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Biotech / Medical : CRIS, Curis (formerly CBMI) -- Ignore unavailable to you. Want to Upgrade?

To: nigel bates who wrote (600)	1/31/2007 8:13:18 AM
From: Icebrg	Respond to of 668

Curis, Inc. Announces Dosing of First Patient in Hedgehog Antagonist Phase I Clinical Trial Wednesday January 31, 8:00 am ET Trial tests safety of systemic administration of a Hedgehog antagonist in solid tumor cancers CAMBRIDGE, Mass.--(BUSINESS WIRE)--Curis, Inc. (NASDAQ: CRIS - News), a therapeutic drug development company focusing on cancer, neurological and dermatological disease indications, announced today that Genentech, a collaborator, has treated the first patient in a Phase I clinical trial of a systemically administered small molecule Hedgehog antagonist for testing in advanced cancer. The Phase I trial is designed as an open-label study 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 and to establish the maximum tolerated dose and dose limiting toxicities. The trial is expected to enroll approximately 50 patients spread across several dose-escalating cohorts. The successful completion of the Phase I trial will be dependent upon, among other things, the patient enrollment rate as well as the number of patients that will ultimately need to be treated to achieve the Phase I trial objectives. "We are proud that this drug candidate has achieved this important milestone in what we believe is the first systemically administered Hedgehog antagonist tested in a clinical setting," said Curis President and CEO Dan Passeri. "Cancer remains a major unmet medical need. It is the second leading cause of death in the United States, with an estimated 1.4 million new cases of cancer per year and an estimated 565,000 deaths. Published reports cite the Hedgehog pathway as potentially implicated in various cancers, including breast, colorectal, esophageal, pancreatic, prostate and small cell lung cancers, among others. While we realize that we are in only the first phase of human clinical testing, we are hopeful that our Hedgehog antagonist technologies may one day provide a therapeutic benefit to cancer patients." In October 2006, Genentech filed an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) to initiate Phase I clinical testing of this small molecule drug candidate. Under the terms of the parties' June 2003 collaboration agreement, Genentech previously paid Curis a $3 million cash payment after filing the IND application for the drug candidate. Should this drug candidate successfully continue its development into subsequent stages of clinical testing and regulatory approval, Curis would be eligible to receive additional cash payments. In addition, in the event the drug candidate is successfully commercialized, Curis would be eligible to receive royalties on product sales. About the Genentech Curis Collaboration In June 2003, Curis and Genentech entered into a collaboration for the development of Hedgehog pathway inhibitors, also known as antagonists, with a current focus on the clinical testing of these drug candidates in a variety of cancer types. Numerous preclinical reports have linked abnormal activation of the Hedgehog pathway to the growth of several cancers.