10.16.07
Genentech has initiated an expansion cohort in Phase I trial of a Hedgehog antagonist, triggering a $3 million cash payment to Curis, Inc. under the companies' June 2003 collaboration agreement. The Phase I trial expansion satisfies the criteria for a Phase II trial.
Genentech began the open-label Phase I trial in January 2007 to study a systemic Hedgehog antagonist in patients with locally advanced or metastatic cancers that have not responded to standard therapy or for whom no standard therapies exist. The primary objectives of the trial are to evaluate the safety and tolerability of escalating doses of the drug, to establish the maximum tolerated dose and dose limiting toxicities and to characterize pharmacokinetic and pharmacodynamic properties. The Phase I trial objectives have been achieved and the trial expansion cohort is expected to enroll additional patients.
"We are pleased that the Phase I systemic Hedgehog antagonist drug candidate has achieved its primary Phase I trial objectives and that Genentech has elected to initiate a Phase I expansion cohort," said Curis president and chief executive officer Dan Passeri. "While we realize that we are still in an early phase of human clinical testing, we continue to remain optimistic that this Hedgehog antagonist drug candidate may provide an effective therapeutic benefit to cancer patients in the future. We are also pleased with the receipt of $3 million in additional capital."
Genentech began the open-label Phase I trial in January 2007 to study a systemic Hedgehog antagonist in patients with locally advanced or metastatic cancers that have not responded to standard therapy or for whom no standard therapies exist. The primary objectives of the trial are to evaluate the safety and tolerability of escalating doses of the drug, to establish the maximum tolerated dose and dose limiting toxicities and to characterize pharmacokinetic and pharmacodynamic properties. The Phase I trial objectives have been achieved and the trial expansion cohort is expected to enroll additional patients.
"We are pleased that the Phase I systemic Hedgehog antagonist drug candidate has achieved its primary Phase I trial objectives and that Genentech has elected to initiate a Phase I expansion cohort," said Curis president and chief executive officer Dan Passeri. "While we realize that we are still in an early phase of human clinical testing, we continue to remain optimistic that this Hedgehog antagonist drug candidate may provide an effective therapeutic benefit to cancer patients in the future. We are also pleased with the receipt of $3 million in additional capital."