CAMBRIDGE, Mass., Oct. 16, 2008 (GLOBE NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (Nasdaq:INFI), an innovative cancer drug discovery and development company, today announced that it has initiated a Phase 1 clinical trial of its oral Hedgehog signaling pathway inhibitor, IPI-926, in patients with advanced and/or metastatic solid tumors.
IPI-926 is a novel, proprietary inhibitor of the Hedgehog signaling pathway. It is a derivative of the natural product cyclopamine that binds to and inhibits a key regulator of this pathway, the Smoothened receptor. The Hedgehog signaling pathway is normally active in regulating tissue and organ formation during embryonic development. However, abnormal activation of the Hedgehog pathway can lead to cancer and is believed to play a central role in allowing the proliferation and survival of several types of cancers, including pancreatic, prostate, lung, breast, and certain brain cancers.
"The medical and scientific communities are very excited about the therapeutic possibilities of Hedgehog pathway inhibitors in oncology," said Charles M. Rudin, M.D., Ph.D., associate director, clinical research at the Johns Hopkins Cancer Center. "We look forward to studying IPI-926 in a variety of solid tumors to better understand how to develop Infinity's Hedgehog pathway inhibitor effectively."
The Phase 1 trial is an open-label, dose-escalation study evaluating IPI-926 in approximately 30 to 50 patients with advanced and/or metastatic solid tumors. The primary objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics of IPI-926, and to determine a recommended dose and schedule for subsequent studies. Additionally, Infinity will evaluate potential anti-tumor activity of IPI-926, and examine pharmacodynamic markers of its biological activity. In this trial, IPI-926 is being administered daily.
"The initiation of this trial marks an important milestone for Infinity. IPI-926 has shown significant oral bioavailability, a long half-life, and excellent in vivo activity in preclinical models," stated Julian Adams, Ph.D., president of research and development and chief scientific officer at Infinity. "We are enthusiastic about the potential of IPI-926 and look forward to pursuing additional studies across a breadth of tumor types in the future."
IPI-926 Preclinical Data
Infinity presented preclinical data on IPI-926 during the Annual Meeting of the American Association of Cancer Research (AACR) in April 2008, including data showing that in a novel model of medulloblastoma, IPI-926 demonstrated excellent oral bioavailability, a long plasma half-life and duration of action, and good distribution to tumor tissue. In addition, daily oral administration of IPI-926 in this model led to dose-dependent inhibition of tumor growth, with tumor regression seen at higher doses.
Additional data presented at AACR demonstrated that IPI-926 delayed tumor growth following chemotherapy in a preclinical model of small cell lung cancer (SCLC). In this model, following tumor debulking with a treatment regimen similar to that used clinically in patients with SCLC, once-daily oral administration of IPI-926 led to a statistically significant delay in tumor re-growth as compared to vehicle control.
Infinity plans to present additional preclinical data on IPI-926 at the American Association for Cancer Research-National Cancer Institute-European Organization for Research and Treatment of Cancer (EORTC) International Conference on Molecular Targets and Cancer Therapeutics to be held in Geneva, Switzerland in October 2008.
About the Hedgehog Pathway
The Hedgehog signaling pathway is highly active in regulating tissue and organ formation during embryonic development. However, abnormal activation of the Hedgehog pathway is believed to play a central role in the proliferation and survival of several types of cancers, including pancreatic, prostate, lung, breast, and certain brain cancers. In addition, recent evidence also suggests a role for the Hedgehog pathway in cancer stem cells, a subpopulation of self-renewing "progenitor-like" cells that are chemo-resistant and Hedgehog-dependent. Cancer stem cells may be responsible for tumor re-growth and progression, despite treatment with conventional chemotherapeutic agents.
About Infinity Pharmaceuticals, Inc.
Infinity is an innovative cancer drug discovery and development company seeking to discover, develop, and deliver to patients best-in-class medicines for the treatment of cancer and related conditions. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging cancer pathways. Infinity's two most advanced programs in Hsp90 inhibition and Hedgehog signaling pathway inhibition are evidence of its innovative approach to oncology drug discovery and development. For more information on Infinity, please refer to the company's website at http://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 statements regarding the utility of Hedgehog inhibitors, including IPI-926, in treating various types of cancer; future clinical trial activity of IPI-926; and the presentation of additional preclinical data on IPI-926. 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. In particular, management's expectations could 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; decisions made by EORTC and other organizations evaluating data for presentation or publication; Infinity's ability to obtain additional funding required to conduct its research, development and commercialization activities; unplanned cash requirements and expenditures; 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 June 30, 2008, as filed with the Securities and Exchange Commission on August 6, 2008. Further, 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.