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Jul 15, 2015 {
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"Description": "Clinical research organization, Accerise Inc., has been retained to work with RepliCel and its other service providers to prepare study documentation, plans, and approvals for clinical evaluation by multiple clinical sites in Japan
VANCOUVER, BC, CANADA – 19 May 2021 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, is pleased to announce that it has retained leading clinical research organization, Accerise Inc, with offices in Tokyo and Osaka, to lead the planning and preparations for clinical research studies of RepliCel’s skin rejuvenation (RCS-01) and tendon regeneration (RCT-01) cell therapy products in Japan.
Accerise will support RepliCel’s clinical advisors, Professor Morita and Professor Kumai, in the design of the clinical study protocols, procuring the collaboration of all clinical sites, obtaining all necessary approvals from institutional research boards (IRBs), oversight committees, and the Ministry of Health, Labour and Welfare (MHLW) including certification, training, and the establishment of the necessary systems for independent clinical study management to ensure the studies produce high-quality GCP-compliant data. This will also include certification of RepliCel’s contract manufacture for the manufacture of RepliCel’s cell therapy products for use in these clinical studies.
Both cell therapies have been the subject of successful phase 1 studies in Germany and Canada. The next-phase clinical research studies in Japan will be conducted under that country’s Act for Safety of Regenerative Medicine (ASRM) and, upon successfully meeting its endpoints, could lead to a commercial launch of the products in Japan.
About Accerise, Inc
ACCERISE was established in 2004 and provides comprehensive support for clinical development in Japan including planning of development strategies, GAP analysis prior to development in Japan, PMDA consultation, clinical trial management, and regulatory approval applications. Also, the company operates CRA dispatch and professional recruitment services that meet clients’ needs. ACCERISE set up a joint venture with Hangzhou Tigermed Consulting Co., Ltd. in 2020 and are also focusing on clinical development support in Asia. https://accerise.co.jp/english/
About RepliCel’s First-in-Japan Strategy
RepliCel was one of the first foreign regenerative medicine companies to have a Japanese partnership in 2013. In 2015 RepliCel was one of the first foreign regenerative medicine companies to initiate a consultation process, under the new regulations for regenerative medicine products, with Japan’s PMDA (Pharmaceuticals and Medical Device Agency). In 2016, RepliCel’s licensee, Shiseido Company, was one of the first companies to fund and manufacture a product for use in a clinical study under the newly legislated Act for the Safety of Regenerative Medicine (ASRM).
RepliCel aims to be one of the first foreign regenerative medicine companies based outside of Asia to directly engage in a clinical study of a cell therapy product under the ASRM regulatory pathway to commercialization. RepliCel will also be one of the first such companies to apply for certification of a manufacturing facility outside of Asia for the production of a cell therapy product to be imported for use in a clinical study governed by the ASRM regulations.
About RepliCel's Programs in Japan
RepliCel is currently preparing for the clinical testing and commercialization of three additional technologies in Japan. These include two cell therapies - one for skin rejuvenation and one for tendon regeneration - and a next-generation dermal injector for aesthetic treatments involving a wide variety of injectable substances including cells, PRP, muscle paralysis toxins, fillers, enzymes, drugs, other biologics, etc.
The RepliCel cell therapy technology which is the subject of active, ongoing partnership discussions in Japan has already been the subject of two successfully completed consultations with Japan's Pharmaceutical and Medical Devices Agency (PMDA). Planning for clinical research studies under Japan's Act for the Safety of Regenerative Medicines (ASRM) is already underway. Manufacturing of the clinical product will be performed by a Japanese-owned contract manufacturer preparing now for PMDA-certification under Japan's Ministry of Health, Labour, and Welfare (MHLW) applicable guidelines. Conduct of the clinical research studies will be managed by a high-quality Japanese clinical research organization.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.
The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is exclusively licensed in Asia to Shiseido Company. RepliCel maintains the rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.
RepliCel has also developed a proprietary injection device, RCI-02, and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the RCI-02 device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being approved for market launch in either the United States or Europe.
Please visit www.replicel.com for additional information.
Notable Facts:
• RepliCel's three cell therapy products have now been tested in over 100 patients in four countries on three continents having been successfully reviewed by three regulatory agencies.
• RepliCel now has key strategic partners in the United States, China, and Japan each of which is now investing heavily in the further clinical testing and development of RepliCel's products for their markets. Data from each of the clinical programs will strengthen the product development initiatives for RepliCel and its other partners worldwide.
For more information, please contact:
Lee Buckler, CEO and President
info@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.
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Another cell therapy rising star, RepliCel Life Sciences, is harnessing the healing properties of hair follicles to address unmet medical needs in acute, chronic and genetic conditions. RepliCel’s product pipeline features a diverse portfolio spanning tendinopathies, pattern baldness, skin damage, and dermal injector medical devices.
