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Jan 15, 2017 - RepliCel's three cell therapy products have now been tested in over 100 patients in four countries on three continents.
- RepliCel now has key strategic partners in the United States, China, and Japan each of which are 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
604-248-8693
Clinical Data Published from RepliCel’s Skin Rejuvenation Study
A paper entitled, “Autologous Cell Therapy for Aged Human Skin: A Randomized, Placebo-Controlled, Phase-I Study”, has been published summarizing the data from RepliCel’s clinical trial of RCS-01
VANCOUVER, BC, CANADA – September 24, 2019 – 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 the publication of clinical data from its skin rejuvenation study (RCS-01) in an article entitled, Autologous Cell Therapy for Aged Human Skin: A Randomized, Placebo-Controlled, Phase-I Study, published in the peer-reviewed journal Skin Pharmacology and Physiology (Skin Pharmacol Physiol http://dx.doi.org/10.1159/000502240).
The publication summarizes data from a clinical trial in which it was shown that RepliCel’s RCS-01 injections are well-tolerated for up to one-year post-injection and therefore safe to use. The study also demonstrated how the injections might reverse the effects of aging skin. As summarized in the paper, the study clearly established a biological link between RCS-01 injections and changes in the expression of particular genes in the skin. These changes in gene expression are expected to be indicative of the potential for rejuvenation of the extra-cellular matrix (ECM) under the dermis that is so important to vibrant, youthful skin.
“We are very pleased that the esteemed, peer-reviewed journal, Skin Pharmacology and Physiology saw the merit of RepliCel’s clinical work,“ stated RepliCel President & CEO, R. Lee Buckler, “and the potential of our proprietary cell therapy, RCS-01, for skin rejuvenation.”
The publication presents data showing for the first time that injections of NBDS-derived autologous cells into the human skin dermis layer alters the transcriptional expression profile of genes, which are involved in ECM homeostasis. Specifically, in comparison to placebo-treated skin areas, injection of NBDS-derived fibroblasts promoted the expression of the genes TGFbeta1, CTGF, COL1A1, COL1A2, COL3A1, and lumican. These genes encode for proteins which are important for ECM homeostasis, thought to be of pathogenetic relevance for skin aging. In aged skin, levels of type 1 and type 3 collagen precursors and crosslinks are reduced.
The observation that injection of NBDS-derived cells is associated with an increased transcriptional expression of these genes indicates the possibility that cell therapy treatment with RCS-01 might ameliorate the clinical and aesthetic signs of skin aging, such as wrinkles. This assumption is in line with observations that increased expression of collagen type 1 and type 3 is a prerequisite for wrinkle reduction caused by retinol.
More about the senior authors
Professor Dr. med Jean Krutmann, the paper’s senior author, is Professor of Dermatology and Environmental Medicine and Director of the IUF Leibniz Research Institute for Environmental Medicine at the Heinrich-Heine-University Düsseldorf where the study was conducted. He is a coordinator of the Leibniz Research Alliance “Healthy Aging” (a strategic alliance of 23 Leibniz institutes). His research is in the field of derma-toxicology and immune-dermatology with special emphasis on environmentally-induced skin diseases and skin aging. Prof. Krutmann is author or co-author of more than 400 papers. He is the recipient of the International Arnold-Rikli-Award, the Albert Fleckenstein Award, the Paul Gerson Unna Award, the Oscar Gans Award, the C.E.R.I.E.S. Research Support Award, the Dermopharmacy Innovation Award, and the Xu Guang Qi Lecturer Award.
He is a visiting and adjunct professor at the Nagoya City University, Japan, Case Western Reserve University, Cleveland, Ohio, University of Alabama, Birmingham, AL, USA, and Fudan University, Shanghai, China. He is a member of the National Academy of Science of Germany. He is a clinical consultant to RepliCel Life Sciences and is contributing to the RepliCel-YOFOTO collaboration in China as it relates to the clinical development and commercialization of RepliCel’s RCS-01 skin rejuvenation product.
