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Biotech / Medical : CRIS, Curis (formerly CBMI)
CRIS 1.280-10.5%2:40 PM EST

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From: Icebrg4/1/2005 8:38:56 AM
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Curis Announces IND Filing for Skin Cancer
Friday April 1, 8:30 am ET
Drug candidate for basal cell carcinoma under co-development by Genentech and Curis

CAMBRIDGE, Mass.--(BUSINESS WIRE)--April 1, 2005--Curis, Inc. (NASDAQ: CRIS - News), a therapeutic drug development company, today announced that Genentech, Inc. (NYSE: DNA - News) has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration to initiate human clinical investigation of a drug candidate for the topical treatment of basal cell carcinoma, the most common form of all human cancers with approximately 800,000 to 1,000,000 new cases reported every year in the U.S. This drug candidate, an antagonist of the Hedgehog signaling pathway, was discovered by Curis and is being co-developed through a collaboration between Genentech and Curis.

Daniel Passeri, President and Chief Executive Officer of Curis, said, "The filing of this IND is an important milestone for Curis. We are very pleased to be collaborating with Genentech on the development of this drug candidate. We believe that Genentech's proven expertise in the development of specifically targeted cancer therapeutics will provide an effective path forward for the Hedgehog pathway antagonist drug candidates."

Dr. Lee Rubin, Curis' Senior Vice President for Research and Chief Scientific Officer, said, "Preclinical research has suggested that the Hedgehog antagonists have the potential to selectively kill tumor cells while not harming adjacent normal cells. This selectivity contrasts with more traditional cancer treatments that often kill both cancer cells and normal cells. We believe that inhibition of the Hedgehog signaling pathway represents a truly novel approach for the treatment of certain cancers."

About the Genentech Curis Collaboration

In June 2003, Curis established a collaboration with Genentech for the continued development of a set of technologies based on inhibition of the Hedgehog signaling pathway, including small molecule Hedgehog pathway inhibitors. The initial focus of the collaboration was to identify lead clinical candidates for topical and systemic treatment of solid tumors. Numerous preclinical reports have linked abnormal activation of the Hedgehog pathway to the growth of several solid tumors, including basal cell carcinoma, pancreatic cancer, small cell lung cancer, prostate cancer, and others.

In March 2004, a lead clinical candidate was selected for the topical treatment of basal cell carcinoma. Under the terms of the collaboration, Curis retained a co-development option under which Curis may fund up to an equal share of the development costs and share in a commensurate portion of future net operating profits, if any, of clinical candidates that are topical formulations of compounds intended to treat basal cell carcinoma. In January 2005, Curis elected to exercise this co-development option. Curis' co-development right applies solely to the U.S. marketplace and includes applications for basal cell carcinoma and any other indications for which a topically administered clinical candidate may be developed.
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