SHENZHEN, China, Jan. 09, 2015 -- Chipscreen Biosciences today announced regulatory approval of Chidamide (Epidaza®), the world first orally administrated and subtype-selective histone deacetylase (HDAC) inhibitor for relapsed or refractory peripheral T-cell lymphoma (PTCL) patients, in China on Dec. 23, 2014 by the Chinese Food and Drug Administration (CFDA).
Peripheral T-cell lymphomas (PTCL) is a set of rare and heterogeneous group of mature T- and natural killer (NK)-cell neoplasms associated with poor outcome. PTCL makes up 25 percent to 30 percent of all Non-Hodgkin's lymphoma (NHL) cases in China, much higher than that seen in Western countries of 10 percent to 15 percent. The subtype distribution of PTCL is also significantly different between China and Western countries, in which extranodal NK/T-cell lymphoma, nasal type (ENKL), a subtype highly aggressive with very poor prognosis, to be the leading subtype in Chinese population.
"Chidamide is the first new molecular entity discovered and developed by Chipscreen scientists in China. The CFDA's decision to approval the world first orally administrated selective HDACi for PTCLs is an important validation of the drug's therapeutic potential for this urgent medical need for Chinese PTCLs patients. The orally administrated Chidamide not just will provide affordable innovative treatment for the Chinese patients whom otherwise have no option to obtain most up-to-dated new treatment beyond conventional chemotherapies, but also have great potential, based on its unique epigenetic mechanism of actions and existing knowledge from the field, to be easily combined with other treatment modalities in comprehensive control and management of cancer patients in fight against drug resistance and tumor recurrence," said Xian-Ping LU, Ph.D., Chief Executive Officer and Chief Scientific Officer of Chipscreen Biosciences Ltd.
About Chidamide (Epidaza®)
Chidamide is an orally bioavailable, low-nanomolar inhibitor of cancer-associated histone deacetylase (HDAC) enzymes with favorable pharmacology and tolerability profiles relative to existing benzamide and non-benzamide HDAC inhibitors. It targets specifically the subtype 1, 2, 3 of Class I and subtype 10 of Class IIb HDAC and is 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. In clinically administrated concentrations, it demonstrated a unique epigenetic mechanism of actions against tumor cell development, involving preferential induction of growth arrest and apoptosis in blood and lymphoid-derived tumor cells, activation of NK-mediated and CD8-mediated antigen-specific cellular anti-tumor immunity, differentiation of tumor stem cells, reversal of drug-resisting tumor cells and epithelia to mesenchymal transition, which are hallmarks of treatment resistance, tumor cell metastasis and recurrence.
Information about Chidamide: www.epidaza.com
Chipscreen Biosciences is the leading Chinese biotech company specialized in discovery and development of novel small molecule pharmaceuticals with a primary focus in oncology, metabolic disease, and autoimmune diseases. 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 formed in 2001.
For Chipscreen Biosciences