updated 4/3/2011 1:46:51 PM ET 2011-04-03T17:46:51

CAMBRIDGE, Mass., April 3, 2011 (GLOBE NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) today announced encouraging results for its novel Smoothened antagonist, IPI-926, in a preclinical model of chondrosarcoma, a life-threatening cancer of the cartilage. The data demonstrated that IPI-926 inhibited tumor growth and led to tumor calcification in primary patient-derived chondrosarcoma tumor xenografts. These data, generated through a collaboration with Drs. Jay Wunder and Ben Alman at University of Toronto, were presented during a major symposium session at the American Association for Cancer Research (AACR) 102nd Annual Meeting 2011 in Orlando, Florida.

IPI-926 is a novel, oral molecule that inhibits Smoothened, a key component of the Hedgehog pathway. Inhibition of the Hedgehog pathway represents a fundamentally new approach for addressing a broad range of cancers. In February 2011, Infinity initiated a randomized, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of IPI-926 compared to placebo in patients with metastatic or locally advanced, inoperable chondrosarcoma. The trial is expected to enroll over 100 patients worldwide. There are no approved systemic treatments for this disease. When surgery is no longer possible, chondrosarcoma is uniformly fatal.

"In this preclinical model of chondrosarcoma, we showed for the first time that the Hedgehog pathway signals directly to tumor cells that do not have a mutation in the pathway, supporting the clinical development of IPI-926 in chondrosarcoma," stated Julian Adams, Ph.D., president of research and development at Infinity. "The rapid translation of our preclinical findings into a rigorous Phase 2 trial demonstrates our commitment to develop medicines that make a meaningful difference to patients."

The activity of IPI-926 was assessed in human primary chondrosarcoma tumors obtained at surgery from multiple donors and grown as subcutaneous xenografts in mice, a model that closely resembles human disease. In the study, oral daily administration of IPI-926 significantly suppressed tumor growth compared to control in multiple xenografts. Administration of IPI-926 also inhibited Gli-1 mRNA expression, a marker of Hedgehog pathway activation, in chondrosarcoma tumor cells. In addition, mice treated with IPI-926 showed changes in tumor morphology, including calcification and loss of cellularity. The presentation may be found in the Publications Archive on Infinity's website, http://www.infi.com/product-candidates-publications.asp .

A late-breaking poster highlighting this work, "Direct targeting of the Hedgehog pathway in primary chondrosarcoma xenografts with the Smoothened inhibitor IPI-926," will also be presented on Tuesday, April 5, 2011, from 1:00 p.m. – 5:00 p.m. ET in Exhibit Hall A4-C, Poster Section 39. This presentation may also be found on Infinity's website on Tuesday, April 5, after 1:00 p.m. ET.

About Chondrosarcoma

Chondrosarcoma is a rare, life-threatening cancer of the cartilage. In the U.S., chondrosarcoma accounts for approximately one-third of the 2,000 cases of primary bone cancer diagnosed each year.i The most common locations for chondrosarcoma tumors are the bones of the extremities and the pelvis.i Chondrosarcoma predominantly affects middle-aged and older adults, usually occurring in patients over 40 years old, with the incidence gradually increasing up to age 75.ii,iii Symptoms associated with chondrosarcoma depend upon the size and location of the tumor and often include pain that increases in severity over time, localized swelling and decreased range of motion in joints near the affected bone.iii,iv The standard therapeutic strategy for chondrosarcoma is surgery. These tumors are largely resistant to chemotherapy and radiotherapy. For patients with metastatic disease or with locally advanced tumors who are not candidates for surgery, no treatment has been shown to be effective and there is no established standard of care.

About the Hedgehog Pathway and IPI-926

Malignant activation of the Hedgehog pathway occurs in a broad range of cancers through three distinct mechanisms: signaling to the tumor microenvironment, signaling to tumor progenitor cells, and signaling directly to tumor cells. IPI-926 is a small molecule that inhibits Smoothened (Smo), a key component of the Hedgehog pathway. Smo inhibition represents a significant anti-cancer opportunity for addressing a number of difficult-to-treat cancers by disrupting malignant activation of the pathway.

IPI-926 is currently being evaluated in the Phase 2 portion of an ongoing trial in combination with gemcitabine in previously untreated patients with metastatic pancreatic cancer and in a Phase 2 study as a single agent in patients with chondrosarcoma. In a Phase 1 trial of IPI-926 in advanced solid tumors, including a cohort of patients with basal cell carcinoma, IPI-926 has been generally well-tolerated and demonstrated evidence of clinical activity. 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, 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 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 potential utility of Smoothened inhibition and IPI-926 in addressing chondrosarcoma and other cancers, the rationale for development of IPI-926 in chondrosarcoma, and clinical trial enrollment expectations. 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-926 will successfully complete necessary preclinical and clinical development phases or that Infinity's strategic alliance with Mundipharma International Corporation Ltd. (Mundipharma) will continue for its expected term or that Mundipharma 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; Infinity's ability to enroll patients in its clinical trials; unplanned cash requirements and expenditures, including in connection with business development activities; the 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 annual report on Form 10-K filed with the Securities and Exchange Commission on March 16, 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.

Sources:

i National Comprehensive Cancer Network Practice Guidelines in Oncology – V.3.2010. Bone Cancer.

ii Dorfman HD, Czerniak B, Kotz R,, Vanel D, Park YK, Unni KK. WHO classification of tumours of bone: Introduction. In: Fletcher CDM. Unni KK, Mertens F.eds. World Health Organization Classification of Tumours. Pathology and Genetics of Tumours of Soft Tissue and Bone. Lyon, France: IARC Press; 2002.

iii Yasko Aw, Chow W, Fressica D. Bone Sarcomas. In: Pazdur R, Wagman LD, Camphausen, Hoskins WJ, eds. Cancer Management: A Multidisciplinary Approach (ed 12): CMPMedicas LLC; 2008.

iv Springfield D, Rosen G. Bone Tumors. In: Kufe DW, Bast RC, Hait WN, Hong WK, Pollock RE, Weichselbaum RR, Holland JF, Frei E, eds. Cancer Medicine 7 (ed 5). Hamilton, Ontario: BC Decker; 2006; 1686-1687. 

CONTACT: Infinity Pharmaceuticals, Inc.
         Jaren Irene Madden, 617-453-1336
         Jaren.Madden@infi.com
         http://www.infi.com

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