Infinity Initiates Two Phase 1 Trials of IPI-145, a Potent Inhibitor of PI3K Delta and Gamma

- Company Begins Dual Development Path in Inflammation and Hematologic Malignancies —

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that it has initiated two Phase 1 clinical trials of IPI-145, a potent, orally available inhibitor of phosphoinositide-3-kinase (PI3K) delta and gamma. These two enzymes are implicated in hematologic cancers as well as a broad range of inflammatory conditions, which are the areas of focus within Infinity’s PI3K clinical development program.

PI3K delta and gamma are involved in key immune cell functions, including cell proliferation, survival and cellular trafficking. Due to their critical role in the development and maintenance of certain cancers and inflammatory diseases, inhibiting the function of PI3Ks is an increasingly important focus within the medical research community. IPI-145 is currently the only PI3K delta/gamma inhibitor in clinical development. IPI-145 was licensed from Intellikine, Inc. and is part of Infinity’s strategic alliance with Mundipharma International Corporation Limited.

“There have been compelling clinical data showing that PI3K delta inhibition may provide a therapeutic benefit in patients with hematologic malignancies, in addition to our own preclinical data of IPI-145 showing activity in several models of inflammatory disease,” stated Pedro Santabárbara, M.D., Ph.D., chief medical officer at Infinity. “We believe the potency of IPI-145 against both PI3K delta and gamma may provide an advantage over other PI3K inhibitors currently in development. We look forward to evaluating data from these Phase 1 trials, which will guide our Phase 2 development plans for IPI-145.”

The first Phase 1 trial of IPI-145 is a double-blind, randomized, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple escalating doses of IPI-145 in healthy adult subjects.

The second Phase 1 trial is an open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics and clinical activity of IPI-145 in patients with advanced hematologic malignancies. Following the determination of the maximum tolerated dose in the dose escalation phase, an expansion phase will follow in patients with selected hematologic malignancies.

“The initiation of these Phase 1 trials of IPI-145 marks the achievement of a key development objective for Infinity this year,” stated Adelene Q. Perkins, president and chief executive officer at Infinity. “We have started seven clinical studies in 2011, an accomplishment that we believe underscores the productivity of our R&D organization, highlights our commitment to developing therapies for underserved diseases and increases our potential for long-term growth and success.”

About PI3K and IPI-145

The phosphoinositide 3-kinases (PI3Ks) are a family of enzymes involved in key immune cell functions, including cell proliferation and survival, cell differentiation and cellular trafficking. PI3K delta and gamma, two isoforms of PI3K, play key roles in inflammatory and autoimmune diseases. Additionally, in certain hematologic malignancies, PI3K delta and gamma contribute to the survival and proliferation of cancer cells. Therefore, inhibition of PI3K delta and gamma may have therapeutic potential across a broad range of inflammatory diseases and hematologic malignancies.

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 Hedgehog pathway, the Hsp90 chaperone system, phosphoinositide-3-kinase 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 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 therapeutic potential of inhibition of PI3K delta and gamma and the expectation of an expansion phase in the clinical trial of IPI-145 in patients with advanced hematologic malignancies. 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-145 will successfully complete necessary preclinical and clinical development phases or that Infinity’s strategic alliance with Mundipharma International Corporation Limited will continue for its expected term or that it will fund Infinity’s programs as agreed. 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; 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 9, 2011. 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.



CONTACT:

Infinity Pharmaceuticals, Inc.
Jaren Irene Madden, 617-453-1336
[email protected]
http://www.infi.com
or
Media:
Liz Falcone, 617-761-6727

KEYWORDS:   United States  North America  Massachusetts

INDUSTRY KEYWORDS:   Health  Biotechnology  Clinical Trials  Oncology  Pharmaceutical

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