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Chipscreen Biosciences and HUYA Bioscience Int'l Announce Promising Preclincial and Phase I Solid Tumor/Lymphoma Data for Chidamide/HBI-8000, New HDAC Inhibitor for Cancer
Date:10/23/2008

HUYA has previously received positive pre-IND comments from the FDA Oncology Division for HBI-8000, including its willingness to accept both preclinical and clinical data generated in China as supportive information for the opening of a US IND and initiation of a Phase I trial. Both a Phase II/III lymphoma trial in China and a Phase I solid tumor/lymphoma trial in the US are planned for early 2009.

Preclinical Profile and Clinical Results

Chidamide/HBI-8000 is an orally bioavailable, low nanomolar inhibitor of cancer-associated HDACs and is one of the most potent inhibitors in the benzamide class. It selectively inhibits tumor cell growth, relative to normal cells, with a therapeutic index of over 20-fold.

Patients received escalating oral doses of 5 to 50 mg Chidamide/HBI-8000 either two or three times per week for four weeks, followed by a two week drug-free period for up to six cycles. PK parameters indicated significant exposure and this was validated by biomarker activity levels comparable to, but lasting longer than, most HDAC inhibitors. Chidamide/HBI-8000 produced significant activity in this early stage trial, with five out of twenty-five evaluable subjects experiencing a partial response and eleven with stable disease. The only dose-limiting toxicities (DLTs) were gastrointestinal in nature. Additional DLTs seen with other HDAC inhibitors, such as bone marrow suppression, fatigue and QTc prolongation were not observed with Chidamide/HBI-8000, supporting a best in class safety profile.

Results will be presented by Michael J. Newman, PhD, Executive Vice President, Oncology, HUYA Bioscience International at the Cambridge Healthtech Institute's annual conference on HDAC inhibitors, Thursday, October 23.

About HDACs and HDAC inhibitors

HDAC inhibitors, a new class of cancer drugs, work by controlling how tightly DNA is wound around accessory proteins, histones. By deacetylating (removing an acetyl group from) histones,
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SOURCE HUYA Bioscience International; Chipscreen Biosciences
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