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Curis Announces U.S. Food and Drug Administration Acceptance of Application to Initiate Skin Cancer Phase I Clinical Trial
CAMBRIDGE, Mass., May 04, 2005 (BUSINESS WIRE) --
Curis, Inc. (NASDAQ: CRIS), a therapeutic drug development company, today announced that an Investigational New Drug (IND) application filed by its collaborator Genentech, Inc. (NYSE: DNA) has been accepted by the U.S. Food and Drug Administration. This acceptance provides approval for Genentech to initiate a Phase I clinical trial of a drug candidate for the topical treatment of basal cell carcinoma. Basal cell carcinoma is 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 is an antagonist of the Hedgehog signaling pathway that was discovered by Curis and is being co-developed through a collaboration between Genentech and Curis.
About the Genentech Curis Collaboration
In June 2003, Curis established a collaboration with Genentech for the continued development of Hedgehog pathway inhibitors. The focus of the collaboration is 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, medulloblastoma, 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 and losses, 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.
About Curis, Inc.
Curis, Inc. is a therapeutic drug development company. The Company's technology focus is on regulatory pathways that control repair and regeneration. Curis' product development involves the use of proteins or small molecules to modulate these pathways. Curis has successfully used this technology and product development approach to produce several promising drug product candidates in the fields of cancer (under collaboration with Genentech, which also includes a co-development arrangement for a basal cell carcinoma product candidate), kidney disease (licensed to Ortho Biotech Products, a subsidiary of Johnson & Johnson), neurological disorders (under collaboration with Wyeth), hair growth, and cardiovascular disease. For more information, please visit the Curis web site at www.curis.com .
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements concerning Curis' plans with respect to its product development programs and the potential effectiveness of its technologies under development. Forward-looking statements used in this press release may contain the words "believes", "expects", "anticipates", "plans", "seeks", "estimates" or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other factors that may cause Curis' actual results to be materially different from those indicated by such forward-looking statements. Actual results can be affected by a number of important factors including, among other things: adverse results in Curis' and its strategic collaborators' and licensees' product development programs; difficulties or delays in obtaining or maintaining required regulatory approvals for products being developed by Curis and its collaborators and licensees; Curis' ability to obtain or maintain the patent and other proprietary intellectual property protection necessary for the development and commercialization of products based on its technologies; changes in or Curis' inability to execute its business plan; the risk that Curis does not obtain the additional funding required to conduct research and development of its product candidates, fund its co-development obligations under its collaboration with Genentech and execute its business plan; unplanned cash requirements and expenditures; risks relating to Curis' ability to enter into and maintain important strategic collaborations, including its ability to maintain its current collaboration agreements with Genentech, Ortho Biotech Products and Wyeth; the risk that competitors will discover and develop signaling pathway-based or other competing therapeutics faster and more successfully than Curis and its collaborators are able to; and other risk factors identified in Curis' most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent reports periodically filed with the Securities and Exchange Commission. In addition, any forward-looking statements represent the Company's views only as of today and should not be relied upon as representing its views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise.
SOURCE: Curis, Inc.
Curis, Inc.
Michael P. Gray, 617-503-6632
Chief Financial Officer
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Copyright Business Wire 2005
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