RCS-01
RepliCel Launches Preparations for Second Skin Rejuvenation and Tendon Regeneration Clinical Studies
4 years ago
May 19, 2021
Clinical research organization, Accerise Inc., has been retained to work with RepliCel and its other...
Clinical Data Published from RepliCel’s Skin Rejuvenation Study
5 years ago
Sep 24, 2019
Clinical Data Published from RepliCel’s Skin Rejuvenation StudyA paper entitled, “Autologous Cell Therapy for Aged Human...
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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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"Description": "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.
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