About Aging and UV-damaged Skin Treatment Markets
Ultra-violet (UV) light exposure from the sun is responsible for up to 80% of visible facial skin aging. According to statistics from the American Society for Plastic Surgeons, $2.5 billion was spent on facial aesthetics in 2013 and this is predicted to grow to over $5.4 billion by 2020. Dermal filler procedures are growing over 15% annually.
About the RCS-01 Study
The clinical trial was a randomized, double-blind, placebo-controlled, single-centre, phase I safety study of intradermal injections of RCS-01 in healthy subjects. The primary endpoint was to assess the local safety profile by recording and evaluating adverse events reported at the treatment evaluation sites. Secondary safety measures related to any reporting of systemic adverse events and assessment of histopathological abnormalities of the treatment sites. Secondary endpoints also included evaluating any changes in expression of selected gene markers (using real-time, quantitative PCR) related to intrinsic skin aging, skin wrinkling and solar degeneration of skin. After trial inclusion, all participants provided a biopsy from the scalp from which RCS-01 was prepared at a central GMP manufacturing site. Study participants were randomized to either a RCS-01 or placebo subgroup. Each participant had four treatment evaluation sites identified on their buttocks, two on each side, to allow for a within-subject comparison of single and triple injections of RCS-01 with placebo respectively. Participants in the RCS-01 Subgroup received injections of RCS-01 or placebo or a ‘sham’ injection (a needle penetration without injection of liquid). Participants in the Placebo Subgroup received only injections of placebo or sham injections to compare the systemic safety profile to the RCS Subgroup. Baseline evaluations of subjects’ overall health and skin condition at treatment sites on their buttocks were performed before receipt of injections at Day 0. In addition to injections delivered at Day 0, the pre-selected treatment evaluation sites received intradermal injections of RCS-01, or placebo, or a sham injection four and eight weeks after Day 0 according to a randomization schedule, for a total of three injections per treatment site. All participants returned to the clinic at regular intervals to monitor safety. Assessment of the local safety profile was performed by the investigator before each injection visit, two to four days after injection, and up to 44 weeks after the last injection. The investigator-assessed local tolerance according to a comprehensive list of pre-specified adverse events. Other study assessments included recording of vital signs at each visit and routine laboratory assessments at regular intervals. At the 12-week time point, nine randomly selected participants provided biopsies from all injection sites for gene expression analysis of skin markers related to aging. At Week-26 the remaining participants provided biopsies of all injection sites for histopathological analysis. All reported pre-defined local adverse events related to injection or sham were transient and mainly mild in intensity only. No other related local or systemic adverse events were reported. No clinically relevant abnormal laboratory results or abnormal vital signs were reported. Histopathological assessments of treatment evaluation site biopsies were all judged to be normal by a blinded investigator.
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. 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 currently being co-developed with, and under exclusive license by, Shiseido 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://www.replicel.com for additional information.
For more information, please contact:
Lee Buckler, CEO and President
604-248-8693
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.
