CAMBRIDGE, Mass., Mar 14, 2008 (BUSINESS WIRE) -- Curis, Inc. (NASDAQ: CRIS), a drug development company focused on developing novel targeted medicines primarily for cancer treatment, today announced that its collaborator Genentech provided an update on its Phase II clinical trial plans for GDC-0449. GDC-0449 is an orally-administered small molecule antagonist of Hedgehog signaling and is being developed pursuant to the parties' June 2003 collaboration agreement. Genentech also announced that it has seen partial responses in advanced basal cell carcinoma tumors in the ongoing Phase I clinical trial of GDC-0449. Curis anticipates that Genentech will present the Phase I data at an upcoming scientific conference.
Genentech stated that it plans to initiate three Phase II clinical trials of GDC-0449 in 2008, which include a trial in metastatic colorectal cancer during the first quarter of 2008 and trials in advanced basal cell carcinoma and in an undisclosed advanced solid tumor of epithelial origin during the second half of 2008.
"We are pleased that our collaborator Genentech has announced its plans to advance this Hedgehog antagonist into broad Phase II clinical testing. We are also very encouraged by Genentech's report of partial responses observed in advanced basal cell carcinoma in the ongoing Phase I clinical trial since we believe such responses provide early evidence of clinical activity with this molecule, which could potentially represent a way to block Hedgehog signaling in cancers that utilize the Hedgehog pathway," said Curis President and CEO Dan Passeri. "We look forward to updating you on these Phase II trials and also to sharing the broader Phase I data."
In connection with the treatment of the first patient in the Phase II colorectal cancer trial, Curis has the right to receive a $3 million cash milestone payment from Genentech. Curis also has the right to receive an additional $3 million cash payment upon initiation of the Phase II testing of the undisclosed advanced epithelial solid tumor. As announced previously, Curis has already received a $3 million cash milestone payment for the initiation of Phase II testing in advanced basal cell carcinoma. Curis received this payment upon initiation of an expansion cohort of the Phase I clinical trial in advanced basal cell carcinoma in October 2007, because Genentech had determined the Phase I expansion cohort satisfied the criteria for a Phase II clinical trial under the parties' collaboration agreement. Curis is eligible to receive additional payments upon the achievement of further development milestones in this indication.
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 Curis' website 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 without limitation: statements regarding Genentech's plans to initiate three Phase II clinical trials of GDC-0449, the Company's expectations with respect to its receipt of one or more milestone payments from Genentech in connection with Genentech's advancement of GDC-0449, and the Company's expectations regarding the potential clinical benefits of GDC-0449. 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 important factors that may cause 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 internal product development programs, including without limitation unplanned delays and/or failures in the Company's efforts to file an investigative new drug application and further advance its product candidate, CUDC-101, and the other programs under its targeted cancer drug development platform;
-- adverse results, delays and/or failures in the Hedgehog pathway antagonist program currently under clinical development by the Company's collaborator, Genentech, for which the Company may have no foreknowledge and over which the Company will have no control;
-- difficulties or delays in obtaining or maintaining required regulatory approvals for products being developed by the Company internally and through its collaboration with Genentech;
-- 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 the Company does not obtain the substantial additional funding required to conduct research and development of its product candidates;
-- 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 and which could also adversely affect the Company's estimated operating expenses for 2008 and beyond;
-- risks relating to the Company's ability to enter into and maintain important strategic collaborations, including its current collaboration with Genentech, and the risk that any such collaborators will not perform adequately;
-- competitive pressures; and
-- other risk factors identified in the Quarterly Report on Form 10-Q for the Quarter ended September 30, 2007 and other filings that the Company periodically makes with the Securities and Exchange Commission.
In addition, any forward-looking statements represent the views only as of today and should not be relied upon as representing the 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.
Michael P. Gray, 617-503-6632
Chief Financial Officer
mgray@curis.com