READ FULL ARTICLE
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"Description": "Company Uses Patients' Own Cells To Put An End To Baldness, Aging Skin And Tendon Degeneration
By Robin Seaton Jefferson
Forbes Magazine. September 29, 2017.
Hollywood has made movies about it. Industries have made billions from it. And if the volume of scripture is any indication, the Almighty God must have placed great value on his creation of the head of human hair. After all, He gave Samson—the strongest man of whom the Bible tells—his immense strength through his hair and declared a woman’s hair \"a glory unto\" her in the 11th chapter of 1 Chorinthians.
Is it any wonder men and women obsess over their hair? And though we may get wiser as we age (a good thing), most of us don’t get hairier—at least not in the places we want to (not a good thing).
But there is a Canadian company who has been working diligently to change that.
To read the full article, please go to the Forbes Magazine article.
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"Description": "First-in-human clinical study meets primary endpoint demonstrating product safety and clinical potential for tendon regeneration and healing
VANCOUVER, BC – March 28, 2017 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”) is pleased to report compelling safety and clinical data from its phase 1/2 tendon repair study investigating the use of RepliCel’s type 1 collagen-expressing, hair follicle-derived fibroblasts (RCT-01) as a treatment for Achilles tendinosis.
The clinical trial met its goal of establishing a complete safety profile at 6 months and showed no serious adverse events related to the study treatment or injection procedure.
Additionally, each of the treated participants, all of whom suffered chronic tendon pain and loss of function over an extended period of time with no recovery from standard treatments, showed numerous clinically important improvements by various measures including tendon composition, blood supply, physical function and pain sensation.
“Chronic tendinosis is a state of tendon degeneration that is very difficult to reverse, as evidenced by the many therapies used to try and treat it,” stated Dr. Ross Davidson, an orthopedic surgeon, former clinical professor at the Department of Orthopaedics at the University of British Columbia, and past head physician and orthopaedic consultant for the Vancouver Canucks (of the National Hockey League (NHL)).
“This study shows exciting clinical improvements in patients with clinically diagnosed chronic Achilles tendinosis who were unresponsive to standard treatments, and who had suffered for many months (in some cases, years) with frequent pain and loss of function. Not only did the study show several clinically important improvements in pain and function scores, but several ultrasound measures clearly demonstrate a marked improvement in tendon structure; something rarely seen in patients with this condition,” said Davidson.
“With further clinical studies, this new technology could represent a cutting-edge advancement in kick-starting a healing process that results in tendon regeneration. For the first time, we may have a treatment that shows signs of reversing the underlying problem, versus just treating the symptoms. This could be a game-changer in sports medicine,” Dr. Davidson concluded.
The most clinically material improvements observed from the study are summarized as follows:
VISA-A Scale of Achilles Tendon Injury Severity
Participants treated with RCT-01 in the per protocol population who completed the VISA-A evaluation 6 months after receipt of injections showed clinically relevant signals of healing including an overall 15.3% improvement in total score compared to baseline. Two patients showed select measures of near-complete recovery in function (by VISA-A scoring).
VAS Scale of Pain Severity
Four out of five participants treated with RCT-01 who completed questionnaires 6 months after injection showed clinically relevant signals of improvement in pain on loading (running/jumping) based on VAS score. Average improvement in VAS score for the four participants was 62.9% over baseline VAS score.
Three out of five participants treated with RCT-01 who completed questionnaires 6 months after injection showed improvement in pain on palpation based on VAS score. Average improvement in VAS score for the three participants was 55.2% over baseline VAS score.
Two patients showed select measures of near-complete elimination of pain (by VAS scoring).
“This trial was to show the safety of injection of hair follicle-derived non-bulbar dermal sheath cells (NBDS),” stated RepliCel’s Chief Medical Officer, Dr. Rolf Hoffman, “as well as to repeat the landmark trials of our collaborators who injected skin-derived fibroblasts together with PRP (platelet-rich plasma) in different tendinopathies. We believe the cause of healing (mechanism of action) in those studies was the cellular collagen production and not the PRP which, in our view, has little clinical or commercial potential as a therapeutic product or treatment for tendon repair.”
“I am very pleased that in this trial we see some early signals of regenerative healing in some patients and because of its similar pathogenesis, there is every reason to believe the ability to heal Achilles tendons will extend to numerous applications including repairing the patellar tendon of the knee (jumper’s knee), both tendons of elbow (tennis elbow, golfer’s elbow), and the rotator cuff,” observed Dr. Hoffmann. “Furthermore,” he concluded, “when we have established that our cell therapy heals chronic tendon injury, it may then be used by physicians for more acute injury with the goal of an approved label for these additional treatments in the future.”
