updated 2/22/2011 8:17:35 AM ET 2011-02-22T13:17:35

CAMBRIDGE, Mass., Feb. 22, 2011 (GLOBE NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) today announced the initiation of the randomized Phase 2 portion of the trial of IPI-926 in combination with gemcitabine (also known as Gemzar®) in patients with previously untreated, metastatic, pancreatic cancer. The Phase 2 portion of the trial is a double-blind study that will compare treatment with IPI-926 in combination with gemcitabine to treatment with placebo and gemcitabine. The primary endpoint is overall survival. The trial is expected to enroll approximately 120 patients worldwide. Pancreatic cancer, a difficult-to-treat disease with limited therapeutic options, is the fourth leading cause of cancer death in the U.S. and has a five-year survival rate of only six percent.

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, including pancreatic cancer. Inhibiting Smoothened with IPI-926 is believed to deplete the dense, fibrous stroma surrounding pancreatic tumors, leading to increased vascularity and facilitating the delivery of chemotherapy to the tumor.

"IPI-926 may represent a novel method for treating pancreatic cancer by altering the tumor microenvironment and improving the delivery of chemotherapy to the tumor," said Charles Fuchs, M.D., MPH, Director, Gastrointestinal Cancer Center at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. "Pancreatic cancer is a very aggressive disease with limited treatment options. The start of this Phase 2 trial marks an important step in exploring the potential of IPI-926 in this area of cancer research."

"Unfortunately, survival has not improved substantially for patients with pancreatic cancer in over 40 years due in large part to the lack of effective treatment options for patients," stated Julie Fleshman, President and CEO of the Pancreatic Cancer Action Network. "The Pancreatic Cancer Action Network encourages all patients to consider clinical trials when exploring treatment options. Clinical trials evaluating potential new treatments for pancreatic cancer, like this study with IPI-926, will hopefully lead to advances with the potential to improve survival for patients."

Trial Design

The Phase 1b/2 clinical trial evaluates the safety and efficacy of IPI-926 in combination with gemcitabine in patients with previously untreated, metastatic pancreatic cancer. The Phase 2 portion of the trial is an international, multi-center, randomized, double-blind, study designed to compare treatment with IPI-926 in combination with gemcitabine to treatment with placebo and gemcitabine in approximately 120 patients. The primary endpoint of the Phase 2 portion of the trial is overall survival. Secondary endpoints include progression free survival, time to progression and overall response rate.

The Phase 1b portion of the study evaluated once-daily oral administration of IPI-926 at escalating doses in combination with weekly intravenous administration of the standard dose of gemcitabine and established 160 mg as the dose of IPI-926 that will be used in the Phase 2 portion of the ongoing trial. Infinity expects to present data from the Phase 1b portion of the trial later this year.

"In less than two years, we have translated a breakthrough preclinical finding of IPI-926 in pancreatic cancer into a randomized, controlled clinical trial, underscoring our commitment to patients fighting this devastating disease," stated Julian Adams, Ph.D., president of research and development at Infinity. "Beyond pancreatic cancer, preclinical data suggest that inhibition of the Hedgehog pathway has application across a broad range of difficult-to-treat cancers, and we are planning to begin additional studies with IPI-926 in 2011."

About Pancreatic Cancer

Pancreatic cancer is the fourth leading cause of cancer death in the U.S., and it is estimated that more than 43,000 people are diagnosed with pancreatic cancer in the U.S. annually. Notoriously difficult to treat, pancreatic cancer has the lowest survival of all major cancers. The one-year relative survival rate for pancreatic cancer is 25 percent and the five-year relative survival rate is just six percent. The average life expectancy for patients with metastatic disease is three to six months. Unfortunately, pancreatic cancer is one of the few cancers for which the survival rate has not improved substantially over nearly 40 years. (Sources: American Cancer Society, pancan.org).

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 Gemzar® (gemcitabine) in previously untreated patients with metastatic pancreatic cancer. 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 Hedgehog pathway inhibition and IPI-926 in addressing cancer, the reporting of clinical data in 2011, the expectation that Infinity will begin additional studies with IPI-926 in 2011 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. 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 November 9, 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.

Gemzar® is a registered trademark of Eli Lilly and Company.

CONTACT:  Jaren Irene Madden
          617-453-1336
          Jaren.Madden@infi.com

© Copyright 2012, GlobeNewswire, Inc. All Rights Reserved

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