updated 6/1/2011 6:16:23 AM ET 2011-06-01T10:16:23

—    Company to Host Webcast and Conference Call Today at 8:30 a.m. ET with Dr. Gregory Riely, Principal Investigator for Ongoing Phase 2 Trial of Retaspimycin HCl, a Novel Hsp90 Inhibitor —

—    IPI-926, an Oral Smoothened Antagonist, Granted Orphan Drug Designation in Europe for Treatment of Chondrosarcoma —

CAMBRIDGE, Mass., June 1, 2011 (GLOBE NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) will host a webcast and conference call this morning to highlight key aspects of the company's recent clinical progress and review several abstracts accepted by the American Society of Clinical Oncology (ASCO) for presentation during the 47th Annual Meeting being held from June 3 through June 7 in Chicago, Ill. Data to be presented at the ASCO meeting include results from clinical trials of IPI-926, Infinity's oral molecule which targets the Hedgehog pathway by inhibiting Smoothened, and retaspimycin hydrochloride (HCl) (also known as IPI-504), the company's novel heat shock protein (Hsp90) inhibitor.

"We have made strong progress this year building our diverse pipeline of novel product candidates, each derived from a deep understanding of the molecular mechanisms of disease. Data from our two lead product candidates, IPI-926 and retaspimycin HCl, will be presented at ASCO showing that each is well-tolerated and has clinical activity in devastating diseases for which there are limited treatment options," stated Julian Adams, Ph.D., president of R&D at Infinity. "Beyond the presentation of data at ASCO, we are continuing to focus on advancing and expanding our pipeline. By year-end, we expect to have four drug candidates in the clinic and at least five company-sponsored Phase 2 trials ongoing."

During today's call, Gregory Riely, M.D., Ph.D., assistant attending physician, medical oncology, at Memorial Sloan-Kettering Cancer Center, will review the Phase 1b data of retaspimycin HCl in combination with docetaxel (also known as Taxotere®) in patients with non-small cell lung cancer (NSCLC) and offer his clinical perspective on these data and Infinity's development plans. Dr. Riely served as the principal investigator for the Phase 1b trial and is also the principal investigator for the newly initiated Phase 2 study of retaspimycin HCl in combination with docetaxel.

Also on today's call, Infinity will provide the following updates on the company's pipeline:

  • IPI-926 granted Orphan Drug Designation for chondrosarcoma in Europe: Infinity today announced that the European Commission has granted Orphan Drug Designation for IPI-926 for the treatment of chondrosarcoma. In addition to a 10-year period of marketing exclusivity in the European Union after product approval, Orphan Drug Designation provides companies with protocol assistance and regulatory assistance from the European Medicines Agency during the product development phase, direct access to centralized marketing authorization procedure, as well as reductions in certain fees. In March 2011, Infinity received Orphan Drug Designation from the U.S. Food and Drug Administration for IPI-926 for the treatment of chondrosarcoma. 
     
  • IPI-926 data to be presented at ASCO: Data from two clinical trials of IPI-926 will be presented at the ASCO meeting on June 4, 2011. The presentations will include data from the Phase 1b trial of IPI-926 in combination with gemcitabine (also known as Gemzar®) in patients with metastatic pancreatic cancer. Data from the Phase 1 trial of IPI-926 in patients with advanced and/or metastatic solid tumors, including a cohort of patients with basal cell carcinoma, will also be presented.

In the Phase 1b pancreatic cancer trial, IPI-926 administered orally once daily in combination with gemcitabine was well-tolerated. At the time of abstract submission, three radiographic partial responses had been observed in the nine patients who had baseline scans. Updated results from 16 patients in the Phase 1b trial will be presented at the ASCO meeting.

  • Robust Phase 2 development of IPI-926 ongoing: Infinity is currently enrolling patients in two randomized, double-blind, placebo-controlled Phase 2 trials of IPI-926 – one in combination with gemcitabine in patients with metastatic pancreatic cancer and the other as a single agent in patients with chondrosarcoma. Infinity expects to complete enrollment in the pancreatic cancer trial by the end of 2011. Additional Phase 2 development of IPI-926 is expected to begin this year.
     
