceasing to grow hair once they are in the locale where the original follicles quit producing hair?

RLB: The cells we are using to address pattern baldness (androgenetic alopecia) are taken from a cell population found at the base of the hair follicle. These DSC cells are used to produce our RCH-01 product. Research has demonstrated that these cells are responsible for the reorganization of the hair follicle, which is a mini-organ that organizes upon an unknown signal. Our research leads us to believe this cell population is responsible for hair regeneration.

We source our particular cells from hair follicles isolated from the back of the scalp, between the ears, because most balding people retain this area of hair. This hair is insensitive to the androgen hormone (DHT), which causes hair loss, making these hair follicles prime candidates for our hair regeneration product.

“We are preparing to launch a very significant Phase 2 trial using our RCH-01 (dermal sheath cup [DSC] cells) for hair regeneration.”

As to the question of whether this will be a durable response—how long the hair will last—this is one of several questions both we and Shiseido are targeting in our respective upcoming pattern baldness trials. We’re designing this next phase to look at dosing. We’re also looking at frequency of treatment: One cohort of the study gets a single treatment, another gets a second treatment at day 91.

But we’ll also be following these patients for a considerable length of time, to see whether the intended effects are maintained or whether they diminish over time. Even though there are only a proposed 160 participants, utilizing different dosing and different injection points throughout the scalp, there will be 396 treatment sites, or data points, that we will be able to gather from those 160 patients, in addition to the data to be gleaned and shared from the trial Shiseido is funding in Japan. These questions are great—effectiveness and duration of effect—and we have an obligation to answer them, which is why the trials are designed the way they are.

TLSR: What else is RepliCel working on at the moment?

RLB: We have another population of cells derived from the hair follicle (the non-bulbar dermal sheath cells [NBDS cells]) that we believe is a platform capable of generating multiple products for various indications. These cells can be readily expanded, and it turns out they are highly expressive of type 1 collagen. Our first trial with these cells will be using our RCT-01 product for the treatment of chronic Achilles tendinosis.

Up to 90% of healthy tendon is comprised of well-constructed type 1 collagen, and a number of indications manifest in patients due to the loss of type 1 collagen production in the endogenous cells, one of which is Achilles tendinosis. Tendons often are not well vascularized, and after a series of injuries and as a patient ages, the endogenous fibroblasts are exhausted of their ability to continue to produce the type 1 collagen necessary to support healthy tendons. RepliCel’s predicate science is built around the injection of autologous (harvested and administered back to the same patient) fibroblasts capable of producing the kind of collagen needed to restore the patient to healthier function and better pain scores.

TLSR: Do you have evidence of actual tendon regeneration?

RLB: In three tendinosis-related clinical trials performed using a similar cell type, which has now been licensed into the company, MRI imaging shows that tendon treated with this cell type was much more akin to healthy, young, functioning tendon than what the patients had prior to injection of cells. This is an exciting platform, and the company is about to launch a Phase 1/2 trial in chronic Achilles tendinosis. We believe the cells could also have application in other indications, including jumper’s knee, golfer’s elbow, tennis elbow and torn rotator cuffs, as well as in a number of dermatological applications. Late this year, we will launch a Phase 1 study in healthy volunteers to look at the ability to regenerate the underlying tissue of skin in patients who have aging or sun-damaged skin.

TLSR: Achilles tendinosis and androgenic alopecia are very different indications. Androgenic alopecia is a hormone-dependent condition, while Achilles tendinosis is trauma-related.

RLB: That’s a great point. Even though both of these studies—tendon repair and hair regeneration—use cells derived from the hair follicle, we’re working with two very different cell populations. As a result, they have the ability to elicit very different, targeted responses.

TLSR: RepliCel’s shares have suffered considerably over the past six months. What caused the dip and what is the company doing to fix the issue?

RLB: The fact of the matter is the company was delayed in progressing to its Phase 2 trial for RCH-01 in hair regeneration because of an issue with the supply of a critical growth media. The new media wasn’t producing the same results, so we had to go back to the drawing board and discover what the problem was. The comparability data is now coming in to support our belief that we’ve solved that problem. We have four trials expected to launch in the next few months (three of ours and one of Shiseido’s). Two of these are expected to give clinical readouts late next year. Until we are a company executing clinical trials, we are a company talking about executing clinical trials, and certain investors grow understandably impatient.

“We have another population of cells derived from the hair follicle that we believe is a platform capable of generating multiple products for various indications.”

