Curis, Inc. Provides Update On Basal Cell Carcinoma Phase I Clinical Trial; Company To Halt Skin Cancer Drug Trial In Current Formulation
Segment 1, a dose-escalation segment in which patients were randomized to receive treatment or placebo at one of four dose levels; Segment 2, a segment in which additional patients were randomized to the maximum tolerated dose from the dose-escalation segment (Segment 1); and Segment 3, a pharmacodynamic marker segment to evaluate biologic activity of the molecule. As previously announced, preliminary data from Segments 1 and 2 revealed no significant safety concerns in four weeks of topical treatment. Although histological clearance was observed in two subjects in Segment 1 of this Phase I trial, the clinical activity seen was far less than anticipated. The recent results from Segment 3 of the study showed that the formulation did not downregulate the targeted pharmacodynamic marker in this tumor, suggesting a possibility that the drug candidate may not be adequately penetrating human skin.
"We believe that downregulation of the pharmacodynamic marker we are targeting remains a valid approach for the treatment of basal cell carcinoma. We are working with Genentech to determine the next steps for this program and expect to make a decision in the coming months. We currently are sharing in the development costs for this clinical candidate and we expect that our co-development expenditures will decline in the short term pending determination of the future basal cell carcinoma development plan," said Daniel R. Passeri, President and Chief Executive Officer of Curis, Inc.
Mr. Passeri continued, "It is important to note that the systemic Hedgehog antagonist collaboration with Genentech for the treatment of systemic solid tumor cancers is an entirely different drug development program with different drug candidates. Pursuant to that collaboration, Genentech is currently conducting preclinical studies that may support an IND application for one or more drug candidates. Genentech will be required to make a milestone payment to Curis if it files an IND for a drug candidate."
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, 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 has elected to fund up to an equal share of the development costs and will 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. 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), neurological disorders (under collaboration with Wyeth), hair growth (under collaboration with Procter & Gamble), kidney and other diseases (licensed to Ortho Biotech Products and under development at Centocor, both subsidiaries of Johnson & Johnson), and cardiovascular disease. For more information, please visit the Curis web site at www.curis.com.
Cautionary Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements concerning Curis' plans and timeline to make a decision about possible future development alternatives of the basal cell carcinoma development program and its belief that the molecular markers it is targeting remain a valid approach to treating BCC. 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, Wyeth, and Procter & Gamble as well as its license agreement with Ortho Biotech Products; 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.
Contact: For Curis, Inc. Michael P. Gray, 617-503-6632 Chief Financial Officer or Megan Burns, 617-503-6658 Director, Corporate Communications
Source: Curis, Inc.