  • Retaspimycin HCl data to be presented at ASCO: Data from the Phase 1b trial of retaspimycin HCl in combination with docetaxel will be presented at the ASCO meeting on June 6, 2011. Among 23 patients with NSCLC, there were six partial responses, for an overall response rate of 26 percent. Patients with squamous cell carcinoma and patients with a history of heavy smoking, who historically have had poor prognoses and limited treatment options, responded preferentially to the combination, with overall response rates of 43 percent (N = 3/7) and 33 percent (N = 6/18), respectively. Additional safety and efficacy data will be presented at the ASCO meeting.
     
  • Phase 2 trial for retaspimycin HCl under way: Infinity recently announced the initiation of a Phase 2 trial of retaspimycin HCl in combination with docetaxel in patients with NSCLC. The adaptive, randomized trial will evaluate the anti-tumor activity, tolerability and safety of retaspimycin HCl in combination with the standard dose of docetaxel compared to placebo plus docetaxel in approximately 100 second- or third-line NSCLC patients who are naïve to docetaxel treatment. Following an interim analysis to evaluate the relationship between efficacy and certain patient characteristics, Infinity may expand the trial in patient populations that respond preferentially to treatment with the combination.
     
  • Initiation of the first clinical trial of IPI-145 expected in second half of 2011: Infinity is completing activities to enable Phase 1 development of IPI-145 in the second half of 2011. IPI-145 is an orally available, dual inhibitor of phosphoinositide-3-kinase (PI3K) delta and gamma.
     
  • Transition of IPI-940 to Purdue Pharma nearing completion: Infinity is completing activities to transition IPI-940, its oral fatty acid amide hydrolase (FAAH) inhibitor, to its partner, Purdue Pharma L.P. Infinity expects Purdue to begin Phase 2 development of IPI-940 in pain during the second half of 2011. Purdue Pharma, together with its independent associated company Mundipharma International, is responsible for the worldwide development and commercialization of IPI-940, and Infinity is entitled to receive royalties of up to 20 percent on global product sales.

Conference Call Information

To participate in today's conference call at 8:30 a.m. ET, please dial 1-877-316-5293 (domestic) and 1-631-291-4526 (international) five minutes prior to start time. A live webcast of the conference call can be accessed in the Investors/Media section of Infinity's website at www.infi.com . An archived version of the webcast will be available on Infinity's website for 30 days.

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 trial as a single agent in patients with chondrosarcoma. In Phase 1 trials in advanced solid tumors and pancreatic cancer, 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 carcinoma. Historically, these patient groups have had a poor prognosis and limited treatment options.

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: highlighting clinical progress and reviewing abstracts accepted for ASCO in a webcast and conference call; expectations that Infinity will have four drug candidates in the clinic and at least five company-sponsored Phase 2 trials ongoing by the end of 2011; the presentation of clinical data at ASCO from Infinity's (i) Phase 1b trial of IPI-926 in combination with gemcitabine in patients with metastatic pancreatic cancer, (ii) Phase 1 trial of IPI-926 in patients with basal cell carcinoma, and (iii) Phase 1b trial of retaspimycin HCl in combination with docetaxel in patients with NSCLC; Infinity's Phase 2 trial of retaspimycin HCl in combination with docetaxel in NSCLC patients, including expectations regarding enrollment, criteria for evaluation and potential for expansion; enrollment expectations in Infinity's Phase 2 clinical trial of IPI-926 in patients with pancreatic cancer; plans for additional Phase 2 development of IPI-926 in 2011; the therapeutic potential of (i) Smo inhibition, (ii) IPI-926, and (ii) Hsp90 inhibitors, including retaspimycin HCl, in NSCLC when used as part of combination therapy; plans for Phase 1 development of IPI-145; and plans for Phase 2 development of IPI-940 by Purdue Pharma L.P. 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: 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.

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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