CAMBRIDGE, Mass., Feb. 9, 2009 (GLOBE NEWSWIRE) -- Infinity Pharmaceuticals,
Inc. (Nasdaq:INFI), an innovative cancer drug discovery and development company,
today announced the presentation of preclinical data from the natural product
foundation of IPI-926, Infinity's orally-available inhibitor of the Hedgehog
pathway, demonstrating significant inhibition of tumor growth in a primary
ovarian cancer model.
Data from the laboratory of Bo Rueda, Ph.D., Associate Professor, Department of
Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School and
Associate Director, Vincent Center for Reproductive Biology, Massachusetts
General Hospital, was introduced in an oral presentation entitled, "Hedgehog
inhibitor cyclopamine suppresses Gli1 expression and inhibits serous ovarian
cancer xenograft growth" last week at the 40th Annual Meeting on Women's Cancer
of the Society of Gynecologic Oncologists. The data show that treatment with
cyclopamine, the natural product foundation of IPI-926, in animals bearing
grafts of primary ovarian cancer resulted in significant tumor growth inhibition
compared to vehicle treated animals. Dr. Rueda's models of ovarian cancer are
derived from patient specimens that have not undergone prior tissue culture, and
are believed to reflect the clinical presentation of ovarian cancer.
Infinity's novel, oral, Hedgehog pathway inhibitor, IPI-926, is semi-synthetic
derivative of the natural product cyclopamine with superior drug-like
properties, including being 30 to 50 times more potent. In addition, IPI-926 has
demonstrated significant anti-tumor activity and excellent pharmaceutical
properties, including oral bioavailability, long plasma half-life and duration
of action, and dose-dependent inhibition of tumor growth, in a number of
preclinical models including pancreatic cancer, small cell lung cancer, and
medulloblastoma.
IPI-926 is currently being evaluated in a Phase 1 trial in patients with
advanced and/or metastatic solid tumors. The study is designed to evaluate the
safety, tolerability and pharmacokinetics of IPI-926, and to determine a
recommended dose and schedule for subsequent studies. Infinity will also
evaluate potential anti-tumor activity of IPI-926 and examine pharmacodynamic
markers of its biological activity.
Infinity anticipates publishing additional preclinical data with IPI-926 at the
2009 Annual Meeting of the American Association for Cancer Research (AACR) in
April 2009.
About IPI-926
IPI-926 is a novel, proprietary inhibitor of the Hedgehog signaling pathway
being evaluated in a Phase 1 clinical trial in patients with advanced solid
tumors. IPI-926 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. In preclinical
models, IPI-926 has demonstrated significant anti-tumor activity and excellent
pharmaceutical properties, including oral bioavailability, long plasma and tumor
half-life, and dose-dependent inhibition of tumor growth, in a number of
preclinical models.
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 registration statement on Form S-3 filed with the Securities and
Exchange Commission on January 9, 2009. 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.
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CONTACT: Infinity Pharmaceuticals, Inc.
Monique Allaire
617-453-1105
Monique.Allaire@infi.com
http://www.infi.com
