More than 40 MDS patients who are treatment-naive to prior hypomethylating agents have already been enrolled out of a target of 50 patients. Other patients being treated in the phase 2 expansion part of the study include: relapsed/refractory MDS; relapsed/refractory AML; and treatment-naive elderly AML patients who are unfit for induction chemotherapy.
This poster will be available for viewing on the company's website, www.astx.com , in the pipeline, presentations and publications section.
Further presentations on all 4 cohorts in the phase 2 part of the study are planned in future scientific meetings with the first presentation being planned for the upcoming American Society of Hematology (ASH) meeting in New Orleans in December.
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-110-01trial 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.