I’m very pleased that in October we submitted an application to Health Canada for the proposed Phase 1/2 clinical trial for chronic Achilles tendinosis. This triggers a 30-day window during which Health Canada can provide a No Objection Letter allowing us to proceed with the trial. This event is the initial trigger for a cascade of catalysts anticipated over the following months related to this trial, as well as our proposed Phase 1 clinical trial in Germany for aging and sun-damaged skin, our proposed Phase 2 trial for pattern baldness (androgenetic alopecia) in Germany, and Shiseido’s upcoming trial for pattern baldness in Japan. We’ve been on the road for several weeks, crisscrossing the U.S., Canada and Japan, talking to investors, analysts and potential partners. We are pleased with the level of interest being generated, and believe that once we demonstrate we are executing on schedule, we will generate increased support.

TLSR: Is it possible that all these milestones will be met by the end of 2014?

RLB: We are working very hard to make that happen. I believe we’re on target to have our three clinical trial application filings submitted by year-end. We expect Shiseido to file its clinical trial application early in Q1/15.

We are, of course, dependent on regulatory clearance to initiate any trial, but we have had very active dialogues with the regulators overseeing all our proposed trials, and are submitting precisely what has been discussed. As mentioned, we have now filed the first of our three applications. The second trial application proposes to use a product (RCS-01) developed from the same platform technology, so the clinical-regulatory team can leverage much of the work already done to get the second application filed.

One thing to note is that the dermatology and tendinosis trials are relatively quick studies to enroll. We’ve been in constant dialogue with the principal investigators of the RCT-01 trial in chronic Achilles tendinosis, and they assure us there’s a pipeline of patients waiting to enroll in the study. The RCT-01 tendon trial is going to be a 28-participant study, and the RCS-01 in skin rejuvenation is a proposed 28-participant study design as well, but using healthy volunteers. The RCH-01 hair regeneration study is going to extend over a longer period of time, because it targets 160 participants. But the RCT-01 and RCS-01 studies will be relatively quick to enroll and to follow up on, and we expect data in 2015 for both of those.

Both of these studies are randomized, placebo-controlled and specifically designed to provide measurable and material biologic and mechanistic data that we will use to drive partner discussions. Remember that the company’s business model is to codevelop assets with partners who understand the markets and have proven commercialization capabilities.

We are excited about being in the position we are now in, poised to imminently execute on three clinical trials, finalize the development and validation of our propriety injection device (which has licensable applications for acellular injectables), capitalize on our partnership with Shiseido and the innovative regulatory pathway for regenerative medicines in Japan, which provides a window to early-market access for our pattern baldness treatment, and to execute on one or more additional licenses with codevelopment partners in the near term.

TLSR: Thank you very much for your insight, Lee.

RLB: Thank you.

R. Lee Buckler is vice president of business and corporate development with RepliCel Life Sciences Inc. Prior to working with RepliCel, he was the managing director of Cell Therapy Group, a firm he formed in 2008, where he did business development consulting for companies and organizations in or interested in the cell therapy sector. Buckler served six years as executive director of the International Society for Cellular Therapy, and just over two years as director of business development for Progenitor Cell Therapy. He is on the editorial advisory boards of the journal Regenerative Medicine and the BioProcess International magazine, as well as the co-chair of the Alliance for Regenerative Medicine’s Communications and Education Committee. Buckler cofounded Cell Therapy News, founded Cell Therapy Blog, cofounded Regenerative Medicine Jobs, founded and continues to manage the LinkedIn Cell Therapy Industry Group, and is an active industry commentator in publications and in social media. He serves on numerous industry conference advisory boards, is an advisory board member for BioCision and RoosterBio, and is on the board of directors for Hemostemix. He has a bachelor’s degree in education and a law degree.

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DISCLOSURE: 1) George S. Mack conducted this interview for Streetwise Reports LLC, publisher of The Gold Report, The Energy Report, The Life Sciences Report and The Mining Report, and provides services to Streetwise Reports as an independent contractor. He owns, or his family owns, shares of the company mentioned in this interview: None. 2) RepliCel Life Sciences Inc. paid Streetwise Reports to conduct, produce and distribute the interview 3) R. Lee Buckler had final approval of the content and is wholly responsible for the validity of the statements. Opinions expressed are the opinions of R. Lee Buckler and not of Streetwise Reports or its officers. 4) The interview does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. 5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their families are prohibited from making purchases and/or sales of those securities in the open market or otherwise during the up-to-four-week interval from the time of the interview until after it publishes.

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To listen to the full interview podcast and read the transcript click here: Midas Letter Interviews David Hall

Full Transcript:

James West: Let’s start off with an overview of exactly what the value proposition is for investors in RepliCel?

