Curis Announces Dosing of First Patient in Phase I Clinical Trial for Basal Cell Carcinoma
[Somewhat dated, but still.
A placebo controlled cancer trial. Something one doesn't come across very often].
CAMBRIDGE, Mass.--(BUSINESS WIRE)--June 8, 2005--Curis, Inc. (NASDAQ: CRIS), a therapeutic drug development company, today announced that the first patient in the basal cell carcinoma (BCC) Phase I trial has been dosed. This Phase I clinical trial is being conducted by Genentech (NYSE: DNA) and Curis. This drug candidate, a topical antagonist of the Hedgehog signaling pathway, was discovered by Curis and is being co-developed through a collaboration between Genentech and Curis. The Phase I study is a double-blind, randomized, placebo-controlled study that will enroll approximately 66 subjects with a single or multiple basal cell carcinoma. The study will be conducted at approximately ten investigational sites in the United States. The primary outcomes measured in this trial will be the safety and tolerability of a multi-dose regimen of the Hedgehog antagonist.
"The start of this Phase I trial is the first step toward evaluating whether this drug candidate may provide an alternative to surgical treatment for skin cancer, the most common form of all human cancers, which affects nearly a million people in the U.S. alone each year. This trial also represents a significant corporate milestone for Curis as it is the first of what we expect will be several upcoming clinical trials over the next two years. We're excited about the combination of Genentech's well-documented expertise in oncology and the encouraging preclinical results we have seen for this Hedgehog antagonist. We expect to be able to report results of this Phase I clinical trial in 2006," said Daniel R. Passeri, President and Chief Executive Officer of Curis, Inc.
About the Genentech Curis Collaboration
In June 2003, Curis established a collaboration with Genentech for the continued development of Hedgehog pathway inhibitors. The focus of the collaboration is to identify lead clinical candidates for topical and systemic treatment of solid tumors. Numerous preclinical reports have linked abnormal activation of the Hedgehog pathway to the growth of several solid tumors, including basal cell carcinoma, medulloblastoma, pancreatic cancer, small cell lung cancer, prostate cancer, and others.
In March 2004, a lead clinical candidate was selected for the topical treatment of basal cell carcinoma. Under the terms of the collaboration, Curis retained a co-development option under which Curis may fund up to an equal share of the development costs and share in a commensurate portion of future net operating profits and losses, if any, of clinical candidates that are topical formulations of compounds intended to treat basal cell carcinoma. In January 2005, Curis elected to exercise this co-development option. Curis' co-development right applies solely to the U.S. marketplace and includes applications for basal cell carcinoma and any other indications for which a topically administered clinical candidate may be developed. |
