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| Hedgehog Pathway Activation Promotes Tissue Protection and Repair in Cardiac Ischemia; Preclinical Data Published in Nature Medicine |
CAMBRIDGE, Mass., Oct 25, 2005 (BUSINESS WIRE) -- Curis, Inc. (NASDAQ: CRIS), a therapeutic drug development company, today announced the publication of data showing that stimulating the Hedgehog signaling pathway was therapeutically efficacious in preclinical models of both acute and chronic ischemic heart disease. Myocardial ischemia, the interruption of blood flow and oxygen to heart muscle, is the leading cause of heart attacks. In the U.S., approximately 1.1 million individuals experience new or recurrent myocardial infarctions each year and, of these, about 40% eventually develop congestive heart failure, a form of chronic heart disease. The research for these studies was performed in the laboratory of Dr. Douglas Losordo in the Division of Cardiovascular Research at the St. Elizabeth's Medical Center of Boston, Massachusetts. 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. In the reported animal studies, therapeutic activation of the Hedgehog pathway near the zone of ischemic damage in the heart appeared to protect heart cells from death, preserve heart muscle function, improve blood flow, and attract bone-marrow derived progenitor cells from the blood that help build new blood vessels. Activating the Hedgehog pathway appears to result in the coordinated release of various factors that promote these diverse protective and regenerative effects, which potentially could result in more robust and durable efficacy in the clinic than treatment with single factors alone. "This study adds to the growing body of preclinical data supporting the use of Hedgehog agonists to promote tissue repair post ischemia. Heart disease is one of the leading killers of Americans and although early, this data is encouraging that our novel approach could show significant promise. In keeping with our collaboration strategy, which allows for the development of a broad portfolio of promising assets providing significant value potential, we would plan to partner this program for human studies," said Daniel R. Passeri, President and Chief Executive Officer of Curis, Inc. Wyeth Pharmaceuticals has licensed rights from Curis for Hedgehog agonist compounds, including small molecule compounds, proteins and polypedtides for systemic treatment of diseases and disorders in humans, which includes systemic treatment of cardiovascular disease. In addition, as part of Curis' collaboration with Wyeth, Curis has retained the right to locally administer Hedgehog agonist compounds for the treatment of cardiovascular disease, including peripheral vascular disease and acute myocardial infarction, or heart attack. Wyeth has a right of first negotiation to obtain an exclusive license to the local cardiovascular applications. If Wyeth declines to exercise its option, or if Curis is unable to reach an agreement with Wyeth on terms within the contractually specified period, Curis is free to seek another collaborator for this program. Preclinical data relating to this program has been derived from studies conducted at Caritas St. Elizabeth's Medical Center in Boston, Massachusetts. The article entitled, "Sonic hedgehog gene therapy in myocardial ischemia: tissue repair through transient reconstitution of embryonic signaling" will appear in the November issue of Nature Medicine. An Advanced Online Publication of the article is available now at http://www.nature.com/nm/journal/vaop/ncurrent/index.html. The lead author on the paper is Dr. Kengo F. Kusano. 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 two collaborations with Genentech, one of which includes a co-development arrangement for a basal cell carcinoma product candidate that is currently in Phase I clinical trials), neurological disorders (under collaboration with Wyeth), hair growth (under collaboration with Procter & Gamble), kidney disease (licensed to Ortho Biotech Products and under development at Centocor, both subsidiaries of Johnson & Johnson), and cardiovascular disease. Curis also possesses robust small molecule drug screening technologies and preclinical scientific expertise that Curis believes it can use to create a sustainable drug candidate pipeline including, for example, its efforts in Spinal Muscular Atrophy (under sponsored research agreement with the Spinal Muscular Atrophy Foundation). 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 about Curis' drug discovery and development programs. Such statements 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: negative outcomes in our basal cell carcinoma product candidate Phase I clinical trial, adverse results in Curis' and its strategic partners' product development programs; difficulties or delays in obtaining or maintaining required regulatory approvals; 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 realigned business strategy; the risk that Curis does not obtain the additional funding required to conduct research and development of its product candidates and execute on its business plan; unplanned cash requirements and expenditures; risks relating to Curis' ability to enter into and maintain important strategic partnerships, including its ability to maintain its current collaboration agreements with Genentech, Ortho and Wyeth; the risk that competitors will discover and develop signaling pathway-based therapeutics faster and more successfully that 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 10-Q and any subsequent reports 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. |