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 US. 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 US alone each year. We expect to be able to report results of this phase I clinical trial in 2006,” said Daniel Passeri, president and CEO of Curis.
The first dosing comes a month after the FDA accepted Genentech’s investigational new drug application to initiate the phase I clinical trial.