504 whiffs in P2a prostate cancer trial, shares off 8% after hours:
>>Infinity Provides Update On Phase 2 Signal-Finding Clinical Study of IPI-504 in Advanced Prostate Cancer
Monday July 14, 5:13 pm ET
CAMBRIDGE, Ma., July 14, 2008 (PRIME NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (NasdaqGM:INFI - News) today announced that it has decided to discontinue further enrollment in its Phase 2 single agent, signal-finding study of IPI-504 (retaspimycin hydrochloride) in advanced hormone-refractory prostate cancer. Infinity has not observed evidence of biologic activity in the trial and has, therefore, concluded that the overall risk-benefit ratio does not justify continuing a signal-finding study as a single agent in this indication. Biologic activity was not observed in either the fully enrolled group of patients having previously been treated with a docetaxel-based chemotherapy (n=15) or in the group of patients who had not been previously treated with a docetaxel-based chemotherapy (n=4). Patients currently enrolled in this trial may continue receiving IPI-504 after consultation with their physician.
``With our partners at AstraZeneca, we are pursuing a rigorous and broad clinical research program, including multiple early, disease-specific, signal-finding trials to determine which patients we believe are most likely to benefit from our novel anti-chaperone agent,'' said Julian Adams, Ph.D., president of research and development and chief scientific officer at Infinity. ``We remain committed to the clinical development of IPI-504 in GIST and non-small cell lung cancer, where we have seen early evidence of activity, as well as to future studies in additional tumor types.''
Infinity's ongoing trials with IPI-504 in other disease areas include a Phase 2 study in patients with advanced non-small cell lung cancer (NSCLC) and a Phase 1b trial evaluating IPI-504 in combination with docetaxel. In 2007, Infinity reported preliminary evidence of biological activity from the Phase 1 portion of the Phase 1/2 trial in patients with NSCLC who have received at least 12 weeks of treatment with a tyrosine kinase inhibitor. Infinity anticipates reporting preliminary results from the Phase 2 portion of the NSCLC trial by the end of 2008.
Infinity also plans to commence an international Phase 3 registration study of IPI-504 in patients with refractory gastrointestinal stromal tumors (GIST) in the third quarter of 2008 based on the activity and safety data reported at the 2008 Annual Meeting of the American Society of Clinical Oncology. Infinity will conduct this trial under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration and pursuant to scientific advice from the European Medicines Evaluation Agency.
IPI-504 is being jointly developed by Infinity and AstraZeneca/MedImmune.
About Anti-Chaperone Therapy (Hsp90)
Despite recent therapeutic advances, current approaches to treating cancer remain incomplete. Cellular systems critical to the growth and survival of many tumors remain unaddressed by currently available treatments. Heat shock protein 90 (Hsp90) is a central component to the cellular chaperone system -- a system that supports and stabilizes numerous cancer-causing proteins such as c-Kit, EGFR, and HER2. Inhibition of the Hsp90 chaperone knocks out a critical source of support for cancer cells, leading to tumor growth inhibition and cancer cell death. Thus, targeted anti-chaperone therapy via inhibition of Hsp90 may represent a significant yet currently unaddressed strategy for treating patients with cancer. IPI-504 (retaspimycin hydrochloride) is a novel, targeted anti-chaperone agent that has shown potent and selective inhibition of Hsp90 in preclinical studies.<<
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And looks like pretty dead money for a while. Sigh.
Cheers, Tuck |