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
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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", "Weighting": 0, "DisableForSiteSearch": false, "CreatedByMemberId": "0", "ItemCategories": [ "News - As Seen In" ], "ItemCategoryIdList": [ 2395 ], "ItemTags": [ "Media", "Skin" ], "Author": 0, "Author_Name": "", "Author_Url": "", "Item_Rating": 0, "Image": "/Blog/2017/ny-dailynews-logo.jpg", "ShowPageForSearchEngine": true, "MetaTitle": "", "SEOTitle": "", "MetaDescription": "", "CanonicalLink": "", "SocialMetaTags": "", "SeoPriority": 0.0, "EnableAMP": false, "AMPContent": "", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ExternalId": 992275, "Params": { "type": "module", "source": "Blog Post", "layout": "List", "displaypagination": "true", "filterby": "itemtags", "limit": "20", "filtervalue": "Skin", "sortby": "releasedate", "sortorder": "DESC", "collectionvariable": "posts" } }, { "Id": 1964, "Name": "Prominent Skin Aging Researcher Provides Insights into RepliCel’s Clinical Data", "Url": "/news/prominent-skin-aging-researcher-provides-insights-into-replicel-s-clinical-data", "Url_List": [ "/news/prominent-skin-aging-researcher-provides-insights-into-replicel-s-clinical-data" ], "UrlSlug": "prominent-skin-aging-researcher-provides-insights-into-replicel-s-clinical-data", "ParentId": 1929, "ParentId_List": [ 1929 ], "ParentName": "News", "ParentUrl": "/news", "TemplateName": "News Template", "Module_Alias": "BlogPost", "Module_ID": 1534, "Enabled": true, "ReleaseDate": "2017-08-09T17:00:00", "ExpiryDate": "2099-12-11T17:00:00", "SiteSearchKeywords": [], "Description": "“We believe that this novel therapy has the potential to rejuvenate skin in a way we’ve never seen before”, states key opinion leader in dermatology research
Dusseldorf, Germany – August 10, 2017 – Following an interview with Prof. Dr. med Jean Krutmann, one of the world’s leading researchers on skin aging, RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA: P6P2) (“RepliCel” or the “Company”) is pleased to provide the following insights regarding the data from RepliCel’s recent clinical study of RCS-01 for aging and sun-damaged skin.
Q: In your center, a phase 1 trial has been performed to assess the safety of an autologous cell product against skin aging. Can you tell us why, in your opinion, the data from this trial suggests to you that such a cell treatment has the potential to treat signs of skin aging?
Prof. Dr. med Jean Krutmann: I am personally very interested in this approach because it represents, to the best of my knowledge, the first cell-based treatment option for skin aging. I had the privilege to oversee the conduct of the phase 1 trial of this product in our Institute. In addition to the results indicating that the therapy is safe to use in humans, we observed in the data from this study that several molecular biomarkers of skin aging significantly improved in areas treated with the cell therapy, as compared to placebo-treated skin.
Q: What do you see as the advantage of cell treatment, compared to other modalities?
Prof. Dr. med Jean Krutmann: The novelty of this cell treatment is that it directly affects and interacts with the dermis and is capable of modulating gene expression in the treated skin. For us this means we expect it will likely show long-term effects on the aesthetic effects of skin aging – in other words, positively impact the skin wrinkles and appearance.
Q: In addition to safety parameters, expression of several molecular markers was assessed as well. What was the purpose of this?
Prof. Dr. med Jean Krutmann: The molecular markers assessed in this study were all related to skin aging. The data suggests the cell therapy can affect the marker expression in a way which indicates that skin aging can be counteracted by being treated with this product. In other words, we believe the data indicates the effects of skin aging can potentially be reversed.
Q: Could you give us your expert opinion about the results?
Prof. Dr. med Jean Krutmann: As a scientist specializing in skin aging and having studied a wide variety of different types of products, I am struck by the efficacy of the treatment. Although the number of study participants was limited, we obtained significant results as compared with placebo-treated skin. For example, we looked for Collagen-1 transcripts in cell-treated versus placebo-treated skin and found a remarkable, statistically significant up-regulation (increase) of collagens in the cell-treated skin. This is very remarkable to see in such a small trial and suggests to me that this product might be very effective in countering the effects of skin aging.
Q: What would be in your view the next steps?
Prof. Dr. med Jean Krutmann: The next natural step is a phase 2 study to directly look at the efficacy of the cell therapy for the treatment of pre-existing clinical signs of skin aging. One of the things being considered is accompanying the clinical study with a research study to provide further insights into the underlying anti-aging mechanisms. Already plans are being finalized for both projects. We believe that this novel therapy has the potential to rejuvenate skin in a way we’ve never seen before.
