Astex Pharmaceuticals initiated the Phase 2 dose expansion segment of the clinical trial of SGI-110, a novel hypomethylating agent, in patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML). Treatment-naive MDS and elderly AML (≥65 years) will be enrolled in the dose expansion. Enrollment is open and the first patient has received treatment as part of the expanded Phase 2 clinical trial.
“The initiation of SGI-110′s Phase 2 expansion of the clinical trial marks an important milestone for our company as we advance the development of our second-generation hypomethylating agent,” said James S.J. Manuso, PhD, chairman & chief executive officer.
“We are pleased with the advancement of SGI-110 into the Phase 2 segment of the clinical trial. The allowance of treatment-naive MDS and elderly AML patients will be important in evaluating efficacy and safety of SGI-110 in this patient population and to further characterize the clinical differentiation of the drug,” stated Mohammad Azab, MD, chief medical officer.
SGI-110 Phase 2 Clinical Trial Study
The Phase 2 expansion will include 90 patients on the five day subcutaneous dosing schedule to better evaluate both efficacy and safety in MDS and AML patients. The primary objective in the dose expansion segment is estimating overall remission rates. Secondary objectives include estimating the incidence and severity of dose limiting toxicity (DLT), the PK profile of SGI-110 and decitabine, rates of hematologic improvement and duration of remission, time to disease progression, overall survival rate, and incidence of blood and platelet transfusions.
Interim Phase 1 clinical data from subcutaneous SGI-110 was previously reported at the American Association for Cancer Research (AACR) 2012 Annual Meeting in Chicago, IL. The data showed that SGI-110 has a clear pharmacokinetic differentiation from Dacogen® (decitabine) for Injection given as an IV infusion. The drug achieved excellent hypomethylation, and major clinical responses in heavily pre-treated AML patients were observed. A copy of the 2012 AACR oral presentation, “Interim results from a randomized Phase 1-2 first-in-human-(FIH) study of PK/PD guided escalating doses of SGI-110, a novel subcutaneous (SQ) second generation hypomethylating agent (HMA) in relapsed/refractory MDS and AML” is available in the pipeline, presentations, and publications section of the Astex Pharmaceuticals Web site.
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 www.astx.com
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