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DUBLIN, Calif., Oct. 2, 2012 (GLOBE NEWSWIRE) -- Astex Pharmaceuticals, Inc. (Nasdaq:ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, announced that it has initiated a Phase 2, open label, randomized, multi-center, controlled clinical trial, evaluating SGI-110 in combination with carboplatin in platinum-resistant recurrent ovarian cancer patients.
Study SGI-110-02 will have two stages: a safety lead-in stage (Stage A) followed by a randomized, controlled, open-label stage (Stage B). In Stage A of the study, patients will receive escalating doses of SGI-110 and carboplatin to define the Maximum Tolerated Dose (MTD) and preliminary biological and clinical activity. Once the MTD is defined, and biological activity confirmed, the study will proceed to Stage B. In Stage B of the study, patients will be randomized to receive SGI-110 plus carboplatin at the MTD identified in Stage A, or one of three treatment of choice, standard of care agents, as determined by the clinical investigator: topotecan, pegylated liposomal doxorubicin, or paclitaxel. The primary endpoint in Stage B will be a comparison of progression free survival (PFS) between SGI-110 plus carboplatin, and treatment of choice study arms. Response rate and overall survival will be among the secondary endpoints.
Stage A will enroll approximately 20 patients, and Stage B will enroll 96 patients.
The study is based on preclinical work showing that SGI-110 reverses platinum resistance, and on a clinical study with Dacogen® and carboplatin showing a 35% response rate and 10.2 months median PFS in heavily pretreated platinum-resistant ovarian cancer patients (Matei et al, Cancer Res 2012; 72:2197–2205).
"There is a great need for agents to reverse platinum-resistance as platinum is still the most active agent in ovarian cancer and other tumor types. This proof of concept study will establish the role of SGI-110 in reversing the epigenetic based resistance in patients receiving platinum based standard of care treatment," said Mohammad Azab, MD, chief medical officer. "We are pleased to commence investigational studies of SGI-110 in ovarian cancer with this first ever randomized clinical trial of a DNA hypomethylating agent in combination with platinum in platinum-resistant patients."