News | June 29, 2010

Infinity Initiates Second Clinical Trial Of IPI-493, Its Oral Hsp90 Chaperone Inhibitor

Cambridge, MA (GLOBE NEWSWIRE) - Infinity Pharmaceuticals, Inc. (Nasdaq:INFI), an innovative drug discovery and development company, today announced that patients are being enrolled in a Phase 1 clinical trial evaluating IPI-493 in patients with advanced hematologic malignancies. This multi-center study is the second clinical trial of IPI-493, Infinity's oral heat shock protein 90 (Hsp90) chaperone inhibitor.

"We are pleased to expand our clinical investigation of IPI-493, as we think its oral availability may provide flexibility in dose and schedule and the potential to be combined with other cancer drugs in earlier lines of therapy," said Julian Adams, Ph.D., president of research and development, Infinity. "Importantly, this study in hematologic malignancies enables us to closely measure potential client protein degradation by IPI-493, which should give us an early read on the therapeutic opportunity with our oral agent."

The primary objectives of this study are to assess safety and tolerability of IPI-493 in patients with advanced hematologic malignancies, and to identify an optimal dose and schedule for subsequent studies. Pharmacokinetic parameters and effects of IPI-493 on pharmacodynamic markers of biological activity will also be assessed. In preclinical models, IPI-493 has demonstrated good oral availability, as well as potent and selective inhibition of the Hsp90 chaperone system.

Information regarding the trial, including participating clinical trial sites, is available at www.clinicaltrials.gov.

IPI-493 is also being evaluated in a Phase 1 clinical trial in patients with advanced solid tumors. Infinity anticipates reporting data from its Phase 1 program with IPI-493 in 2011.

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, and fatty acid amide hydrolase 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 those regarding the utility of Hsp90 chaperone inhibition, the therapeutic potential of IPI-493, and the presentation of clinical data for IPI-493. 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 IPI-493 will successfully complete necessary preclinical and clinical development phases. Management's expectations could also 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, including in connection with business development activities; the continuation of Infinity's strategic alliance with Purdue Pharmaceutical Products L.P. and Mundipharma International Corporation Ltd.; 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 May 6, 2010. 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.

SOURCE: Infinity Pharmaceuticals, Inc.

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