Health & Fitness
Health and Fitness
Health and Fitness
Mon, January 19, 2009
Fri, January 16, 2009
Thu, January 15, 2009
Curis Announces Genentech?s Expected Initiation of Pivotal Phase II Trial in Advanced Basal Cell Carcinoma with Hedgehog Pathwa
CAMBRIDGE, Mass.--([ BUSINESS WIRE ])--Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation proprietary targeted medicines for cancer treatment, today announced that its collaborator Genentech has indicated that it expects to initiate in January 2009 a pivotal Phase II clinical trial of GDC-0449, an orally-administered small molecule Hedgehog Pathway Inhibitor, as a single-agent therapy for patients with metastatic or locally advanced basal cell carcinoma (BCC). Under the companies' collaboration agreement, Curis will receive a $6 million cash payment from Genentech following initiation of this pivotal trial.
"The expected near-term initiation of this pivotal trial represents a significant development milestone for GDC-0449 in metastatic and locally advanced BCC and, we believe, builds upon the strong Phase I safety and efficacy data demonstrated by the drug, which showed clinical benefit in a substantial proportion of advanced BCC patients," said Curis President and CEO Dan Passeri. "We are pleased that our collaborator Genentech has worked with the FDA on the study design for this pivotal Phase II trial in advanced basal cell carcinoma. There is currently no standard of care for patients with these types of BCC and this pivotal trial is designed so that its data, if positive, may serve as the basis for NDA submission by Genentech. We look forward to providing further updates on the progress of this trial in the future."
Genentech expects to evaluate GDC-0449 in approximately 100 patients with metastatic or locally advanced BCC in a global single-arm, two-cohort clinical trial. One cohort includes all patients with histologically-confirmed, RECIST measurable metastatic BCC. The second cohort includes histologically-confirmed locally advanced BCC that is considered inoperable by the treating physician. All patients will receive a daily oral dose of GDC-0449. Trial details are expected to be posted at ClinicalTrials.gov prior to first patient enrolled in this trial.
"In addition to the near-term advancement of this promising clinical candidate, this pivotal trial initiation has added significance because it provides Curis with $6 million in non-dilutive cash that, when added to our existing capital, is sufficient to fund our currently-planned operations into mid-2010," said Curis Chief Operating and Chief Financial Officer Mike Gray. "This additional capital allows us to continue to execute our strategy of seeking to enter into collaborations around CUDC-305, our Hsp90 inhibitor, and CUDC-101, our first-in-class HDAC/EGFR/Her2 inhibitor, which we expect will both provide value to our shareholders while also reducing the financial risk of developing our assets independently."
About the Curis-Genentech Collaboration
Under the ongoing collaboration agreement between Genentech and Curis, GDC-0449 was discovered by Genentech and was jointly validated through a series of preclinical studies. Genentech and Roche collaborate on the clinical development and commercialization of GDC-0449. Curis is eligible to receive cash payments upon successful achievement of certain clinical development and regulatory approval milestones and royalties upon commercialization of GDC-0449.
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 for cancer. In expanding its drug development efforts in the field of cancer through its targeted cancer drug development platform, Curis is building upon its previous experiences in targeting signaling pathways for the development of next generation targeted cancer therapies. 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 the potential benefits ofGDC-0449 and the timetable and prospects for its further development and commercialization..The Company may usewords such as "believes", "expects", "anticipates", "plans", "seeks", "estimates", "will", "may" or similar expressions to identify these forward-looking statements.There are important factors that may cause actual results to be materially different from those indicated by such forward-looking statements including, among other things, risks relating to: the potential for adverse results, delays and/or failures in the Company's targeted cancer drug development program, including without limitation unplanned delays and/or failures in its clinical trial of CUDC-101 and its ongoing preclinical studies of CUDC-305; the success of the Company's collaboration with Genentech, including the risks that Genentech may experience adverse results, delays and/or failures in the Hedgehog Pathway Inhibitor program currently under clinical development and that the Company may have no control over, or foreknowledge of, the progress of this program; difficulties or delays in obtaining or maintaining required regulatory approvals for products under development both internally and through the Genentech collaboration; the Company's ability to obtain or maintain necessary intellectual property protection; adverse changes in the Company's ability to successfully execute its business plan, includingthe Company's ability to obtain the substantial additional funding required for such execution; 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 planned collaborations and maintain its current collaborations with Genentech; and competitive pressures.The Company also faces other risk factors identified in the Quarterly Report on Form 10-Q for the quarter ended September 30, 2008 and other filings that itperiodically makes 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 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.
