DUBLIN, Calif., Nov. 20, 2012 (GLOBE NEWSWIRE) -- Astex Pharmaceuticals, Inc. (Nasdaq:ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, announced that results from the dose escalation part of a randomized Phase 1/2 first-in-human clinical trial of subcutaneous SGI-110, a novel hypomethylating agent, in patients with relapsed/refractory intermediate or high-risk myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML) will be presented during the American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia on Monday, December 10, 2012 at 11:45 am ET. The oral presentation will be made by Hagop M. Kantarjian, MD, professor and department chair, department of leukemia, cancer medicine division, The University of Texas MD Anderson Cancer Center, Houston, TX. The accepted abstract is available on the ASH website at: https://ash.confex.com/ash/2012/webprogram/Paper49626.html
The dose escalation part of the study demonstrated that SGI-110 is well tolerated at doses higher than the biologically effective dose (BED); subcutaneous (SQ) administration achieved efficient conversion to decitabine resulting in an improved pharmacokinetic (PK) profile over intravenous (IV) Dacogen formulation; and clinical responses were observed in this heavily pretreated population which seem to correlate with the extent of LINE-1 hypomethylation.
"Following the preliminary presentation at AACR, this is the second oral presentation of clinical data for SGI-110 this year in which the full data set of the phase 1 part of the trial will be discussed. We are pleased with the progress of SGI-110 in the treatment of these difficult to treat hematological malignancies," said Mohammad Azab, MD, chief medical officer of Astex Pharmaceuticals.
Additionally, a preclinical data presentation on SGI-110 titled, "SGI-110, a novel hypomethylating agent, induces the WNT inhibitor Secreted Frizzled Related Protein-2 (SFRP2), and down regulates beta-catenin in acute myeloid leukemia (AML) cells," will occur in a poster session on Saturday, December 8, 2012 from 5:30 – 7:30 pm ET.
About the Study
The SGI-110 study enrolled 78 patients (64 AML, 14 MDS), in the dose escalation part of this randomized Phase 1/2 first-in-human trial with 44 patients receiving drug daily for 5 days (dailyx5 regimen) and 34 patients receiving drug once weekly for 3 consecutive weeks (weeklyx3 regimen). Median age was 69 years, and 82% had ECOG PS of 0-1. Median number of prior regimens was 3 (range 1-9), 59% of patients had prior hypomethylation agent (HMA) treatment (50% of AML patients, and 100% of MDS patients). Clinical responses were observed in this heavily pretreated AML and MDS patients.
The study has progressed to the dose expansion part and is actively accruing patients.
A copy of the 2012 ASH presentation, "Results From the Dose Escalation Phase of a Randomized Phase 1-2 First-in-Human (FIH) Study of SGI-110, a Novel Low Volume Stable Subcutaneous (SQ) Second Generation Hypomethylating Agent (HMA) in Patients with Relapsed/Refractory MDS and AML," will be available following the conclusion of the oral presentation on the Astex Pharmaceuticals website, www.astx.com, in the pipeline, presentations and publications section.
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.