David Hall: RepliCel Life Sciences is an autologous cell therapy company that is developing treatments for aging and sun-damaged skin, chronic tendinosis…so any kind of tendon injury that people can imagine, and pattern baldness for males and females. I suppose the near-term catalytic investment proposition is that we’re within days of filing a clinical trial for chronic tendinosis in Canada, and that will be followed in a few weeks with a filing for a clinical trial in Europe for aging and sun-damaged skin, and then later on this year we’ll get into our Phase II trial for pattern baldness. So a lot of things happening.

James West: Yeah. That’s quite a broad mix of applications for one product. What is the essential technology? What is it all centered around?

David Hall: The technology comes from isolating specific cells from the human hair follicle. In the case of treating chronic tendinosis or sun-damaged skin, it all relates to a cell called a fibroblast, which we isolate from the sheath of a hair follicle, and these particular fibroblasts – which can also be isolated from other parts of the body – these particular fibroblasts are particularly proficient at producing type I collagen, which is the major substance structure of a tendon – it’s about 90% of the tendon – and of the skin itself. So in the case of a tendon, we’re healing that chronic wound, in the case of sun-damaged skin, we’re actually re-establishing the volume of fibroblasts in the dermis that produce the required proteins and type I collagen to give skin texture. So kind of like turning the clock back, if you will, for our aging and sun-damaged skin program.

James West: Interesting. Okay so how does RepliCel monetize this technology?

David Hall: It’s very straight forward. The company is designed to produce data on safety and efficacy, and take that data and go out and partner it. It is a platform technology where we can take our cells into other indications. Really if you demonstrate safety and efficacy in one fibroblast indication, for example, you’ll be able to take it into a bunch of other things like all of the different tendons, all of the different skin issues including scarring and acne, and burns and all sorts of issues with the skin, as well as things like periodontal disease which is a growing concern for health populations and health payers these days. And of course in terms of pattern baldness, we’ve already monetized it in the sense that we’ve licensed to Shiseido Corporation for Japan and Southeast Asia our cell treatment for pattern baldness, and they themselves are starting their own clinical trials in the not-to-distant future, so there’ll be two clinical trials developing dosing and frequency for that treatment. And once you get that kind of data, you can turn around and sell it for up-front payments for ongoing royalty payments, various sales milestones payments – so there’s lots of ways to monetize it. What we’re not doing is going out and building big factories and trying to build sales forces ourselves. The greatest value for the shareholder is actually to license this technology out at that sort of Phase II data point, of which we’ll get two sets of data next year that will be in that area.

James West: Okay so are you – is there substantial revenue at this point?

David Hall: Ah, no it’s a capital consumer like most biotech’s, although we did take a $4 million up-front payment from Shiseido, but that’s the nature of this game. You consume capital to a certain point in time, and then you produce data that says, well, this is now worth $100 million, $200 million, $300 million, $400 million – those are the kinds of metrics that you get in a biotech company. We know that for example on the derm side of the world, there’s already been one program approved for a company called Fibrocell (NASDAQ:FCSC) with respect to the smile lines in the face. So we know we can get approved through the FDA – that’s not a problem. And we think we have a much more prolific cell in terms of the fibroblast that we’re using. There are partnerships – lots of partnerships – that are coming into the regenerative medicine space. There’s market cap companies like Mesoblast Ltd. (ASX:MSB) (OTCMKTS:MBLTY) that’s over $1 billion, so there’s a vast array of market caps, but all of those examples as you get larger, all relate to delivering data, getting into clinics where there’s anticipation of data. It’s not unlike the junior oil and gas business, or a mining property, where there’s drilling, and you get that early evidence of an asset, and then you have to drill it out, and so we’re in the process of drilling it out, because we have that early asset. That’s probably a good analogy.

James West: Mm-hmm. Okay so let’s talk about that a bit. So analogous to what major market cap companies did you say that RepliCel is similar to?

David Hall: As I said, Fibrocell has a market cap around $100 million. They have a fibroblast treatment for the face – that’s one of our indications that we think we can improve on. There’s companies like Mesoblast Limited (ASX:MSB; USOTC:MBLTY) that are over $1 billion and they’re much more sophisticated – well not necessarily more sophisticated – they’re using bone marrow derived mesenchymal stem cells. We’re actually just using a target cell and we’re just making more of them. So we have a lower safety hurdle, but that’s an example of a company that is a leading one. And then there’s, other companies in between, like the Israeli company called Pluristem Therapeutics Inc. (NASDAQ:PSTI) – Nasdaq-listed, $200 million market cap, and they’re basically using placenta-derived stem cells. What we’re doing in contrast to all these other companies, is just simply taking a specific cell from the patient, and making more of them, and then moving them into the area where they’re required. So in the case of tendinosis, there’s a lack of these fibroblasts, and we can isolate really prolific fibroblasts, and replicate them and stick them directly into the wound.

