updated 10/14/2010 8:45:46 AM ET 2010-10-14T12:45:46

CAMBRIDGE, Mass., Oct. 14, 2010 (GLOBE NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) announced that results from its Phase 2 study of IPI-504, a novel IV-administered Hsp90 chaperone inhibitor, in patients with advanced non-small cell lung cancer (NSCLC) were published in the Journal of Clinical Oncology (Sequist et. al., J Clin Oncol. doi: 10.1200/JCO.2010.30.8338, 2010). These data, presented previously at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO), documented for the first time the activity of an Hsp90 inhibitor in a molecularly defined cohort of patients with advanced NSCLC. In the study, IPI-504 was generally well tolerated and demonstrated clinical activity, particularly among patients with oncogenic anaplastic lymphoma kinase (ALK) gene rearrangements.

"These results support molecular analysis as a key tool in clinical trials to determine the signature of the best responding patients, and suggest that patients with NSCLC and ALK rearrangements may preferentially respond to Hsp90 chaperone inhibition," stated Lecia Sequist, M.D., MPH, from the Massachusetts General Hospital Cancer Center and an Assistant Professor of Medicine at Harvard Medical School. "We hope the ongoing study of IPI-504 in NSCLC patients with ALK rearrangements will validate these initial findings."

"We are encouraged that IPI-504 was generally well tolerated and demonstrated clinical activity in NSCLC, further supporting the clinical potential of Hsp90 chaperone inhibition as a targeted approach to treating certain cancers," stated Julian Adams, Ph.D., president of research and development, Infinity. "The results of the ongoing Phase 1b study of IPI-504 in combination with Taxotere® in patients with solid tumors, as well as data from Dr. Sequist's study assessing IPI-504 in patients with NSCLC and ALK rearrangements, will help inform the path forward for IPI-504."

Trial Design and Results

The Phase 2 study of IPI-504 was designed to evaluate the safety, tolerability and anti-tumor activity of IPI-504 in patients with stage IIIb/IV NSCLC whose tumors had progressed after treatment with an EGFR tyrosine kinase inhibitor. Seventy-six patients were enrolled and stratified by their EGFR mutation status. A subset of patients also underwent EGFR (n = 25), KRAS (n = 30) and BRAF (n = 5) genotyping analysis, as well as a fluorescent in situ hybridization (FISH) assay to detect ALK gene rearrangements.

The results of the Phase 2 study show an objective response rate of seven percent in the overall study population: ten percent in patients who were EGFR wild-type, four percent in those with EGFR mutations, and 12 percent among KRAS wild-type patients. There was a 67 percent response rate among the patients with ALK rearrangements, with two of three patients experiencing partial responses and the third patient experiencing a 24 percent disease reduction. All three patients with ALK rearrangements received IPI-504 for at least six months.

IPI-504 was generally well-tolerated in this study. Most adverse events were Grade 1 or Grade 2. The most commonly reported adverse events (regardless of relationship to drug) were fatigue, nausea, diarrhea, vomiting and cough.

About Infinity's Hsp90 Program

Infinity is developing two proprietary Hsp90 chaperone inhibitor product candidates, IPI-504 (IV) and IPI-493 (oral) in multiple indications. IPI-504 is currently being evaluated in a Phase 1b trial in combination with Taxotere® (docetaxel) in patients with advanced solid tumors and in an investigator sponsored trial in NSCLC patients with ALK rearrangements. Infinity is also conducting two Phase 1 trials with IPI-493, one in patients with advanced solid tumors and one in patients with hematological malignancies.

Hsp90 plays a role in regulating the stability of key proteins involved in oncogenesis, proliferation and survival through its role as a protein chaperone. Proteins chaperoned by Hsp90, known as client proteins, include oncogenic forms of ALK, BCR-ABL, EGFR, FLT3, HER2 and JAK2. 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, Hsp90 chaperone inhibition may represent an important approach to treating certain cancers.

About Infinity Pharmaceuticals, Inc.

Infinity is an innovative drug discovery and development company seeking to discover, develop, and deliver to patients best-in-class medicines for difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Infinity's programs in the inhibition of the Hsp90 chaperone system, the Hedgehog pathway, fatty acid amide hydrolase and phosphoinositide-3-kinase are evidence of its innovative approach to drug discovery and development. For more information on Infinity, please refer to the company's website at http://www.infi.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding the therapeutic potential of Hsp90 chaperone inhibition and the analysis of data from both the Phase 1b study in combination with Taxotere and the investigator-sponsored trial to inform future clinical development of Infinity's Hsp90 inhibitors. Such statements are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations. For example, there can be no guarantee that Infinity's strategic alliance with Purdue Pharmaceutical Products L.P. and Mundipharma International Corporation Ltd. will continue for its expected term or that they will fund Infinity's programs as agreed, that IPI-504 or IPI-493 will successfully complete necessary phases of clinical development, or that development of any of Infinity's product candidates will continue. Further, there can be no guarantee that any positive developments in Infinity's product portfolio will result in stock price appreciation. In particular, management's expectations could be affected by risks and uncertainties relating to: results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Infinity's ability to enroll patients in its clinical trials; unplanned cash requirements and expenditures; and Infinity's ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" included in Infinity's quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 4, 2010. Further, any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Taxotere® is a registered trademark of sanofi-aventis.

© Copyright 2012, GlobeNewswire, Inc. All Rights Reserved

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