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Semafore Pharmaceuticals Reports Positive Interim Results from a Phase I Study of SF1126, a Targeted Pan-PI3K Inhibitor, in Patients with Advanced Solid Tumors
Date:6/4/2008

INDIANAPOLIS, June 4 /PRNewswire/ -- Semafore Pharmaceuticals Inc. today reported interim data from a Phase I study of its lead product candidate, SF1126, a targeted pan-PI3 kinase (PI3K) inhibitor, in patients with advanced solid tumors. SF1126 is the first PI3 kinase inhibitor to be evaluated clinically in both solid tumor and multiple myeloma trials.

The data from the solid tumor trial demonstrate that SF1126 is well-tolerated in a twice-weekly I.V. infusion at exposure levels that have been shown to be active in preclinical studies. In the current trial, patients are dosed twice-weekly for four weeks, as part of a 28-day SF1126, treatment cycle. Investigators are assessing the safety, activity and pharmacokinetics of SF1126 as measured by standard response evaluation criteria in solid tumors (RECIST).

To date, 17 patients with a wide range of solid tumors have been enrolled in this multicenter, dose-cohort escalating trial, which is being conducted at T-Gen Clinical Research Services in Scottsdale, Ariz.; the Arizona Cancer Center in Tucson, Ariz.; and the IU Simon Cancer Center in Indianapolis. Stable disease has been observed in three of 12 patients who have completed at least one cycle of treatment, including a prostate, endometrial and ovarian cancer patient. Adverse events noted so far were limited to nausea, vomiting, diarrhea and rash. All adverse events have been non-cumulative and reversible. With these encouraging results, patient enrollment has accelerated, and full enrolment of the trial is anticipated by the end of the third quarter.

"As a leader in the clinical development of PI3 kinase inhibitors, we are pleased to announce this positive safety data and early signals of activity seen with SF1126," said Dennis McKeever, Semafore Pharmaceuticals' CEO. "We believe that SF1126's dual action of antitumor and antiangiogenic activity represents a step forward in delivering new therapies to cancer patients."

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SOURCE Semafore Pharmaceuticals Inc.
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