The same concept as with the skin, or with a burn or with scarring acne. And with the case of pattern baldness, there is a specific cell that is missing in those people who are affected by androgen – it’s called a ‘dermal sheath cup cell’. We take androgen insensitive dermal sheath cup cells from the back of the head, replicate them and then inject them into the top to replenish a population of unhealthy dermal sheath cup cells to rejuvenate the hair follicle that’s been losing the thickness and the size of the fiber growth that comes from that hair follicle. So it’s really elegantly simple science, and it’s just a matter of us executing now, and that’s what we’re doing. We’re going into two clinical trials, our Japanese partner will start one later this year, so a lot of activity.

James West: Okay so let’s focus for a moment on the pattern baldness concept. I mean I would just think that if you came up with a cure, I mean a real cure, for pattern baldness that you would have yourself a very valuable company on your hands. Now has your strategy or your approach to pattern baldness been tested on human beings at this point?

David Hall:Yes. We actually did a 16 patient Phase 1 study, which is the basis of the data that we’re using for our Phase 2 study, as well as the data that’s being used by Shiseido Company in Japan to file for their trials. So in that safety trial that was 16 patients – only 16 data points – we had an average density growth in 6 months, which is all the trial went for in terms of the safety measurements – of 11.8%. Now, by contrast, the very best you get with the current drug therapies of Minoxidil or Rogaine – is about 16% and Finisteride, which is for Alapecia, is only about 14%. And those are over 12 months. So we know that we’re going in the right direction in terms of the density, and indeed about 70% of the responders were above 10%. And they averaged around almost 15%.

So we know we’re going in the right direction, and that was only with 16 patients. Now, the next step for us, is a 160-patient trial that will measure frequency and dosage. We need to determine if you have to give more than one injection to get a serial conversion of healthy hair follicles? And the other aspect is determining the best dosage so we will be testing three different doses. And that’s going to give us 390 data points versus the 16 that we had before, so we know we’ll have far greater data that will tell us what is the dose and what is the frequency, in order to treat somebody and get their hair follicles basically converted over to a population of androgen-insensitive cells. And androgen is the problem. No one knows why, but in some people androgen causes pattern baldness, and in some cases androgen causes people to have undesirable growth on different parts of their body. You know, it’s just how humans are. But we do know that the cells at the back of the head are completely androgen insensitive, and if you take those cells, replicate them, and put them up into the area of the pattern baldness, the goal is to let that population recruite into every hair follicle fiber cycle, and basically rejuvenate the population of cells that have been previously compromised by androgen. Again, very simple concept – now we just have to execute and figure out what dose, and what frequency.

James West: Yeah okay so is it looking to you like a complete cure? I mean so is a guy who’s bald as a cue ball going to be able to grow hair down to his butt? Is that what we’re talking about here?

David Hall: Yeah I mean that’s the point…based on the 16 patients that we tested, we were able to do a $35 million deal with Shiseido Corporation; $4 million up front, and $31 million in milestones and then ongoing royalties for Japan alone, and South Asia. So we really attracted a big company – they are the fourth biggest cosmetic company in the world – to the elegance of the science. And the outcome is yes – to simply change the outcome of pattern baldness. So if you think of yourself…the back of your head has hair follicles that produce fiber. The problem is that on the top of the head, over the years, your hair follicles, the cells called dermal sheath cups at the bottom of those hair follicles in the top of your head – they have been compromised by androgen. But the back of your head has hair follicles that are completely androgen insensitive, so we’re taking those cells – the cells from those follicles, it’s a single maybe two suture punch biopsy, and isolating those androgen-insensitive cells, and making them into millions, and then injecting them back up into the scalp. And every hair fibre cycle that you have causes the cells to turn over, and now we’re integrating these cells that are insensitive to androgen. So if we get the right dose, which is what we’re doing right now, and you have to get the right frequency, in other words do you have to take more than one injection – then the logical conclusion is that you get a complete serial conversion to a healthy hair follicle which you had when you were younger. And that’s kind of the goal. And it makes sense scientifically, but the challenge is you’ve got to figure out the dose and frequency, and that’s just a matter of trying.

James West: So the short answer to the original question then is ‘maybe’. Maybe this is a complete cure?

David Hall: Well if it works, then it’s a cure. I mean you no longer have cells that are affected by androgen running in your hair follicle on top of your head. So that is a permanent solution. It’s not like you’re taking a drug, which basically juices the performance of what cells are left, but it doesn’t actually change the inevitable outcome. We’re changing, we’re going to reverse and change the inevitable outcome, so those hair follicles no longer are compromised by androgen. That is the goal, and as I said it’s a matter of dose, and frequency that we’re trying to figure out between ourselves and Shiseido.

