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."
About the Study
The primary objective in Stage A of this Phase 2 trial is to determine the safety and tolerability of combination therapy with SGI-110 and carboplatin and to determine the MTD for Stage B. The primary objective in Stage B will be to assess and compare PFS between combination therapy with SGI-110 and carboplatin and treatment of choice arms. Secondary objectives in Stage A and Stage B include assessment of methylation of tumor suppressor genes before and after treatment, objective response rate, clinical benefit rate, duration of response, CA-125 reduction, and overall survival.
SGI-110 is a small molecule, DNA-hypomethyating agent with demonstrated activity in restoring silenced tumor suppressor gene expression in cancer cells by reversal of DNA methylation. A follow-up to the decitabine (Dacogen) franchise, SGI-110 is also being evaluated in a first-in-human Phase 1-2 clinical trial in patients with intermediate or high-risk myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML), in collaboration with multiple cancer centers, including clinical investigators of the Stand Up to Cancer Epigenetics Dream Team.
SGI-110 is wholly owned by Astex Pharmaceuticals.
About Astex Pharmaceuticals
Astex Pharmaceuticals is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology. The Company is developing a proprietary pipeline of novel therapies and is creating de-risked products for partnership with leading pharmaceutical companies. Astex Pharmaceuticals developed Dacogen® (decitabine) for Injection and receives significant royalties on global sales.
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This press release contains "forward-looking" statements within the meaning of Section 21A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and is subject to the safe harbor created thereby. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. Actual results could differ materially from those projected in the forward-looking statements as a result of a number of risks and uncertainties. These forward-looking statements include, but are not limited to, expectations regarding the advancement of drug candidates in the clinic; the Company's ability to develop the current and future pipeline into commercially viable drugs; the expectations regarding our clinical trials including the timing of clinical proof of concept data from these trials. Important factors that could cause actual results to differ materially from the expectations reflected in the forward-looking statements include, but are not limited to: the outcomes of the on-going clinical trials; risks and uncertainties related to the research and development of SGI-110. References made to the discussion of risk factors are detailed in the Company's filings with the Securities and Exchange Commission including reports on its most recently filed Form 10-K and Form 10-Q. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update or revise the information contained in any such forward-looking statements, whether as a result of new information, future events or otherwise.
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Source:Astex Pharmaceuticals, Inc.