Preclinical Data Show Anti-Tumor Activity With Infinity's Oral Hsp90 Inhibitor IPI-493

Studies Further Demonstrate Potency and Selectivity of Infinity's Leading Hsp90 Inhibitors


GENEVA and CAMBRIDGE, Mass., Oct. 22, 2008 (GLOBE NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) today announced preclinical data demonstrating anti-tumor activity with IPI-493, Infinity's oral heat shock protein 90 (Hsp90) inhibitor. These data were presented today at the EORTC-NCI-AACR (EORTC) Symposium on "Molecular Targets and Cancer Therapeutics" in Geneva, Switzerland.

In preclinical studies, IPI-493 potently inhibits Hsp90 and has strong pharmaceutical properties in vitro and in vivo, including selectivity for cancer cells over normal cells, as well as high oral bioavailability. Moreover, IPI-493 showed significant anti-tumor activity in multiple xenograft models. Notably, Infinity presented evidence of significant dose-dependent inhibition of tumor growth in a xenograft model of human-derived non-small cell lung cancer, with tumor regression seen at higher doses.

"The biologic activity and cancer cell selectivity we have seen with oral IPI-493 is very promising," said Julian Adams, Ph.D., president of research and development and chief scientific officer at Infinity. "By developing an oral inhibitor of Hsp90 to complement our i.v. inhibitor, IPI-504, we have the opportunity to provide physicians and patients with dose and schedule flexibility in multiple cancer settings, both as a single agent and in combination with other therapies."

In another preclinical poster presented at EORTC, Infinity demonstrated the biochemical, cellular,and in vivo properties of its geldanamycin derived inhibitors IPI-504 and IPI-493 compared to a number of fully synthetic Hsp90 inhibitors also in clinical development. When tested against a broad panel of cancer cell lines, IPI-504 and IPI-493 demonstrated a competitive mix of pharmacological properties, including potent cell growth inhibition against a broad range of cancer cells, selectivity for cancer cells over normal cells, and pharmacodynamic activity in vivo.

"These data further underscore Infinity's commitment to industry-leading research and development in Hsp90 inhibition," added Vito Palombella, Ph.D., vice president of drug discovery at Infinity. "The potency and selectivity seen to date with our novel lead candidate IPI-504 and with IPI-493, its oral complement, illustrate the unique advantages of geldanamycin derivatives, and position Infinity at the forefront of this exciting area of cancer research."

Infinity announced earlier this year that it has initiated a Phase 1 clinical trial evaluating IPI-493 in patients with advanced solid tumors. The study is designed to assess the safety and tolerability of IPI-493 and to identify a dose and schedule for subsequent clinical studies. Infinity is also evaluating biologic activity by Response Evaluation Criteria in Solid Tumors (RECIST) and disease specific markers.

About IPI-493 and Heat Shock Protein 90 (Hsp90)

Hsp90 is a central component of the cellular chaperone system -- a system that supports and stabilizes a number of cancer-causing proteins such as c-Kit, EGFR, and HER2, enabling multiple forms of cancer to thrive. Inhibition of the Hsp90 chaperone knocks out this critical source of support for cancer cells, leading to tumor growth inhibition and cancer cell death. Anti-chaperone therapy via inhibition of Hsp90 may represent a significant yet currently unaddressed strategy for treating patients with cancer. Infinity is developing two proprietary anti-chaperone agents in collaboration with AstraZeneca, IPI-504 i.v. (retaspimycin hydrochloride) and IPI-493 oral, which have shown potent and selective inhibition of Hsp90 in preclinical studies.

IPI-493 is a novel, orally bioavailable formulation of 17-AG (17-amino-17-demethoxygeldanamycin), which is of the same chemical class as Infinity's lead product IPI-504. IPI-493 is the first reported successful formulation of 17-AG as a potential oral cancer therapeutic. In vitro and in vivo studies demonstrate the strong pharmaceutical properties of IPI-493, including potent inhibition of Hsp90, selectivity for cancer cells over normal cells, as well as high oral bioavailability. IPI-493 has also shown significant anti-tumor activity in multiple xenograft models, including dose-dependent inhibition of tumor growth. IPI-493 is currently in a Phase 1 study in patients with advanced solid tumors.

About Infinity Pharmaceuticals, Inc.

Infinity is an innovative cancer drug discovery and development company seeking to discover, develop, and deliver to patients best-in-class medicines for the treatment of cancer and related conditions. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging cancer pathways. Infinity's two most advanced programs in Hsp90 inhibition and Hedgehog signaling pathway inhibition are evidence of its innovative approach to oncology 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 potential utility of IPI-504 and IPI-493 to treat cancer and future clinical trial activity for IPI-504 and 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 any product candidate Infinity is developing will successfully complete necessary preclinical and clinical development phases or that any preclinical data will be replicated in clinical studies. 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; Infinity's dependence on its collaboration with AstraZeneca; Infinity's ability to obtain additional funding required to conduct its research, development, and commercialization activities; 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 that 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 for the quarter ended June 30, 2008, as filed with the Securities and Exchange Commission on August 6, 2008. 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.



            

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