Peregrine Receives FDA Approval to Proceed With Tarvacin Phase I Study

Peregrine Pharmaceuticals has received clearance from the FDA to move forward with its clinical program for Tarvacin, a novel anticancer agent.

The company and the FDA agreed upon the Phase I study protocol following an exchange of information and discussions centered on Tarvacin's novel mechanism of action and the best ways to monitor safety once patient treatment begins. During the discussions with the FDA, Peregrine had finalized the selection of clinical sites to participate in the study. Patient enrollment at each clinical site can begin pending internal review and approval of the protocol. Peregrine will submit the final revised protocol as agreed upon with the FDA and can initiate the study without waiting for FDA review.

The objectives of the Tarvacin Phase I clinical study are to determine the safety and tolerability of Tarvacin administered intravenously to patients with advanced cancer; to characterize the pharmacokinetic profile of Tarvacin; and to define the dose-limiting toxicities, maximum-tolerated dose and/or maximum-effective dose of Tarvacin. In addition, patients who demonstrate an objective response to therapy may be offered continued treatment on an extension protocol. Up to 28 patients with advanced solid tumors that no longer respond to standard cancer treatments will be enrolled at three clinical sites.