Infinity Expands Clinical Development Program for IPI-926, an Oral Smoothened Antagonist Targeting the Hedgehog Pathway

Phase 2 Trial of IPI-926 to be Initiated in Myelofibrosis Based on Biological Rationale for the Role of Hedgehog Pathway Signaling in Malignancies Characterized by Fibrosis

Cambridge, Massachusetts, UNITED STATES

CAMBRIDGE, Mass., June 22, 2011 (GLOBE NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) today announced that it is expanding its clinical development program for IPI-926, a novel, oral small molecule that inhibits Smoothened, a key component of the Hedgehog pathway. As part of this expansion, Infinity plans to initiate an exploratory Phase 2 clinical trial in patients with myelofibrosis, an incurable malignancy of the bone marrow which is characterized by the replacement of normal bone marrow by fibrotic tissue and the production of blood cells in other organs, such as the spleen and liver.

The single-arm, Phase 2 trial is designed to evaluate the safety and efficacy of IPI-926 administered orally once daily in up to 45 patients with myelofibrosis. The primary endpoint of the trial is hematologic response rate. The trial is expected to begin in the third quarter of 2011.

"The important role of the Hedgehog pathway in pathogenic fibrosis leads us to believe that IPI-926 may have application across a range of malignancies, including pancreatic cancer and myelofibrosis, in which malignant cells create a dense, fibrotic, protective microenvironment via the Hedgehog pathway signaling to the stroma," stated Pedro Santabárbara, M.D., Ph.D., chief medical officer at Infinity. "While other agents in development for the treatment of myelofibrosis reduce spleen size, there is still a significant need for novel treatment options that can directly target the malignant fibrosis underlying this disease."

Infinity scientists and their academic collaborators have led the way in validating the role of Hedgehog pathway signaling in the tumor-stroma interaction in pancreatic cancer. Earlier this month, Infinity presented encouraging Phase 1b results for IPI-926 in combination with gemcitabine in patients with metastatic pancreatic cancer. Data from the study showed that IPI-926 was well tolerated and clinically active. Partial responses were observed in five out of 16 patients, for a 31 percent response rate.

Infinity continues to explore other potential indications for IPI-926 and plans to initiate multiple investigator-sponsored trials this year.

About Myelofibrosis

Myelofibrosis, an incurable malignancy of the bone marrow, is characterized by the replacement of normal bone marrow by fibrotic tissue and the production of blood cells in other organs, such as the spleen and liver. The primary manifestations of myelofibrosis are severe anemia resulting in weakness and fatigue, as well as massive enlargement of the spleen (splenomegaly) and liver (hepatomegaly), which result in abdominal pain and ultimately liver failure. The five-year survival rate for myelofibrosis is approximately 40 percent. There are limited treatment options for patients with myelofibrosis, and there are no approved therapeutic agents that directly target the fibrosis that underlies this disease.

About IPI-926 and the Hedgehog Pathway

Malignant activation of the Hedgehog pathway is responsible for a broad range of cancers. IPI-926 targets the Hedgehog pathway by inhibiting Smoothened (Smo), a key signaling component of the Hedgehog pathway. Smo inhibition represents a significant anticancer opportunity for addressing a number of difficult-to-treat cancers by disrupting malignant activation of the pathway.

IPI-926 is currently being evaluated in multiple trials, including a Phase 2 trial in combination with gemcitabine in previously untreated patients with metastatic pancreatic cancer and a Phase 2 study as a single agent in patients with chondrosarcoma. A Phase 2 trial of IPI-926 as a single agent in patients with myelofibrosis is planned to begin in the third quarter of 2011. IPI-926 was well-tolerated and showed clinical activity in a Phase 1b trial in patients with metastatic pancreatic cancer and in a Phase 1 trial in patients with advanced solid tumors, including a cohort of patients with basal cell carcinoma. These clinical trials build upon a robust set of supporting data that provide a strong rationale for evaluating the potential of IPI-926 for treatment across a broad range of 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 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

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: plans to initiate a Phase 2 clinical trial of IPI-926 in patients with myelofibrosis in the third quarter of 2011, the potential of Hedgehog pathway inhibition, including Smo inhibition, in treating a broad range of cancers; potential therapeutic applications of IPI-926; and plans to initiate multiple investigator-sponsored trials in 2011. 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 any product candidate Infinity is developing will successfully complete necessary preclinical and clinical development phases or that development of any of Infinity's product candidates will continue. Management's expectations could also be affected by risks and uncertainties relating to: Infinity's 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; development of agents by Infinity's competitors for diseases in which Infinity is currently developing its product candidates; 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 for the quarter ended March 31, 2011 filed with the Securities and Exchange Commission on May 10, 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.



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