CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 9, 2006--Curis, Inc. (NASDAQ:CRIS - News), a therapeutic drug development company, today announced that Genentech has extended funding to support Curis personnel performing research services through December 2006, with an option to extend further research funding through June 11, 2007, if both parties agree. It is currently expected that Curis personnel would support the two companies’ ongoing research in the systemic Hedgehog antagonist program and development of xenograft models for use in other Genentech programs. Under the terms of the amendment that extends funding, these researchers could also support efforts on other collaborative programs between the two companies.
Genentech and Curis have done extensive preclinical work on orally bioavailable small molecule Hedgehog antagonists and continue to conduct studies to support possible future clinical testing of these molecules. Genentech is currently conducting preclinical studies that may support an Investigational New Drug (IND) application for this drug candidate for future clinical testing.
As part of this collaboration, a Phase I study of a small molecule antagonist of the Hedgehog pathway in basal cell carcinoma is currently ongoing. This is a double-blind, randomized, placebo-controlled study that began enrolling patients in the second quarter of 2005. The primary objective of this study is to obtain data about the preliminary safety and tolerability profile of a four-week regimen of the drug candidate. In addition, the companies will evaluate the clinical activity of the drug candidate, defining clinical activity as the complete eradication of the treated basal cell carcinoma lesion, which is determined by clinical and microscopic examinations of the lesions.
This study is enrolling a total of approximately 60 patients over three segments:
Segment 1, a dose-escalation segment in which patients are randomized to receive treatment at one of four dose levels Segment 2, a segment in which additional patients are treated at the highest dose from the dose-escalation segment (Segment 1) Segment 3, a pharmacodynamic segment to evaluate biologic activity of the molecule As previously announced, preliminary data from Segments 1 and 2 revealed no significant safety concerns and suggested some signs of activity, although there was less clinical activity observed than anticipated. Final data from all three segments is planned to be unblinded and analyzed in late 2006; Curis originally anticipated that data would be available in June 2006.
“Having data from all three segments will help to provide the information necessary to determine the activity of the molecule, as well as the validity of the target.” said Daniel R. Passeri, President and Chief Executive Officer of Curis, Inc.
About Curis
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 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’ expected timeline for the completion of its ongoing Phase I clinical trial. 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 including, among other things:
adverse results in Curis’ and its strategic collaborators’ and licensees’ drug discovery and product development programs; risks relating specifically to its lead Phase I clinical trial under co-development with Genentech, including the risk that the parties may not be able to complete enrollment in the time frame expected, if at all, or that the parties will experience lower than planned retention rates for the trial, adverse trial outcomes or the failure of the trial to achieve the desired level of clinical activity; 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
