updated 5/19/2011 8:16:32 AM ET 2011-05-19T12:16:32

CAMBRIDGE, Mass., May 19, 2011 (GLOBE NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) today announced that clinical data for IPI-926, its novel Smoothened antagonist, and retaspimycin hydrochloride (IPI-504), its novel Hsp90 inhibitor, will be presented at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO). Both investigational agents target underlying mechanisms that are responsible for malignant cell growth and survival in a broad range of difficult-to-treat cancers for which limited treatment options are available for patients. The ASCO meeting is being held from June 3 through June 7 in Chicago, Ill.

Key clinical results to be presented during the meeting include Phase 1b data illustrating the safety and clinical activity of IPI-926 in combination with gemcitabine in patients with metastatic pancreatic cancer. Additionally, Phase 1b data showing the safety and clinical activity of retaspimycin HCl in combination with docetaxel in patients with non-small cell lung cancer will be presented.

In addition, Infinity will host a conference call on Wednesday, June 1, 2011, at 8:30 a.m. ET. During the call, Infinity's management team will review the abstracts accepted for presentation at ASCO and provide an update on the company's pipeline. A live webcast of the conference call can be accessed in the Investors/Media section of Infinity's website at www.infi.com . To participate in the conference call, please dial 1-877-316-5293 (domestic) and 1-631-291-4526 (international) five minutes prior to start time. An archived version of the webcast will be available on Infinity's website for 30 days.

Presentations of Infinity's clinical data at ASCO include the following:

Saturday, June 4, 2011, 8:00 a.m. – 12:00 p.m. CT   
Poster Title: The safety of IPI-926, a novel hedgehog pathway inhibitor, in combination with gemcitabine in patients with metastatic pancreatic cancer. (Abstract #4114, Poster 36H)    
Presenter: Brian Wolpin, M.D., Dana Farber Cancer Institute   
Location: Hall A

Saturday, June 4, 2011, 2:00 p.m. – 5:00 p.m. (poster), 5:00 p.m. – 6:00 p.m. CT (discussion)   
Poster Title: A phase I study of IPI-926, a novel hedgehog pathway inhibitor, in patients with advanced or metastatic solid tumors. (Abstract #3014, Poster 4)   
Presenter: Charles Rudin, M.D., Ph.D., The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins   
Location: S403 (poster) and S406 (discussion)

Monday, June 6, 2011, 1:00 p.m. – 5:00 p.m. CT   
Poster Title: Efficacy and safety of retaspimycin hydrochloride (IPI-504) in combination with trastuzumab in patients with pretreated, locally advanced or metastatic HER2-positive breast cancer. (Abstract#590, Poster 7H)   
Presenter: Shanu Modi, M.D., Memorial Sloan-Kettering Cancer Center   
Location: Hall A

Monday, June 6, 2011, 2:00 p.m. – 5:00 p.m. (poster), 5:00 p.m. – 6:00 p.m. CT (discussion)  
Poster Title: Safety and activity of IPI-504 (retaspimycin hydrochloride) and docetaxel in pretreated patients with metastatic non-small cell lung cancer. (Abstract #7516, Poster 5)  
Presenter: Gregory Riely, M.D., Ph.D., Memorial Sloan-Kettering Cancer Center 
Location: E450a (poster) and Hall D2 (discussion)

About Infinity's Hedgehog Program

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 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 (also known as Gemzar®) 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 across a broad range of cancers.

About Infinity's Hsp90 Program

Cancer cells depend on the Hsp90 chaperone to maintain many proteins critical for cancer growth, proliferation and survival in a functional state. Certain anticancer therapies may enhance the dependency of cancer cells on the Hsp90 chaperone. Therefore, combining an Hsp90 inhibitor such as retaspimycin hydrochloride (HCl) with another proven anticancer agent may enhance cancer cell killing.

Retaspimycin HCl is currently being evaluated in a Phase 2 trial in combination with docetaxel (also known as Taxotere®) in patients with non-small cell lung cancer (NSCLC). In a Phase 1b trial of retaspimycin HCl in combination with docetaxel in patients with NSCLC, the combination regimen was well-tolerated and showed evidence of clinical activity, particularly among patients with a history of heavy smoking or with squamous cell histology.

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 presentation of clinical data at ASCO from the Phase 1b trial of IPI-926 in combination with gemcitabine in patients with metastatic pancreatic cancer and the Phase 1b trial of retaspimycin HCl in combination with docetaxel in patients with non-small cell lung cancer, the expectation that Infinity will host a conference call on June 1 to review the abstracts accepted for presentation at ASCO and provide an update on the company's pipeline, the therapeutic potential of Smo inhibition, and the therapeutic potential of an Hsp90 inhibitor such as retaspimycin HCl in combination with another proven anticancer agent. 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. Further, there can be no guarantee that any positive developments in Infinity's product portfolio will result in stock price appreciation.  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 quarterly report on Form 10-Q for the quarter ended March 31, 2011, that was 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.

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

CONTACT: Infinity Pharmaceuticals, Inc.
         Jaren Irene Madden, 617-453-1336
         Jaren.Madden@infi.com
         http://www.infi.com
         
         Media:
         Liz Falcone, 617-761-6727
         Liz.Falcone@fkhealth.com

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