James West: Well that’s great…that’s a perfect first interview. We’re going to catch up with you in about another quarter and see how you’re making out. Thank you for joining us today.

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VANCOUVER, BC – October 2, 2014 – RepliCel Life Sciences Inc. (TSX.V: RP) (OTCQB: REPCF), clinical stage regenerative medicine company focused on the development of autologous cell therapies will be presenting at the Stem Cell Meeting on the Mesa Partnering Forum on Tuesday, October 7, 2014 at 11:45 a.m. local time in La Jolla Ballroom 2 at the Estancia La Jolla Hotel.

The presentation by Mr. David Hall, CEO, will include an update on RepliCel’s pending clinical trials for chronic Achilles tendinosis (RCT-A-01) and sun-damaged and aging skin (RCS-01) as well as its program for pattern hair loss (RCH-01). It will be webcast and posted on the conference website at http://stemcellmeetingonthemesa.com/webcast/, on RepliCel’s website at http://www.replicel.com/investors/corporate-publications/ and on the Alliance for Regenerative Medicine website, after the event, at http://alliancerm.org/ bringing tremendous exposure to the company.

“The Stem Cell meeting does an excellent job of bring together leading researchers, clinical experts, senior executives, health care investors and top decision-makers in the regenerative medicine industry. With nearly 800 attendees from around the globe, it is a great environment for discussions around partnerships, collaborations and investment,” commented David Hall, CEO of RepliCel.

Please visit http://stemcellmeetingonthemesa.com/ for full information on the conference including registration. Complimentary attendance at this event is available for credentialed investors and members of the media only.

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function. The company’s RCT-01, RCS-01 and RCH-01 cell therapies are designed to treat chronic tendinosis, damaged or aging skin, and pattern baldness. Shiseido Company, Limited has an exclusive license for RCH-01 in certain Asian countries including Japan, China and South Korea. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles. The company is also developing a propriety injection device optimized for the administration of its products and licensable for use with other dermatology applications. The company’s product pipeline is comprised of multiple clinical trials all anticipated to launch in late 2014 in addition to Shiseido’s own clinical trial of RCH-01 and the device in late prototype development. Visit www.replicel.com for additional information.

For more information please contact:

Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com
www.replicel.com

INVESTOR RELATIONS:
Christina Cameron, Investor Relations
christina@clcameron.com

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To view the article as it appears on Seeking Alpha, click here.

Summary

RepliCel is a rare blend of upside potential and risk mitigation.
The company has a multiple-product approach.
Near-term catalysts should make the stock pop.

While it is rare to find companies that offer a truly disproportionate positive risk-return profile, RepliCel Life Sciences (OTCQB:REPCF, RP.V) is positioned to have significant upside that is well-justified by the associated risks. The opportunity exists largely because the company is small and essentially unknown – its small size and low daily trading volume represent the most serious risk factors for investors to consider. As the company stands on the cusp of several catalytic events, however, RepliCel is positioned for a meaningful move that will benefit investors.

Who is RepliCel?

RepliCel is in the business of “treating cellular deficiencies” through its proprietary cell reproduction technology, specifically cases of tendonitis, pattern baldness and skin damage. Beyond the technology the company has developed to rapidly reproduce cells for its various treatment protocols, it has developed a delivery injector with addition potential applications. I recently had the opportunity to participate in a meeting directly with company president and CEO David Hall, who emphasized the importance of the diversified product portfolio that his company offers. Because RepliCel is diversified across the fibroblast (collagen-producing), dermal sheath cup (hair producing) and injector lines of business, Hall sees investor risk to be reduced as different lines move ahead.

Source: RepliCel Corporate Presentation August 2013

The general basis of RepliCel’s products is that the company harvest specific cells from the patient, and then uses its proprietary technology to replicate them in sufficient numbers to address the specific deficit. In the case of the tendonitis treatments, this involves creating new collagen cells that allow the damaged area to see improved function and reduced pain by altering the tendon’s basic construction. In the case of baldness treatment, healthy dermal sheath cells allow hair to grow in the needed areas. In both cases, the company’s injector is used to properly introduce the cells into the affected region. RepliCel’s method allows it to produce these cells much faster than competitors.

