Infinity (INFI) Offers New Data from Phase 1b Trial of Saridegib
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Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced updated data from the Phase 1b portion of an ongoing Phase 1b/2 clinical trial of saridegib (also known as IPI-926) in combination with the chemotherapy gemcitabine in patients with previously untreated, metastatic pancreatic cancer. These findings were presented during a poster session at the American Society of Clinical Oncology’s 2012 Gastrointestinal Cancers Symposium (ASCO-GI) in San Francisco (Abstract #213) and support the ongoing Phase 2, double-blind, randomized, placebo-controlled trial comparing saridegib in combination with gemcitabine to placebo and gemcitabine. In October 2011, Infinity announced the completion of enrollment in the Phase 2 portion of the trial, and the company expects to report topline Phase 2 data in the second half of 2012. The primary endpoint of the Phase 2 portion of the trial is overall survival.
Data from the Phase 1b, open-label study in 16 patients showed that saridegib in combination with gemcitabine was well-tolerated and clinically active. As previously reported, the recommended Phase 2 dose of saridegib in combination with gemcitabine was established at 160 mg administered orally once daily, which is the maximum tolerated dose of saridegib when administered as a single agent. The adverse events observed were consistent with the known safety profile of each agent. In addition, partial responses were observed in five of 16, or 31 percent, of patients treated at three different dose levels of saridegib. New data reported today showed that median progression-free survival was 7.6 months (95 percent confidence interval (CI): 3.5 - 8.7 months) and median overall survival was 10.2 months (95 percent CI: 5.7 - 12.3 months).
On January 31, 2012, Infinity will discuss its research and development of saridegib, including the company’s science and supporting rationale for the clinical development of saridegib along with the anticipated milestones for this program in the second half of 2012. A brief summary of the Phase 1b data of saridegib presented at ASCO-GI will also be included. The event will be held from 10:00 a.m. to 12:00 p.m. EST at the Hotel Sofitel New York City.
Data from the Phase 1b, open-label study in 16 patients showed that saridegib in combination with gemcitabine was well-tolerated and clinically active. As previously reported, the recommended Phase 2 dose of saridegib in combination with gemcitabine was established at 160 mg administered orally once daily, which is the maximum tolerated dose of saridegib when administered as a single agent. The adverse events observed were consistent with the known safety profile of each agent. In addition, partial responses were observed in five of 16, or 31 percent, of patients treated at three different dose levels of saridegib. New data reported today showed that median progression-free survival was 7.6 months (95 percent confidence interval (CI): 3.5 - 8.7 months) and median overall survival was 10.2 months (95 percent CI: 5.7 - 12.3 months).
On January 31, 2012, Infinity will discuss its research and development of saridegib, including the company’s science and supporting rationale for the clinical development of saridegib along with the anticipated milestones for this program in the second half of 2012. A brief summary of the Phase 1b data of saridegib presented at ASCO-GI will also be included. The event will be held from 10:00 a.m. to 12:00 p.m. EST at the Hotel Sofitel New York City.
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