Chipscreen Biosciences Announces Achievement of Primary Endpoint in Chidamide Registrational Trial in China
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.”
Chidamide is a Class I HDAC inhibitor being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic agents for the treatment of various hematological and solid cancers. Its anticancer effects are thought to be mediated through multiple mechanisms of action, including the inhibition of cell proliferation, induction of apoptosis, inhibition of epithelial to mesenchymal transition (EMT, a process that is highly relevant to tumor cell metastasis and drug resistance), induction of tumor specific antigen and antigen-specific T cell cytotoxicity, enhancement of NK cell anti-tumor activity, induction of differentiation, and resensitization of tumor cells that have become resistant to anticancer agents such as platinums, taxanes and topoisomerase II inhibitors.
Chipscreen is a leading integrated biotech company specialized in discovery and development of novel small molecule pharmaceuticals. The company has utilized its proprietary chemical genomics-based discovery platform to successfully develop a portfolio of clinical and preclinical stage programs in a number of therapeutic areas. Chipscreen’s business strategy is to generate differentiated drug candidates across multiple therapeutic areas. Drug candidates are either developed by Chipscreen or co-developed and commercialized in a partnership at the research, preclinical and clinical stages. The company was established as Sino-foreign joint venture in 2001.
For Chipscreen Biosciences
Rebecca Hai, (86)-755-26957317
SOURCE Shenzhen Chipscreen Biosciences, Ltd.