|Arena Reports Closing of Phase 1b Clinical Trial for APD811; Astex Shares On Watch Following Positive Top-Line Data for SGI-0110|
|By Staff and Wire Reports|
|Thursday, 29 August 2013 18:21|
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced the completion of a Phase 1b clinical trial for APD811, an investigational oral prostacyclin (IP) receptor agonist intended for the treatment of pulmonary arterial hypertension (PAH). The company plans to initiate a Phase 2 clinical trial for APD811 in the first quarter of 2014.
"Arena's internal GPCR-focused efforts led to the discovery of this novel drug candidate," said William R. Shanahan, M.D., Arena's Senior Vice President and Chief Medical Officer. "We believe APD811 is a promising new chemical entity that could improve current patient care by providing an oral option for IP-targeted therapy. Based on the encouraging Phase 1 results, we look forward to initiating the Phase 2 program early next year."
This randomized, double-blind and placebo-controlled Phase 1b clinical trial evaluated the safety, tolerability and pharmacokinetics of multiple-ascending doses of APD811. Arena previously evaluated single-ascending doses of APD811 in a Phase 1a clinical trial.
In the Phase 1b clinical trial, 40 healthy volunteers received APD811 and 15 received placebo, and the safety profile of APD811 was characteristic of IP receptor agonists. No serious adverse events were observed, and the most frequent treatment-emergent adverse events were headache, nausea and jaw pain. The results of the Phase 1 program led to the decision to proceed with Phase 2 development of APD811, which will include further exploration of dosing regimens in PAH patients.
Astex Pharmaceuticals, Inc. (Nasdaq: ASTX) announced top-line results from the ongoing phase 2 of SGI-110 in patients with AML and MDS. The Phase 2 study is a randomized study of SGI-110 given either as 60 or 90 mg/m2 daily for 5 days in a 28-day course. As of end of June data cutoff, 67 AML patients had a minimum follow up of 3 months (50 patients representing the complete cohort of relapsed/refractory AML, and 17 patients in the treatment-naive elderly AML not suitable for induction chemotherapy cohort).
The primary endpoint is overall remission rate (Complete Remission or CR; Complete Remission with Incomplete hematologic recovery or CRi/CRp). There were 8 remissions in relapsed/refractory AML and 9 remissions in treatment-naive elderly AML for an overall complete remission rate (CR, CRi/CRp) of 17/67 or 25%. The detailed results have been submitted for presentation to the American Society of Hematology (ASH) meeting to be held later this year during December 7-10 in New Orleans, LA.
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