Biotherapeutics Inc. (Steminent ) a private, clinical-stage cell-therapy company with offices in Taiwan, San Diego and Shanghai, is pleased to announce that the United States Food and Drug Administration (“FDA”) has raised no objections to the Company’s Investigational New Drug (“IND”) application. This allows the Company to initiate its Phase II clinical trial for polyglutamine spinocerebellar ataxia (“PolyQ SCA”) to enroll patients at clinical sites in the United States. This is a key milestone for the Company’s international Stemchymal® SCA Phase II clinical trials program.
Dr. Jennifer Ho, Managing Director of Steminent USA, states, “Our Phase II Stemchymal® SCA program includes double blinded, randomized, and placebo-controlled trials to evaluate Stemchymal® SCA for safety and evidence of efficacy for treating PolyQ SCA in three countries. The first of these Phase II trials is currently enrolling patients in Taipei, and now with FDA consent, we are very pleased to initiate this US orphan designated drug trial. ReproCELL, our Japan partner, has also submitted its CTN to the PMDA to assess Stemchymal® SCA in treating PolyQ SCA in Japan.”“As there are currently no approved treatments for this progressive, irreversible disease, we are encouraged by the possibility that Stemchymal® cell therapy may demonstrate safety and therapeutic benefit in these patients.” said Dr. Susan Perlman, Clinical Director, UCLA Ataxia Center, Professor of Neurology, UCLA, and Medical Director; National Ataxia Foundation, “It is estimated that about 15,000 people in the USA suffer from PolyQ SCA disease.”The Company manufactures Stemchymal® SCA in Taipei and shipping studies for the US trial have been completed. With this FDA approval, the Company will now focus on preparing the US trial site(s) and starting patient enrollment.
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.