In early clinical testing, patient safety has been a top concern. In all Phase 1 trials thus far conducted, results were achieved within the required safety parameters. RepliCel is not involved in tradition stem cell therapies, making it less clinically and commercially risky. Part of what makes RepliCel unique, and particularly attractive from an investment standpoint, is that because the company is not using adult stem cells in its protocols, the regulatory burden falls on the low-end of the spectrum. The primary thrust of RepliCel’s treatments are in cosmetic and non-critical areas. While these do not tend to be of huge medical significance – although they can be – the revenue generating potential is there. This is one of the hallmarks of its current mandate to prove up its products to attract a buyer.

The fibroblast protocols have had statistically significant early results in treating various types of tendonitis (See below). In the Phase 1 trial, cell growth increases while pain decreased. Similar tests and Phase 2 testing are moving ahead for tendonitis in the elbow as well. This same technology is moving to Phase 1 trials for treating skin damaged by aging, UV exposure and lifestyle factors. Ultimately, each of these conditions alone represent a significant advance against currently available options, and are in sizeable markets.

Source: RepliCel Corporate Presentation August 2013

Improved Baldness Treatment

In terms of the company’s baldness treatment, Phase 1 showed positive results in less time than the currently available options. While micro-transplant surgery is the current gold standard – it is expensive and highly dependent on the surgeon – Rogaine and Propecia are the most commonly used options currently. Rogaine has shown 8%-16% density increases over 12 months with topical treatment, and Propecia has shown 7%-14% increases over 12 months with an oral regimen. The Phase 1 RepliCel treatment showed an average 11.3% density gain, with 70% achieving over a 10% gain, with the over 10% group averaging 14.3%. The most significant difference with the RepliCel protocol is the end point. Where Rogaine and Propecia require continued use to maintain gains, after the RepliCel injections, gains remain in place. This is a significant point of differentiation.

Catalysts

A highlight for RepliCel from the investment prospective is that the management team is keenly focused on building shareholder value. Hall is targeting and projecting a takeout scenario within 24 months, with major catalysts building value on that path. The biggest driving factor there is new results from the ongoing clinical trials. As each sets a small step-up for the company in terms of the development of a fully saleable product, share price should be significantly impacted.

Along this path, RepliCel already has a key partnership in place with Shiseido, the fourth-largest cosmetics company in the world. The agreement, inked in 2013, provided RepliCel with $35 million, with $4 million upfront and additional fundings at key sales targets. Beyond the capital, Shiseido has built a new cell processing facility that opened in May 2014. The company represents a key strategic partner in terms of both financial strength and reputation. Additionally, this allegiance will allow RepliCel to move quickly in the region as trials for U.S. sales continue. RepliCel continues to seek new partners for other products, each of which, when identified, can serve as a catalyst.

In the near term, there are three different clinical trials beginning in 2014 that should yield the type of data results needed to see the stock move dramatically higher. For example, the planned Phase 2 study on pattern baldness will use a larger test group to establish the lasting efficacy of the treatment, confirming both the safety and effective end date relative to other options. As each of these steps move ahead, RepliCel is well-positioned to move. Hall reports that the company has plenty of cash to complete the clinical trials that are currently planned. He believes that the positive results expected from these will be sufficient to generate the buying interest needed, placing a takeout target within the next 24 months.

The Stock

A definite risk factor of the stock is the very low average trading volume (ADV) of shares. Between shares listed in the U.S. and on the Canadian Venture Exchange, the stock trades less than 100,000 shares per day. This means that the liquidity of any position must be a consideration for any investor making a larger play in the stock. On the other side of things, however, shares are near the bottom of the 52-week trading range. This means that a retracement of even 50% back to that high would represent a dramatic return.

Given the price of shares relative to the potential upside, I believe RepliCel offer an attractive risk-adjusted opportunity to shareholders. There are several catalysts tied to near-term expected milestones that should make the stock move higher. If management can achieve its ultimate goal of a takeout opportunity, shareholders will be well-rewarded. The liquidity risk is real, but the potential here justifies taking some risk.

Editor’s Note: This article covers one or more stocks trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.

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RepliCel’s Innovative Technology Converts Your Own Cells into Products to Repair and Rejuvenate the Body

VANCOUVER, BC – September 9, 2014 – RepliCel Life Sciences Inc.’s (TSXV: RP) (OTCQB: REPCF) CEO, David Hall, kicked-off his New York roadshow with a live appearance on Fox Business network’s Varney & Co. following his presentation at Rodman & Renshaw’s Annual Global Investment Conference. The two discussed the company’s revolutionary products using an individual’s own cells to treat sports and work related tendon injuries, sun damaged and aging skin and pattern baldness. The interview can be viewed online at http://www.foxbusiness.com/on-air/varney-co/index.html#/v/3775771951001.

