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FDA Approves Zhong Ensheng's Clinical Phase 2 Trial of Allogeneic Stem Cells In U.S.

TAIPEI, Taiwan, July 7, 2018 (translated from Chinese) -- Steminent Biotherapeutics announced that a new stem cell test for neurodegenerative cerebellar atrophy has been approved by the U.S. FDA and will begin a Phase 2 clinical trial.

CEO Zhang Zhigang said that Zhong Ensheng Medical is targeting cerebellar atrophy, having obtained an orphan drug designation for that condition in 2015.

The FDA approved a Phase 2 clinical trial using an allogeneic mesenchymal stem cell-based drug, the first in Taiwan and in Asia to obtain the second Phase of U.S. clinical approval.

Zhong Ensheng Medical, a regenerative medicine company that promotes allogeneic mesenchymal stem cells, was established in 2009 to develop new drugs from adipose mesenchymal stem cells.

In 2016, the Japanese listed company ReproCELL was authorized to jointly develop the Japanese market for a cerebellar atrophy treatment.

The clinical trial application has been formally submitted to Japan's PMDA to obtain a temporary drug license under the Japanese Recycling Medicine Law after the completion of the pending trial.

He Huijun, executive director of Zhong Ensheng Medical, said the U.S. FDA approved the company's second-Phase clinical implementation of a new drug using allogeneic mesenchymal stem cells.

The neurodegenerative disease cerebellar atrophy does not have any effective treatment.

Zhong Ensheng has a world-class stem cell research and development team and technology, and has strong domestic and foreign scholars and physicians to support the company's scientific, clinical and regulatory development.

The core technology platform Stemchymal, using autologous and allogeneic adipose mesenchymal stem cells, is backed by leading stem cell separation, purification, and proliferation technology. With the most rigorous pharmaceutical specifications and quality management.,

Zhong Ensheng's stem cell products have been tested through clinical trials at top medical centers at home and abroad.

In addition to the Phase 2 clinical trial in cerebellar atrophy, Zhong Ensheng has performed a number of clinical trials of stem cell drugs, including in acute liver failure.

This year, the Phase 1 clinical trial in degenerative knee arthritis has been completed.

The second Phase of human clinical trials in Taiwan for the treatment of cerebellar atrophy with allogeneic mesenchymal stem cells is now being implemented, with completion expected within two years.

FDA Approves IND For Phase 2 Clinical Trial Spinocerebellar Ataxia (July 2018)

In related news, Steminent Biotherapeutics Inc. announced last July that the FDA had raised no objections to the company's Investigational New Drug (IND) application for a Phase 2 clinical trial in polyglutamine spinocerebellar ataxia (PolyQ SCA) conducted at clinical sites in the U.S.

This is a key milestone for the company's international Stemchymal SCA Phase 2 clinical trials program.

"Our Phase 2 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," said Jennifer Ho, managing director of Steminent USA. 'The first of these Phase 2 trials is enrolling patients in Taipei and now, with FDA consent, we are very pleased to initiate this U..S 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 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 Susan Perlman, clinical director, UCLA Ataxia Center. "It is estimated that about 15,000 people in the U.S. suffer from PolyQ SCA disease."

The company manufactures Stemchymal SCA in Taipei; and shipping studies for the U.S. trial have been completed. With this FDA approval, the company will now focus on preparing the U.S. trial sites and starting patient enrollment.

Stemchymal is the platform technology producing standardized allogeneic stem cells isolated from human adipose tissues in accordance with regulatory guidelines and stringent quality control criteria for pharmaceutical grade therapeutics.

Stemchymal SCA is an orphan designated drug (ODD) candidate for polyQ SCA.

Steminent Biotherapeutics Inc. is a stem cell clinical development company in Taipei, Taiwan, with subsidiaries in San Diego and Shanghai

It is dedicated to the development of novel cellular therapeutics for the treatment of diseases with unmet or under-served medical needs.

Steminent uses advanced technologies to isolate, purify, amplify, and manufacture standardized stem cell products of the highest quality for research and clinical development in multiple indications.

Steminent's Stemchymal allogeneic cell therapy R&D program has generated a portfolio of clinical stage therapeutic candidates for multiple diseases including: spinocerebellar ataxia (PolyQ SCA), osteoarthritis of the knee, and acute liver failure.

Contact: Steminent U.S., Inc., 4370 La Jolla Village Drive, Northern Trust Building, Suite 400, San Diego, CA 92122
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Title Annotation:In The Clinic...
Publication:Stem Cell Research News
Geographic Code:9JAPA
Date:Mar 25, 2019
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