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Hedgehog Agonists Modulate Hair Growth; Preclinical Data Published in The Journal of Investigational Dermatology


CAMBRIDGE, Mass.-- Sept. 1, 2005 -- Curis, Inc. (NASDAQ: CRIS), a therapeutic drug development company, today announced the publication of data reporting on the therapeutic efficacy of one of Curis’ proprietary Hedgehog pathway activators in an adult animal model of hair growth. The results of the study show that a topically applied small molecule agonist of the Hedgehog signaling pathway can stimulate the transition of hair follicles from the resting to the growth stage of the hair cycle. The Hedgehog agonist induces hair growth and causes no other detectable short or long-term changes in the skin of the animals. This study also demonstrated that the Hedgehog agonist is active in human scalp in vitro as measured by Hedgehog pathway gene expression. The results suggest that topical application of a Hedgehog agonist could be effective in treating hair loss conditions, including male and female pattern hair loss. These results expand on those that were presented at the February 2005 Annual Meeting of the American Academy of Dermatology.

Curis’ Hedgehog agonist program was exclusively licensed to Wyeth Pharmaceuticals in January of 2004. Under the terms of the license agreement, Curis retained the right to develop Hedgehog agonists for topical treatment to stimulate hair growth. The license agreement was subsequently amended to broaden Curis’ development rights to include topical applications to treat or prevent skin diseases or disorders and Wyeth has approved a group of Hedgehog agonist compounds for use in Curis’ retained programs.

“We are encouraged by these preclinical results showing the utility of Hedgehog agonists to stimulate hair growth in an adult animal model. It is our goal to partner this program with another biotechnology company or a larger pharmaceutical company with expertise and skills in dermatological hair growth that complement our own in-house capabilities. Our collaboration strategy allows for the development of a broad portfolio of promising assets providing risk diversification with significant value potential,” said Daniel R. Passeri, President and Chief Executive Officer of Curis, Inc.

The article entitled, “Modulation of hair growth with small molecule agonists of the hedgehog signaling pathway” will appear in the October issue of The Journal of Investigational Dermatology. An online version of the article is available now at Authors of the paper include Rudolph D. Paladini, Jacqueline Saleh, Changgeng Qian, Guang-Xin Xu, and Lee L. Rubin, all of Curis, Inc.

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 and under development at Centocor, both subsidiaries of Johnson & Johnson), neurological disorders (under collaboration with Wyeth), hair growth, and cardiovascular disease. For more information, please visit the Curis web site at

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.


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