“This is a major step forward in the Company’s development of a series of products which leverage the exciting collagen-producing capacity of these cells,” stated RepliCel CEO, Lee Buckler. “Our management and clinical team are very excited about the data from this trial and the potential for further development and clinical testing of this product to treat patients without good options for the tendon degeneration, pain and loss of function they are experiencing.”
Buckler concluded: “We have captured the medical and investment communities’ attention and see the results of this much anticipated, proof-of-concept clinical study as an opportunity to advance therapies for patients and incrementally add value for shareholders in the months ahead.”
About Achilles Tendinopathy
Achilles tendinopathy is a condition that causes pain, swelling and stiffness of the Achilles tendon that joins your heel bone to your calf muscles. It is thought to be caused by repeated tiny injuries to the Achilles tendon. These may occur for a number of reasons, including overuse of the tendon; for example, in runners. Treatments range from physiotherapy, to anti-inflammatory medications, to surgery. For many people, symptoms of Achilles tendon injury usually clear within three to six months of starting treatment. However, for some people the injury does not respond to treatment and progresses to chronic tendinosis. There is an estimated incidence rate of 656,211 new cases of mid-portion Achilles tendinopathy each year in North America alone, according to statistics published in the British Journal of Sports Medicine.
About the RCT-01 Tendon Repair Study
The study was designed to demonstrate the safety of a single injection of RepliCel’s RCT-01 into the Achilles tendon. While the study was not designed to be statistically significant for efficacy, multiple measures of efficacy were incorporated to give insights into the product’s potential and to assist in guiding future development decisions. Measures of whether the product may be working included testing and scoring patient pain in various settings, evaluating overall function, blood flow changes in the tendon, and changes in the overall density and composition of the tendon as measured by ultrasound imaging. For further trial details see: https://www.clinicaltrials.gov/ct2/show/NCT02330146.
The first-in-human study involved patients clinically diagnosed with chronic Achilles tendinosis. The primary purpose of this single-centre, phase 1/2 randomized (3:1), double blind, placebo-controlled trial was to assess the safety profile of RCT-01 injections, as compared to placebo injections. The study also measured the potential efficacy and impact injections had on tendon structure and function and the symptoms of Achilles tendinosis. The study was led by principal investigator Dr. Rob Lloyd-Smith, MDCM of the University of British Columbia (UBC) and was conducted at the UBC Sports Medicine Clinic in Vancouver, BC, Canada. Data from such a trial, not designed for statistical significance, often signals clinically significance, which is extremely informative for future product development and clinical trial design. The goal of the study was to establish sufficient evidence of safety to allow the Company to proceed with well-powered phase 2 studies investigating optimal dosing, treatment frequency, effect duration, etc.
As was expected with injecting 1.5mL into the Achilles tendon, all study participants who received injections (less one RCT-01-injected participant) reported at least one adverse event related to treatment regardless of treatment administered (RCT-01 or placebo). The adverse events were either soreness at the injection site or the observation of a partial thickness tear in the tendon post-injection. Most reports of soreness resolved shortly after receiving injections.
About Tendon Treatment Clinical Efficacy Measurements
VISA-A
The VISA-A scale aims to evaluate the clinical severity for patients with chronic Achilles tendinopathy. It is a questionnaire which evaluates symptoms and their effect on physical activity. It can be used to compare different populations with chronic Achilles tendinopathy and facilitate comparisons between studies. It can be used to determine the patient’s clinical severity. The VISA-A represents a clinically validated, reliable and disease-specific questionnaire to measure the condition of the Achilles tendon, but it is not a diagnostic tool. The final version of the questionnaire was named the Victorian Institute of Sport Assessment-Achilles Questionnaire.
VAS
A Visual Analogue Scale (VAS) is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. It is an instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. From the patient’s perspective, this spectrum appears on a continuum, in that their pain does not take discrete jumps, as a categorization of none, mild, moderate and severe would suggest. It was to capture this idea of an underlying continuum that the VAS was devised.
About Dr. Ross Davidson
Dr. Davidson is the former Director, Post Graduate Programmes in Sports Medicine at the University of Auckland, and a member of the New Zealand Orthopaedic Association and the Canadian Orthopaedic Association. He is the past president of the National Hockey League Physicians Society, past head physician and orthopaedic consultant for the Vancouver Canucks Hockey Club (NHL), past orthopaedic consultant to the Vancouver Grizzlies Basketball Team (NBA), past orthopaedic consultant to Allan McGavin Sports Medicine Centre, and past orthopaedic consultant to the Canadian Football League Players Association. Dr. Davidson held the position of clinical professor, department of orthopaedics at the University of British Columbia until 2000.
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 tissue healing and function. The Company’s product pipeline is comprised of three clinical-stage products: RCT-01 for tendon repair, RCS-01 for skin rejuvenation and RCH-01 hair restoration. RCH-01 is 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. RepliCel 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 http://replicel.com/ for additional information.
