DUBLIN, Calif., June 20, 2013 (GLOBE NEWSWIRE) -- Astex Pharmaceuticals, Inc. (Nasdaq:ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, today announced that updated clinical data from the dose escalation part of a randomized phase 1/2 clinical trial of subcutaneous SGI-110, a novel hypomethylating agent, in patients with relapsed/refractory acute myelogenous leukemia (r/r AML) will be presented in an oral session during the European Cancer Congress 2013 (ECCO-ESMO-ESTRO) in Amsterdam, Netherlands September 27 - October 1, 2013.
Abstract #3.601, "Study of the correlation of baseline biomarkers and DNA demethylation to clinical responses in a phase 1/2, randomized study of SGI-110, a novel subcutaneous (SC) hypomethylating agent (HMA), in the treatment of relapsed/refractory (r/r) acute myeloid leukemia (AML)," has been selected for oral presentation in the "Hematological Malignancies" proffered paper session on September 28th at 11:15 am CEST.
The presentation will include details of r/r AML responses in the dose escalation part of the trial, and the correlation between these responses and several baseline and DNA methylation biomarkers.
About SGI-110:
SGI-110 is a novel small molecule, DNA-hypomethylating agent administered as a single small volume subcutaneous injection. SGI-110 demonstrated activity in restoring silenced tumor suppressor gene expression in cancer cells by reversal of DNA methylation and inducing responses in previously treated MDS and AML patients. SGI-110 is wholly owned by Astex Pharmaceuticals.
About the SGI-110 study in MDS and AML patients (Study SGI-110-01):
The SGI-110-01 trial is a randomized phase 1/2 study in patients with MDS and AML. The trial completed its phase 1 dose escalation segment (Part A) and the results were presented at the December 2012 ASH meeting, "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." A copy of this presentation is available on the Astex Pharmaceuticals website, www.astx.com, in the pipeline, presentations and publications section.
This study is currently in the phase 2 dose expansion segment (Part B) of the study. Its primary objective is to estimate overall response rates in four patient cohorts (relapsed/refractory AML; relapsed-refractory MDS; front-line elderly AML not suitable for induction chemotherapy; and front-line MDS). Secondary objectives include estimating the incidence and severity of adverse events, duration of response, overall survival, and the correlation of demethylation, genetic, and pharmacologic biomarkers with response. Additional information about the study can be found online at clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01261312.
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.
For more information about Astex Pharmaceuticals, Inc., please visit http://www.astx.com.
Forward-Looking Statements
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.