Semafore's SF1126, a Vascular Targeted Pan-PI3K/mTOR Inhibitor, Is Well Tolerated and Demonstrates Activity in Phase I Solid Tumo...( Clinical Data Presented at the 2009 A...),Health

Clinical Data Presented at the 2009 ASCO Meeting

INDIANAPOLIS, May 30 /PRNewswire/ -- Semafore Pharmaceuticals, Inc., a privately held cancer drug discovery and development company, today presented data from a Phase I clinical trial of its vascular targeted pan-PI3K/mTORC1/2 inhibitor, SF1126, at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Orlando, Florida.

Dr. E. Gabriela Chiorean, from the Indiana University Simon Cancer Center in Indianapolis, IN presented the interim Phase I data on SF1126 in 36 advanced solid tumor patients. The majority of patients were heavily pretreated with a median of four prior chemotherapy regimens. Sixteen of 36 (44%) patients achieved disease stabilization with a median duration of 12 weeks. Of note, a GIST, endometrial, and prostate cancer patient each achieved durable stable disease for 20 weeks (5 mos.). These specific tumor types are associated with aberrations of the PI3K pathway that commonly lead to resistance and poor prognostic outcomes.

Pharmacodynamic analysis of tumor tissue confirmed inhibition of the PI3K pathway by complete absence of a downstream target (pS6). In contrast, a normal tissue (skin) demonstrated no inhibition providing evidence of tumor selectivity of SF1126. Pharmacokinetics displayed dose proportionality and no accumulation between cycles.

SF1126 was well tolerated. The most common side effects were grade 1 or 2 vomiting (42%), nausea (39%), diarrhea (33%), fever (22%), fatigue (19%), chills (14%), and puritis (11%). There were two patients with grade 3 toxicity, one with diarrhea, the other with urticaria and pruritis. Notably, there were no clinically significant changes in glucose or insulin levels reported.

"Based on these Phase I results we are encouraged that SF1126 is well tolerated and may hold promise for the treatment of solid tumor maligna
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