Curis Updates Research on Hedgehog Agonist Protein Program for Cardiovascular Disease Indications
The Hedgehog pathway governs major aspects of heart and blood vessel development in the fetus and remains active in the adult for tissue maintenance and repair. When blood flow to the heart is blocked experimentally, which simulates an acute heart attack, the pathway is upregulated. Activating the Hedgehog pathway appears to result in the coordinated release of various factors that promote diverse protective and regenerative effects, which potentially could result in more robust and durable efficacy in the clinic than treatment with single factors alone.
Daniel Passeri, President and Chief Executive Officer of Curis, said, "We are very encouraged by the data generated by Wyeth and pleased with the progress made on the Shh protein cardiovascular program. The achievement of efficacy in an early preclinical cardiovascular disease model is a critical first step in validating the technology in the field of cardiovascular medicine."
About the Wyeth Collaboration
In January 2004, Curis entered into a collaboration agreement with Wyeth Pharmaceuticals under which Curis licensed its Hedgehog protein and novel small molecule Hedgehog pathway agonists (activators) to Wyeth for therapeutic applications in the treatment of neurological and other disorders. Under the terms of the collaboration, Wyeth paid Curis an up-front license fee and provided two years of initial research funding. Wyeth has twice extended its research funding, which currently extends until February 2008. In addition to research funding, if clinical development of any Hedgehog agonist technology-based products is successful, Wyeth is obligated to pay Curis cash payments for the achievement of certain development objectives as well as royalties on product sales. Excluding product royalties, the transaction has a potential value to Curis of more than $170 million, assuming at least two products are successfully developed. Curis and Wyeth have been developing small molecule Hedgehog agonist product candidates under this collaboration since 2004. The addition of a Shh protein cardiovascular program provides the second program under this collaboration for which Curis is entitled to receive cash payments that are contingent on the achievement of defined development objectives as well as royalties on product sales, should any occur.
About Curis, Inc.
Curis is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new medicines, primarily for cancer. In expanding its drug development efforts in the field of cancer through its Targeted Cancer Drug Development Platform, the Company is building upon its previous experiences in targeting signaling pathways in the areas of cancer, neurological disease and cardiovascular disease. For more information, visit www.curis.com.
Cautionary Statement: This press release and our website contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding Curis' belief that the Shh Protein could provide more robust and durable efficacy in the clinic than treatment with single factors alone and its belief that the achievement of efficacy in an early preclinical cardiovascular disease model is a critical first step in validating the technology in the field of cardiovascular medicine. Forward-looking statements used in this press release may contain the words "believes", "expects", "anticipates", "plans", "seeks", "estimates", "will", "may" or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other factors that may cause the Company's actual results to be materially different from those indicated by such forward-looking statements including, among other things:
-- adverse results, delays and/or failures in the Company's and its strategic collaborators' and licensees' product development programs, including without limitation adverse events, difficulties with patient enrollment and other unplanned delays in its Hedgehog pathway antagonist program currently under Phase I clinical development with Genentech and unplanned delays and/or failures in the Company's efforts to advance its Targeted Cancer Drug Development Platform programs;
-- risks that results demonstrated in preclinical studies, such as the preliminary results in the Company's cardiovascular program with Wyeth, will not be successfully replicated in future preclinical studies and/or clinical trials;
-- difficulties or delays in obtaining or maintaining required regulatory approvals for products being developed by the Company and its collaborators and licensees;
-- the Company's 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 the Company's 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 and execute its business plan;
-- unplanned cash requirements and expenditures which, among other things, could shorten the estimated period in which the Company will have cash to fund its operations;
-- risks relating to the Company's ability to enter into and maintain important strategic collaborations, and the risk that its current and future collaborators and licensees will not perform adequately, including such risks with respect to its current collaboration agreements with Genentech and Wyeth;
-- competitive pressures; and
-- other risk factors identified in the Company's most recent Current Report on Form 10-Q and its other 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. The Company 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.
Michael P. Gray, 617-503-6632
CFO & COO
Posted: August 2007
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