In addition to the U.S. coverage, Canada’s Financial Post featured a full page editorial on RepliCel in today’s biotechnology section (see page FP12). The article titled, “Cutting-edge advancements – new technology puts your own cells to work to repair and rejuvenate your body” can be viewed online at http://business.financialpost.com/2014/09/09/new-technology-puts-your-own-cells-to-work-to-repair-and-rejuvenate-your-body/.

“We are happy to be called upon by the media and the investment community to discuss the advancements being made in regenerative medicine. Cell therapy products like RepliCel’s represent a new way to repair and rejuvenate patients effected by aging and injury. In the months ahead, RepliCel will be fully engaged with three clinical trials targeting chronic tendinosis, sun damaged and aging skin and hair loss in addition to a parallel trial anticipated to launch by its partner, Shiseido. Data from these trials will help pave the way for other RepliCel products targeting diseases and conditions associated with a deficit of healthy functioning cells,” commented David Hall, CEO of RepliCel.

Mr. Hall’s 20 minute presentation from the Rodman & Renshaw conference was webcast, and can be viewed at http://www.wsw.com/webcast/rrshq24/repcf/.

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function. The company’s RCT-01, RCS-01, and RCH-01 cell therapies are designed to treat chronic tendinosis, damaged or aging skin, and pattern baldness. Shiseido Company, Limited has an exclusive license for RCH-01 in certain Asian countries including Japan, China and South Korea. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles. The company is also developing a propriety injection device optimized for the administration of its products and licensable for use with other dermatology applications. The company’s product pipeline is comprised of multiple clinical trials all anticipated to launch in late 2014 in addition to Shiseido’s own clinical trial of RCH-01 and the device in late prototype development. Visit www.replicel.com for additional information.

CORPORATE CONTACT:
David M. Hall, Chief Executive Officer
Tammey George, Director of Communications
RepliCel Life Sciences
604-248-8696
tg@replicel.com

INVESTOR RELATIONS:
Christina Cameron, Investor Relations
christina@clcameron.com

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To read the full report click here: RepliCel’s Cutting-Edge Advancements

The following has been published in the Financial Post:

There is enormous interest in the worlds of medicine and esthetics in the promise of regenerative medicine. From cellular replacement techniques for treating Parkinson’s disease to collagen-producing cell injections for wound healing and rejuvenating aging skin, significant steps are being made towards the commercialization of cell therapies. These changes are going to attract major industry players who are constantly on the watch for the latest technologies in development.

Vancouver-based RepliCel Life Sciences Inc. (TSX.V: RP) is a company that is already capturing industry attention. Its unique research into cells from hair follicles could play an integral part in accelerating the repair of tendons, damaged skin and pattern baldness.

David Hall, chief executive officer of RepliCel, describes the premise behind its research as being “elegant in its simplicity.” For example, to treat chronically injured tendons, a patient’s collagen-producing cells (fibroblasts) are isolated from a small biopsy taken from the nape of the patient’s neck, replicated and then injected directly into a damaged tendon to stimulate the stalled healing process leading to structural rehabilitation.

“These isolated fibroblast cells are prolific in their ability to produce Type 1 collagen, the key and missing cell in the stalled healing cycle of a tendon. This same principle holds for aged and sun-damaged skin where the collagen-producing fibroblasts have been damaged by ultraviolet light over time. Our focus is to address indications where there is a deficit of active fibroblasts,” Hall explains. “As injuries occur and people age, their ability to produce collagen and other critical proteins is depleted through repeated injury, sun damage, aging and other factors. Our technology, as it’s proposed, will jump-start the healing process.”

One focus for RepliCel is on clinical trials for chronic tendon injuries, an area of major concern for employers, compensation boards, athletes, active aging populations and the military. Early clinical work using cells isolated from the skin returned excellent results, and RepliCel believes that it has improved the technology even further by using healthier cells isolated from hair follicles. Trials planned for the fall of 2014 will return results in 2015.

The power of the RepliCel approach lies in the fact that treatment utilizes a person’s own cells, thereby reducing risk of complications, notes Lee Buckler, managing director for Cell Therapy Group, a Vancouver-based regenerative industry consulting company. “Taking a patient’s own cells, replicating them in a regulated facility and then returning them to the body minimizes safety risks.”

The markets RepliCel is addressing with their products are significant, he adds. “Their platform, built around two different hair follicle cell populations, could be instrumental in skin applications for burns, acne scarring or aging, in addition to the market for musculoskeletal injuries. It could also play a key role in disrupting the micro-transplant and hair rejuvenation business for pattern baldness.”

