Peregrine cleared to proceed with Tarvacin program

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. Peregrine will submit the final revised protocol as agreed upon to the FDA and can now 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; characterize its pharmacokinetic profile and; define its dose-limiting toxicities, maximum tolerated dose and/or maximum effective dose.

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 for the trial.