Curis, Inc. Announces Dosing of First Patient in Hedgehog Antagonist Phase I Clinical Trial

Trial tests safety of systemic administration of a Hedgehog antagonist in solid tumor cancers

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 31, 2007--Curis, Inc. (NASDAQ: CRIS), 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."

http://phx.corporate-ir.net/phoenix.zhtml?c=123198&p=irol-newsArticle&t=Regular&id=956196&

Hedge,

Do you know when we can expect any updates on the trial?

Hi Peter,

I think the last presentation said by the end of the year.

Try to google "GDC0449"

Application Number: NA00007667 entitled: " Open-Label, Ph.I Study of Systemic Hedgehog Pathway Antagonist, GDC0449, In Patients with Locally Advanced or ...

Don't know much else besides that...