Chipscreen Biosciences Announces that a Pivotal Phase III Clinical Trial of Chidamide in Combination with Exemestane in Patients with Breast Cancer Reached Primary Endpoint

Tuesday, May 29, 2018 Clinical Trials News
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SHENZHEN, China, May 29, 2018 /PRNewswire/ -- Shenzhen Chipscreen Biosciences Co., Ltd. ("Chipscreen

Biosciences") has been informed that the company's lead innovative product Epidaza® (Chidamide), an oral subtype-selective histone deacetylase (HDAC) inhibitor previously approved for recurrent and refractory peripheral T cell lymphoma in
China
, in combination with exemestane reached primary endpoint (progression-free survival) in a pivotal phase III clinical trial. This trial is a randomized, double-blind, placebo controlled study involved postmenopausal patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer (ABC) failed to tamoxifen and/or nonsteroidal aromatase inhibitor.

Epigenetic abnormality is a common biological basis for drug resistance in cancer patients. Chidamide is a selective HDAC inhibitor with unique epigenetic mechanisms against tumor cell growth, immune escape and drug resistance. In an exploratory clinical study, it has been demonstrated the encouraging antitumor activity of chidamide in combination with exemestane in HR-positive ABC patients.

This current clinical study is the first HDAC inhibitor combined with exemestane in a pivotal trial to demonstrate progression-free survival benefit and manageable adverse effect in HR–positive ABC patients progressed after prior endocrine therapy.

About Chidamide (Epidaza®)

Chidamide (CS055/HBI-8000/Tucidinostat) 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/targeted agents for the treatment of various hematological tumors, solid cancers and HIV in the United States, Japan, China and Taiwan. 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. Chidamide was approved on December 23rd of 2014 by China Food and Drug Administration (CFDA) for recurrent and refractory peripheral T cell lymphoma in China.

Information about Chidamide: www.epidaza.com

About Breast Cancer

Breast cancer is the most common female malignancy in the world and China. In 2017, China's cancer registry annual report showed that the incidence of new breast cancer cases in China was 279,000, and was increased by 2% annually. Breast cancer deaths account for 69,500 cases and breast cancer is the leading cause of cancer deaths among women aged below 45 years old. Estrogen receptor positive breast cancer accounts for about 70% of all breast cancers and endocrine therapy is the main treatment for this type of patients. However, the problem of treatment resistance in patients with recurrent or progressive disease after endocrine therapy is an important factor affecting the follow-up treatment selection in this type of patients. Endocrine therapy combined with other target drugs can overcome endocrine resistance and significantly prolong the progression free survival of patients. So far, there are 3 CDK4/6 and 1 m-TOR inhibitors in combination with endocrine therapy have been approved by the US FDA for such type of patients, but not yet in China.

About Chipscreen

Chipscreen Biosciences is 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. 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 and commercialized by Chipscreen in China or co-developed and commercialized in a partnership at the research, preclinical and clinical stages outside China. The company was established as Sino-foreign joint venture in 2001.

For Chipscreen Biosciences

Alice Yin, +86-755-26952070Investor Relationsyinmeiling@chipscreen.com

www.chipscreen.com

Cision View original content:http://www.prnewswire.com/news-releases/chipscreen-biosciences-announces-that-a-pivotal-phase-iii-clinical-trial-of-chidamide-in-combination-with-exemestane-in-patients-with-breast-cancer-reached-primary-endpoint-300655621.html

SOURCE Shenzhen Chipscreen Biosciences, Ltd.



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