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Chipscreen Biosciences Announces Achievement of Primary Endpoint in Chidamide Registrational Trial in China
Date:4/16/2013

SHENZHEN, China, April 16, 2013 /PRNewswire/ -- Chipscreen Biosciences, a leading integrated Chinese biotech company specialized in discovery and development of novel small molecule pharmaceuticals with a primary focus in oncology, metabolic disease, and autoimmune diseases, today announced the achievement of the primary endpoint in the pivotal, registrational Phase 2 CHIPEL trial of Chidamide (Epidaza®), an orally active benzamide type of class I-selective histone deacetylase (HDAC) inhibitor. The NDA filing has been granted as an accelerated review by the China Food and Drug Administration (CFDA).

The CHIPEL trial was an open-labeled, single arm study in Chinese population to evaluate efficacy and safety of orally administrated Chidamide with relapsed or refractory peripheral T-cell lymphoma (PTCL) patients, who had failed at least one prior systemic therapy. The CHIPEL trial surpassed an objective response rate (ORR) of at least 27%, the primary endpoint as a prior established agreement with CDE of CFDA, evaluated by both investigators and independent review committee. The trial results will be presented on June 3, 2013 at the Lymphoma and Plasma Cell Disorders Poster Discussion Session in the 2013 ASCO Annual Meeting, to be held in Chicago, USA.

"We are pleased to confirm that the trial has achieved its primary endpoint although the pathological subtypes of PTCL in Chinese population are significantly different from that in North America and Europe, where two FDA approved PTCL drugs, Pralatrexate and Romidepsin, were tested," stated Xian-Ping LU, Ph.D., Chief Executive Officer and Chief Scientific Officer of Chipscreen Biosciences Ltd. "We also expect efficacy and safety findings of Chidamide in combination with chemotherapeutic regimen for NSCLC in an ongoing Phase II trial."

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SOURCE Shenzhen Chipscreen Biosciences, Ltd.
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