1 August 2018
San Diego, CA, USA, August 1st, 2018 – Steminent Biotherapeutics Inc. (“Steminent” or “Company”) a private, clinical-stage cell-therapy company with offices in Taiwan, San Diego and Shanghai, is pleased to announce that the Clinical Trial Notification (“CTN”), submitted by their Japan partner; ReproCELL, to the Japan Pharmaceuticals and Medical Device Agency (“PMDA”) for a Stemchymal® SCA Phase II clinical trial for Polyglutamine Spinocerebellar Ataxia (“PolyQ SCA”) has been approved. This is another key milestone for Steminent’s international Stemchymal® SCA Phase II clinical development program with trials now moving ahead in Taiwan, US, and Japan.
Steminent’s Phase II Stemchymal® SCA clinical program includes trials to evaluate safety and efficacy from treating PolyQ SCA patients in three countries. “The first of these Phase II trials is currently enrolling patients in Taiwan, the FDA has approved the IND for a PII trial in the US, and now we are very pleased that ReproCELL can initiate a Phase II trial to assess Stemchymal® SCA in treating PolyQ SCA patients in Japan”, said Ryan Chang, CEO of Steminent.
In Japan, the “Pharmaceutical and Medical Device Act” and the “Act on the Safety of Regenerative Medicine” came into effect in 2014. Under this new system, the “Time-limited Conditional Approval”, which allows one to conditionally sell regenerative medicine products while continuing following clinical trials, could be obtained by showing safety and potential efficacy of the product in clinical trials. This new system is expected to accelerate the development of regenerative medicine products in Japan.
“Taiwan is also to implement a conditional market approval pathway for cell therapy products upon achieving sufficient evidence of safety and efficacy in PII clinical trials,” commented by Ryan Chang. “So with strong Phase II trial results, Stemchymal® SCA could also achieve earlier approval to help address the unmet need for treatment in PolyQ SCA patients in Taiwan.”
With this PMDA approval, ReproCELL can now move forward on preparing the Japan trial sites and starting patient enrollment in Japan.
Stemchymal® is the platform technology producing standardized allogeneic stem cells product isolated from human adipose tissues in accordance with regulatory guidelines and stringent quality control criteria for pharmaceutical grade therapeutics. Stemchymal® SCA is an FDA orphan designated drug (ODD) candidate for polyQ SCA.
SCAs are life-threatening, rare neurodegenerative diseases that cause progressive difficulty with coordination. In general, the prevalence of SCA is between 2~7/100,000. There are more than 30 subtypes of SCA. PolyQ SCAs including SCA1, SCA2, SCA3, SCA6, SCA7 and SCA17 are caused by an extensive CAG sequence repeat which encodes for expanded polyglutamine residues within the mutated protein. The age of onset associated with PolyQ SCA disease patients can range from twenty years old to fifty years of age.
Steminent Biotherapeutics Inc. is the leading stem cell clinical development company in Taipei, with subsidiaries in San Diego and Shanghai, dedicated to the development of novel cellular therapeutics for the treatment of diseases with unmet or under-served medical needs. Steminent utilizes advanced, proprietary processes and know how to isolate, purify, amplify and manufacture standardized stem cell products of the highest quality for research and clinical development in multiple indications. ReproCELL is Steminent’s partner for developing and commercializing Stemchymal® SCA in Japan.
Steminent’s Stemchymal® allogeneic cell therapy R&D program has generated a portfolio of clinical stage therapeutic candidates for multiple diseases including:
Phase II; Spinocerebellar Ataxia (PolyQ SCA), Phase I; Osteoarthritis of the Knee, and Phase I: Acute Liver Failure.
REPROCELL (4978: TSE JASDAQ) was established in 2003 with a goal of contributing to people’s health and welfare through the development of stem cell technologies. REPROCELL successfully went public in 2013 as the first iPS cell company on JASDAQ, the Tokyo Stock Exchange Market, and then started to expand their business both globally and rapidly through several M&As. REPROCELL is pursuing two business areas of Discovery and Medical using proprietary human cell technologies including stem cells, biorepository, bioengineered tissue and drug screening. REPROCELL has developed a proprietary process to manufacture integration-free, virus-free and clinically relevant human iPSC lines using proprietary RNA reprogramming technology. This process is suitable for manufacturing robust, consistent and high quality functional cells at commercial scale for use in both pre-clinical and clinical development activities. For more information, see http://www.REPROCELL.com.
Dr. Kevin Ho
Steminent USA, San Diego, CA