About Aging and UV-damaged Skin Markets
Ultra-violet (UV) light exposure from the sun is responsible for up to 80% of visible facial skin aging. According to statistics from the American Society for Plastic Surgeons, $2.5 billion was spent on facial aesthetics in 2013 and this is predicted to grow to over $5.4 billion by 2020. Dermal filler procedures are growing over 15% annually.
About the RCS-01 Study
The clinical trial cited by Prof. Dr. med Jean Krutmann is a randomized, double-blind, placebo-controlled, single-centre, phase I study evaluating RCS-01 for the treatment of aging and sun-damaged skin. Recently, statistically and clinically significant positive data was released from the interim analysis of this phase I study. The data revealed a nearly two-fold increase in gene expression of collagen-related biomarkers in the skin, after a single injection of RCS-01. The study observed the impact of the injection on ten different biomarkers that, in peer-reviewed medical literature, are highly correlated with skin aging and chronically sun-damaged skin. Notably, gene expression markers, such as tissue inhibitor of metalloproteinases (TIMP), showed significant changes expected to correlate with increased collagen fibers. Increased collagen production, and reduced collagen degradation, is associated with fewer wrinkles and the repair of sun-damaged skin. Further details are available at http://replicel.com/20170404/.
About Prof. Dr. med Jean Krutmann
Prof Dr. med Jean Krutmann is Professor of Dermatology and Environmental Medicine and Director of the IUF Leibniz Research Institute for Environmental Medicine at the Heinrich-Heine-University Düsseldorf. He is a coordinator of the Leibniz Research Alliance “Healthy Aging” (a strategic alliance of 23 Leibniz institutes). His research is in the field of derma-toxicology and immune-dermatology with special emphasis on environmentally-induced skin diseases and skin aging. Prof. Krutmann is author or co-author of more than 400 papers. He is the recipient of the International Arnold-Rikli-Award, the Albert Fleckenstein Award, the Paul Gerson Unna Award, the Oscar Gans Award, the C.E.R.I.E.S. Research Support Award, the Dermopharmacy Innovation Award and the Xu Guang Qi Lecturer Award. He is a visiting and adjunct professor at the Nagoya City University, Japan, Case Western Reserve University, Cleveland, Ohio, University of Alabama, Birmingham, AL, USA, and Fudan University, Shanghai, China. He is a member of the National Academy of Science of Germany. He is a clinical consultant to RepliCel Life Sciences, Inc.
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 for 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 is also developing 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 / info@replicel.com
Forward-looking information
Certain statements in this news release are forward-looking statements, which reflect the expectations of management regarding the potential effects of RCS-01 on skin aging. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Forward looking statements in this news release include: statements relating to the anti-aging potential of RCS-01, its ability to show long term aesthetic effects on skin aging; its ability to counteract skin aging and revise the effects of skin aging; the Company’s expectation that significant changes to gene expression markers are expected to correlate with increased collagen fibers; that increased collagen production and reduced collagen degradation should potentially lead to fewer wrinkles and the repair of sun-damaged skin; that the RCS-01 therapy is a novel therapy that has the potential to rejuvenate skin in a way never seen before; the potential correlation between changes in biomarkers and clinically important endpoints; that the Company will conduct a phase 2 study; the potential application for other aesthetic products; and the expected timing of return of trial participants for analysis and the process to be undertaken in connection with same. 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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VANCOUVER, BC – April 4, 2017 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”) is pleased to report statistically and clinically significant positive data from the interim analysis of its phase I study evaluating RCS-01 for the treatment of aging and sun-damaged skin.
The primary objective of this trial was to establish a complete safety profile for intradermal injections of RCS-01 (RepliCel’s type 1 collagen-expressing, hair follicle-derived fibroblasts [“NBDS cells”]) at six months post-injection. Participants in the Germany-based study did not report any serious adverse events at the interim point of the trial. Researchers also gathered compelling positive proof-of-concept data indicating the product’s potential for skin rejuvenation.