Regenerative medicine technologies are now solidly on the radar of big pharmaceutical, biotech and health care companies, Buckler says. “Most life science company executives now believe that cell-based products will represent a new way of delivering therapies to patients. As such, they’re now starting to invest in technologies to make sure they have a horse in the race.”

“Most of the top companies like Pfizer, Janssen, GSK, Novartis, Celgene now have internal and/or external cell therapy programs,” Buckler adds. “Other companies are investing in bringing manufacturing technologies to the sector and even companies not traditionally in health care, like Nestlé and L’Oreal, have established their own research institutes for these cell-based programs. If you look at the industry’s development pipeline, most every condition is being pursued as a target for a cell therapy.”

RepliCel’s current pipeline includes trials for tendinosis, pattern baldness and treatments for aging and sun-damaged skin in various stages of development. Hall estimates that data from the tendon and dermal programs will be available to support licensing discussions by 2015, and pattern baldness in 2016.

“Having this many trials is pretty impressive for a small company,” Hall says. “Our model has always been to develop products, demonstrate efficacy and then license to large pharma or cosmetics firms who can do the final commercialization. We want to be the research and development engine that creates revenues from licences and royalties. In fact, Shiseido Company of Japan has already partnered with us on our pattern baldness product. They acquired an exclusive geographic license for Asia.”

Having spent much of his career researching treatments for tendinosis, Dr. Jack Taunton, professor at the University of British Columbia faculty of medicine’s sports medicine division, says regenerative therapy holds great promise when dealing with chronic, long-term injuries. “We’ve dealt with a number of these types of injuries caused by overuse or repetitive strain in thousands of patients. Typically treatments have included physiotherapy, ice, anti-inflammatory’s, dextrose and PRP [platelet-rich plasma] injections. Yet, we still have a significant population of patients that do not get better.” He is hopeful that the upcoming RepliCel trials will improve those numbers given that hair follicle fibroblasts produce the amount of Type 1 collagen needed for fundamental repair of the tendon. “The potential to save millions of dollars in treatment of chronic tendon disorders is huge. It’s extremely exciting.”

Dr. Ross Davidson, an orthopedic surgeon and director of post-graduate sports medicine at the University of Auckland in New Zealand has treated countless athletes with chronic overuse injuries throughout his career. “I do see a huge potential for this. It has been a pleasant surprise to see the amount of collagen these fibroblasts produce for repairing tendons. It’s a big change from other treatments being released. If it works — and I believe it will — it will reduce the number of surgeries significantly.”

Beyond its clinical trials, the success of RepliCel’s products will be put in the hands of licensing partners which have the infrastructure to support commercialization, says Mark Landy, director of research for senior medical technology and regenerative medicine analyst for Summer Street Research in Boston. The good news is that the industry is not having to wait too long for the clinical trials to get proof of concept. “Having data coming in 2015 and 2016 enables the company to accelerate licensing.”

He believes RepliCel has a significant opportunity ahead given that its regenerative therapy approach addresses extremely large markets that are ready for solutions not provided by today`s treatments. “The industry as a whole has gone beyond the fears around regenerative and genetic engineering and is seeing its value. We now know we can take certain cells from the body and safely put them in certain areas. It’s a notion that goes back to bone marrow transplants and implants. The opportunities — and the markets — for regenerative medicine are very, very large.”

With results from clinical trials on the horizon, Hall is confident things are moving forward as they should. “We’ve been quietly building the fundamentals of this business – forging deals with major players, building up a diversified portfolio and strengthening our management team. Every step we take is incrementally adding value to the shareholders and furthering therapies for patients.”

hopeful that the upcoming RepliCel trials will improve those numbers given that hair follicle fibroblasts produce the amount of Type 1 collagen needed for fundamental repair of the tendon. “The potential to save millions of dollars in treatment of chronic tendon disorders is huge. It’s extremely exciting.”

This story was produced by Postmedia’s advertising department on behalf of Market One Media Group for commercial purposes. Postmedia’s editorial departments had no involvement in the creation of this content.

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The information in these press releases is historical in nature, has not been updated, and is current only to the date indicated in the particular press release. This information may no longer be accurate and therefore you should not rely on the information contained in these press releases. To the extent permitted by law, RepliCel Life Sciences Inc. and its employees, agents and consultants exclude all liability for any loss or damage arising from the use of, or reliance on, any such information, whether or not caused by any negligent act or omission.

THIRD PARTY CONTENT
Please note that any opinion, estimates or forecasts made by the authors of these statements are theirs alone and do not represent opinions, forecasts or predictions of RepliCel Life Sciences Inc. or its management. RepliCel Life Sciences Inc. does not, by its reference or distribution of these links imply its endorsement of, or concurrence with, such information, conclusions or recommendations.