For more information, please contact:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com
Forward-looking information
This press release contains forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding (i) that RCT-01 has the ability to heal Achilles tendons, (ii) that RCT-01 will extend to numerous applications including repairing the patellar tendon of the knee (jumper’s knee), both tendons of elbow (tennis elbow, golfer’s elbow), and the rotator cuff, (ii) that the results of this clinical study will act as an opportunity to advance therapies for patients and incrementally add value for shareholders over the months ahead.
These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements, including: the risk that there will be delays enrolling clinical trial participants; the risk that the Company will receive negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with future approvals for clinical trials; risks associated with the Company obtaining approval for its clinical trial in Germany; risks associated with the Company obtaining all necessary regulatory approvals for its various programs in Canada, the USA and Germany; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties in connection with the outstanding issues alleged by Shiseido in connection with the License and Co-development Agreement; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2015 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.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.
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"Description": "To read the full article as it appears on The Huffington Post, click here. (1/20/17)
While 2016 may not go down as a lot of people’s favorite year, one development most people will agree to put a positive checkmark beside is the near-unanimous passing of the 21st Century Cures Act in the United States.
In the last breaths of its tenure, the Obama Administration was able to bring both sides of Congress, the patient community and industry lobbyists together in a consensus on what was needed to drive better, faster medical innovation in the years to come. Faster cures to future patients.
There are a lot of reasons to be pleased with the many provisions of the 21st Century Cures Act but as the CEO of a cell therapy company, RepliCel Life Sciences Inc., I’ll focus this brief post on the area in which I’ve dedicated most of my professional life.
Out of the spotlight of the more prominent provisions of the Act, is a section pertaining to what I predict will be a growing but eventually radical boost to the development of regenerative medicines such as “cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products”.
Regenerative medicine is the idea that we can use cells or tissue from a patient or donor and do something more therapeutically significant for patients suffering from disease or conditions than we can do with drugs or other therapies. This next pillar of medicine dares to cure not just slow disease progression or reduce symptoms.
The 21st Century Cures Act promises not only foster the development of such therapeutic products but presents, I believe, exciting reasons to re-look at investing in cell therapy and other regenerative medicine companies. Here are four such reasons:
1. The Act clearly establishes this emerging sector of cell therapies and other regenerative medicines as an official part of the bio-pharmaceutical industry and the future of healthcare in America.
2. The Act provides for any product designated as a “regenerative advanced therapy” to be the beneficiary of ‘priority review’ by the FDA.
3. The Act mandates the FDA to define a pathway for ‘accelerated approval’ for products designated as ‘regenerative advanced therapies’.
Why does this radically change the investment thesis for cell therapy and regenerative medicine companies? It is almost impossible to imagine how ‘accelerated approval’ does not translate somehow into provisions that mimic conditional approval such as those implemented in Japan a couple years ago. While there will almost certainly be stringent post-marketing and/or patient registry obligations, this translates inevitably into a shorter clinical development pathway resulting in regenerative medicine products getting faster-to-market and the companies quicker-to-revenue. This shortens the return-on-investment window for those companies developing products likely to be eligible for the ‘regenerative advanced therapy’ designation.
4. The Act drives a further wedge between the ‘stem cell clinics’ providing ill-defined treatments with inadequate evidence that they work and the companies investing in regulated clinical trials and developing well-defined products. To the extent that patients and/or investors are confused by the distinction between such clinics and companies developing regulated products, the Act provides yet another piece of clarity and direction that Congress and the FDA will continue to step up efforts to ensure cell therapies are regulated and both patients and investments are protected from unregulated competition.
As larger-cap cell therapy companies such as Juno Therapeutics and Kite Pharma race for FDA market approval in 2017 based on relatively small phase 2 data, it is a prime opportunity for smart investors to look at the wave of cell therapy companies in the micro or nano-cap categories. I’m excited about what we’re doing at RepliCel Life Sciences with cell therapies for chronic tendon injury, pattern baldness and anti-aging of the skin and the series of clinical data announcements we have in early 2017 but there are a number of similarly exciting regenerative medicine companies worth attention (see, for example, the website of the Alliance for Regenerative Medicine, as a great resource for finding such companies).
Here’s to an exciting year for cell therapy companies, investors, products and – most importantly – the patients who will benefit from our daring to develop regenerative medicine cures.
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"Description": "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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"Description": "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
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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"Description": "Canadian companies driving global breakthroughs in regenerative medicine
By Kathryn Boothby
To read this article on the Financial Post website, click here.
![](\"/Blog/2015/Replicel-FP_illustration_300dpi-e1445888122639.jpg\")
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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![](\"/Blog/2015/DermalInjector.jpg\")
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?
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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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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.
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