The study was neither powered for, nor was expected to show statistically significant results of efficacy. However, the nearly two-fold increase in gene expression of collagen-related biomarkers in the skin, after a single injection of RCS-01, was so profound with a single RCS-01 injection, that the results are considered statistically significant. The study observed the impact of the injection on ten different biomarkers that, in peer-reviewed medical literature, are highly correlated with skin aging and chronically sun-damaged skin. Notably, gene expression markers, such as tissue inhibitor of metalloproteinases (TIMP), showed significant changes expected to correlate with increased collagen fibers. Increased collagen production, and reduced collagen degradation, is associated with fewer wrinkles and the repair of sun-damaged skin.
“This type of positive effect on TIMP gene expression, which is related to protection against collagen degeneration, is rarely observed. In my experience, after decades of performing these tests, this is an exceptional finding, particularly for a safety trial with a small sample size,” stated Prof. Dr. med Jean Krutmann, Scientific Manager of the IUF Leibniz Research Institute for Environmental Medicine where the study was conducted. “The promising results demonstrate the potential of RCS-01 to promote skin rejuvenation. An increase in collagen markers of this nature would be expected to translate into clinically measurable and aesthetically visible effects.”
Krutmann concluded: “Replication of these results in a larger trial would confirm our view of the product’s potential as a more natural alternative to Botulinum toxins and fillers that only temporarily prevent and reverse the signs of aging.”
“This study not only showed an excellent safety profile, but also provides compelling proof-of-concept that RepliCel’s RCS-01 cells are, by nature, very good collagen producers in the skin,” stated Dr. Rolf Hoffmann, RepliCel’s Chief Medical Officer. “We are highly encouraged by the findings and eager to demonstrate the correlation between the change in these biomarkers and clinically important endpoints such as wrinkle depth, in a larger multi-centre trial studying optimal dose and treatment frequency.”
“As a practicing dermatologist,” Hoffmann continued, “the potential of RCS-01 represents a leap-forward in the way we look at skin anti-aging, especially for the fine wrinkles in UV-damaged skin where we have no long-lasting treatment today. Of importance is the fact that, because RCS-01 is comprised of cells derived from tissue at the back of the patient’s scalp, these cells are not only very good collagen producers, but also UV- protected and therefore more functionally active.”
“In my opinion,” Hoffmann concluded, “this is the first example of a treatment potentially capable of rejuvenating UV-damaged skin.”
“This is the most compelling data we have announced to date,” stated RepliCel CEO and President, R. Lee Buckler. “Longer term, this data is very complementary to our focus on commercializing a next-generation dermal injector and its targeted application not only with RCS-01, but also with other aesthetic products on the market today. We look forward to discussing these findings and the potential of our products with a number of aesthetic-focused institutional investors and major multinational licensing partners who have already expressed interest in our programs.”
About Aging and UV-damaged Skin Markets
Ultra-violet (UV) light exposure from the sun is responsible for up to 80% of visible facial skin aging. According to statistics from the American Society for Plastic Surgeons, $2.5 billion was spent on facial aesthetics in 2013 and this is predicted to grow to over $5.4 billion by 2020. Dermal filler procedures are growing over 15% annually.
About the RCS-01 Study
The clinical trial was a randomized, double-blind, placebo-controlled, single-centre, phase I safety study of intradermal injections of RCS-01 in healthy subjects. The primary endpoint was to assess the local safety profile by recording and evaluating adverse events reported at the treatment evaluation sites. Secondary safety measures related to any reporting of systemic adverse events and assessment of histopathological abnormalities of the treatment sites. Secondary endpoints also included evaluating any changes in expression of numerous genetic markers (using real-time PCR) related to intrinsic skin aging, skin wrinkling and solar degeneration of skin.
