The trial began 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, to establish the maximum tolerated dose and dose limiting toxicities and to characterize the pharmacokinetic and pharmacodynamic properties of the drug candidate. The initial objectives of the phase I clinical trial have been achieved and the Phase I clinical trial expansion cohort is expected to enroll additional patients.
Dan Passeri, president and CEO of Curis, said: “We are pleased that the Phase I systemic Hedgehog antagonist drug candidate has achieved its primary objectives and that Genentech has elected to initiate a Phase I expansion cohort.
“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.”