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Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its full-year 2012 financial results and ongoing progress with IPI-145, its potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, and retaspimycin HCl, its potent and selective inhibitor of heat shock protein 90 (Hsp90), and anticipates reporting clinical data from both these programs this year. Infinity also announced today that it initiated five new expansion cohorts in its trial of IPI-145 in patients with advanced hematologic malignancies.
“We made important progress on our product development goals last year, reporting encouraging preliminary data from our Phase 1 trial of IPI-145 in patients with advanced hematologic malignancies, initiating a Phase 2a trial of IPI-145 in patients with asthma, and completing enrollment in our Phase 2, double-blind, randomized, placebo-controlled trial of retaspimycin HCl in non-small cell lung cancer,” stated Adelene Q. Perkins, Infinity’s president and chief executive officer. “We entered 2013 in a strong financial position with approximately $327 million in cash and investments and anticipate this will be a year of fundamental progress for Infinity, as data generated from our ongoing trials will inform our potential registration paths as we continue building a sustainable, fully-integrated biopharmaceutical company.”
In December 2012, Infinity reported encouraging preliminary data at the Annual Meeting of the American Society for Hematology (ASH) showing clinical activity at each of the doses of IPI-145 evaluated from 8 mg through 75 mg twice daily (BID), indicating a potential broad therapeutic window. Infinity has now defined 75 mg BID as the maximum tolerated dose and has leveraged the adaptive approach of its Phase 1 trial to continue to explore the safety, pharmacokinetics and activity of IPI-145 at 75 mg BID in five additional expansion cohorts of patients with the following hematologic malignancies:
1. Chronic lymphocytic leukemia, indolent non-Hodgkin lymphoma and mantle cell lymphoma2. T-cell lymphomas3. Aggressive B-cell lymphomas4. Myeloid neoplasms5. T-cell or B-cell acute lymphoblastic leukemia/lymphoma