After trial inclusion, all participants provided a biopsy from the scalp from which RCS-01 was prepared at a central GMP manufacturing site. Study participants were randomized to one of two treatment subgroups that received intradermal injections of either RCS-01 or placebo. Each participant had four treatment evaluations sites identified on their buttocks, two on each side to allow for a within-subject comparison of single and triple injections of RCS-01 with placebo respectively. Participants in the RCS-01 Subgroup received injections of RCS-01 or placebo or a ‘sham’ injection (a needle penetration without injection of liquid). Participants in the Placebo Subgroup were randomized to receive only injections of placebo or sham injections to compare the systemic safety profile to the RCS Subgroup.
Baseline evaluations of subjects’ overall health and skin condition at treatment sites on their buttocks were performed before receipt of injections at Day 0. In addition to injections delivered at Day 0, the pre-selected treatment evaluation sites received intradermal injections of RCS-01 or placebo (cryomedium) or a sham injection four and eight weeks after Day 0 according to a randomization schedule for a total of three injections per treatment site.
All participants returned/will return to the clinic for at least nine visits to monitor safety. Assessment of the local safety profile was performed by the investigator before each injection visit, two to four days after injection, and 12 and 26 weeks after injection. The investigator was asked to examine each treatment site for the presence or absence of local adverse events and grade them with respect to relatedness to treatment, severity and seriousness. Other study assessments included recording of vital signs at each visit and routine laboratory assessments at screening, injection visits and at the Week 26 time point. At the 12-week time point, nine randomly selected participants provided biopsies from all injection sites for gene expression analysis of skin markers related to aging. At Week-26 (cut-off date of the interim analysis), the remaining participants provided biopsies of all injection sites for histopathological analysis.
All reported pre-defined local adverse events related to injection or sham were transient and mainly mild in intensity only. No other related local or systemic adverse events were reported. No clinically relevant abnormal laboratory results or abnormal vital signs were reported up to the cut-off date of this interim analysis. Histopathological assessments of treatment evaluation site biopsies were all judged to be normal by a blinded investigator.
About Prof. Dr. med Jean Krutmann
Prof Dr. med Jean Krutmann is Professor of Dermatology and Environmental Medicine and Director of the IUF Leibniz Research Institute for Environmental Medicine at the Heinrich-Heine-University Düsseldorf. He is a coordinator of the Leibniz Research Alliance “Healthy Aging” (a strategic alliance of 23 Leibniz institutes). His research is in the field of derma-toxicology and immune-dermatology with special emphasis on environmentally-induced skin diseases and skin aging. Prof. Krutmann is author or co-author of more than 200 papers. He is the recipient of the International Arnold-Rikli-Award, the Albert Fleckenstein Award, the Paul Gerson Unna Award, the Oscar Gans Award, the C.E.R.I.E.S. Research Support Award and the Dermopharmacy Innovation Award. He is a visiting and adjunct professor of dermatology at the Nagoya City University, Japan, Case Western Case Western Reserve University, Cleveland, Ohio and University of Alabama, Birmingham, AL, USA. He is a member of the National Academy of Science of Germany and Xu Guang Qi Lecturer, Shanghai Institute for Biological Sciences (CAS), Shanghai, China.
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 for 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 is also developing 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
Certain statements in this news release are forward-looking statements, which reflect the expectations of management regarding the results of the RCS-01 Phase 1 skin trial. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Forward looking statements in this news release include: statements relating to the anti-aging potential of RCS-01, its ability to promote skin rejuvenation, and its potential as a more natural alternative to Botulinum toxins and fillers; the Company’s expectation that significant changes to gene expression markers are expected to correlate with increased collagen fibers; that increased collagen production and reduced collagen degradation should potentially lead to fewer wrinkles and the repair of sun-damaged skin; that RepliCel’s RCS-01 cells are by nature very good collagen producers in the skin; the potential correlation between changes in biomarkers and clinically important endpoints; that the potential of RCS-01 represents a leap-forward in skin anti-aging; the potential application for other aesthetic products; and the expected timing of return of trial participants for analysis and the process to be undertaken in connection with same. 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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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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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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