Curis, Inc. Reports Decision to Advance a Systemically Administered Hedgehog Antagonist into Phase II Clinical Testing
Wednesday December 12, 8:00 am ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Curis, Inc. (NASDAQ: CRIS - News), a drug development company focused on seeking to develop proprietary targeted medicines primarily for cancer treatment, today announced that its collaborator, Genentech, has notified Curis of its decision to progress a systemically administered Hedgehog antagonist drug candidate into Phase II clinical testing in the first half of 2008. The drug candidate will be evaluated in one or more solid tumor indications. Upon Phase II initiation, Curis will be eligible to receive additional cash milestone payments from Genentech under the parties’ June 2003 collaboration agreement. Should the current drug candidate successfully continue its development into subsequent stages of clinical testing and regulatory approval, Curis would be eligible to receive additional cash milestone payments. In addition, in the event the drug candidate is successfully commercialized, Curis would be eligible to receive royalties on product sales.
“We are pleased with Genentech’s decision,” said Curis President and CEO Daniel R. Passeri, MSc., J.D. “This represents an important development for Curis as our business model and portfolio continue to evolve. We continue to remain optimistic about our Hedgehog antagonist drug candidate, and look forward to providing further updates on this program upon initiation of Phase II clinical testing.”
About the Hedgehog Antagonist Program
In June 2003, Curis and Genentech entered into a collaboration for the development of Hedgehog pathway antagonists based upon Curis’ technologies with a current focus on the clinical testing of a drug candidate in a variety of cancer types. Numerous preclinical reports have linked abnormal activation of the Hedgehog pathway to the growth of several cancers.
Pursuant to the collaboration, in January 2007, Genentech began a Phase I clinical trial of a systemic Hedgehog antagonist in patients with locally advanced or metastatic cancers that are refractory to standard therapy or for whom no standard therapies exist. The primary objectives of the Phase I trial are to evaluate the safety and tolerability of escalating doses of the Phase I molecule, to establish the maximum tolerated dose and dose limiting toxicities and to characterize the pharmacokinetic and pharmacodynamic properties of the drug candidate. In October 2007, Genentech notified Curis that the initial objectives of the Phase I clinical trial were achieved and Genentech initiated a Phase I clinical trial expansion cohort to enroll additional patients in a specific cancer indication for preliminary signs of clinical response as well as the continued accumulation of Phase I safety data. In accordance with the terms of the parties’ June 2003 collaboration agreement, Curis received a $3 million cash milestone payment upon the initiation of the expansion cohort because Genentech determined that the Phase I clinical trial expansion cohort satisfied the criteria for a Phase II clinical trial under the agreement. |
