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Biotech / Medical : Kosan BioSciences -- KOSN

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From: scaram(o)uche7/11/2005 8:49:20 AM
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Infinity Initiates Phase I Clinical Trial of IPI-504 for Multiple Myeloma
Monday July 11, 8:33 am ET
-- Investigational compound moved from conception to the clinic in just over a year --

CAMBRIDGE, Mass., July 11 /PRNewswire/ -- Infinity Pharmaceuticals, Inc. today announced the initiation of a phase I clinical trial of IPI-504, the company's Heat Shock Protein 90 (Hsp90) inhibitor and lead investigational anticancer agent. Research shows that inhibition of Hsp90 forces cancer cells to "commit suicide" through a process of programmed cell death or apoptosis. IPI-504 is initially being developed as a potential treatment for patients with multiple myeloma and will subsequently be developed for additional hematologic (blood) cancers and solid tumor indications.
This open-label safety assessment phase I trial of IPI-504 will evaluate the potential anti-tumor activity and the tolerability of various doses in subjects with relapsed or relapsed, refractory multiple myeloma. Initial subjects in the study are being treated at St. Vincent's Comprehensive Cancer Center in New York under the direction of Sundar Jagannath M.D., Chief of the Multiple Myeloma Service.

"We are excited and encouraged to begin our first clinical trial of IPI- 504 and look forward to further exploring its use as a single agent and in combination with other chemotherapeutic agents to attack cancer cell survival," said Julian Adams, Ph.D., Chief Scientific Officer, Infinity. "A key advantage of the compound relative to other Hsp90 inhibitors is its intravenous administration to patients using a simple water-based formulation."

IPI-504 is an innovative and proprietary small molecule compound specifically designed to attack a cancer cell's machinery for maintaining protein homeostasis, the process by which cells continue the orderly formation and destruction of proteins. Infinity presented preclinical data on IPI-504 during the 96th Annual Meeting of the American Association for Cancer Research held in Anaheim, California in April 2005. In vitro studies demonstrate that IPI-504 binds to Hsp90 more tightly than 17-AAG. In addition, IPI-504 acting as a sole agent shows potent cytotoxic activity against multiple myeloma cells which are resistant to current therapies including bortezomib-resistant cells. When examined in vivo, IPI-504 demonstrated a 71% reduction in multiple myeloma tumor growth relative to controls in a preclinical xenograft model. It was also found to decrease serum Immunoglobulin lambda chain concentrations (similar to M protein in the human disease), enabling monitoring of disease burden with a surrogate marker. Furthermore, in vivo reduction in tumor growth was also observed in several other human xenograft models, including models of breast, prostate and ovarian cancer.

"The initiation of the IPI-504 clinical trial is a significant corporate milestone for Infinity," said Steve Holtzman, President and Chief Executive Officer, Infinity. "It marks the start of our commitment to bring innovative treatment options to healthcare providers and patients."

About Multiple Myeloma

Multiple myeloma is a progressive, incurable hematologic (blood) cancer characterized by the growth of specific cells in the blood called plasma cells. These cells are normally part of the immune system and make proteins called antibodies. In myeloma, plasma cells proliferate in the bone marrow which often results in extensive skeletal destruction and/or pathologic fractures, and low blood counts. In addition, they produce abnormally large quantities of proteins which lead to other clinical findings including kidney failure and may lead to increased susceptibility to infection. The Multiple Myeloma Research Foundation estimates the frequency of multiple myeloma as 4-5 new cases per 100,000 persons per year. In the United States approximately 50,000 people are living with multiple myeloma and roughly 15,000 new cases are diagnosed each year.

About Infinity Pharmaceuticals, Inc.

Infinity is a fully integrated, cancer drug discovery company focused on pathways of cancer cell survival. In addition, through select partnerships, Infinity's distinctive, proprietary collection of small molecules is being used against many of the world's most important diseases.

Editor's Note: This release is available on News & Events section of the Infinity website at ipi.com

Contacts:
Adelene Q. Perkins Paul Kidwell (media)
Chief Business Officer Kidwell Public Relations
Infinity Pharmaceuticals, Inc. 617-296-3854
617-453-1104 paul_kidwell@hotmail.com
Adelene.Perkins@ipi.com
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