Peregrine Completes Patient Enrollment In Bavituximab Trial

Published: 30-Jun-2009

To determine safety and tolerability of bavituximab in patients with advanced cancer

Peregrine has completed the patient enrollment in its US Phase I clinical trial, evaluating bavituximab as monotherapy in patients with advanced refractory cancers.

The objectives of this multi-center open label dose escalation study are: to determine the safety and tolerability of bavituximab in patients with advanced cancer, to characterize the pharmacokinetic profile of bavituximab, and to identify dose-limiting toxicities and the maximum tolerated dose and/or maximum effective dose.

In these patients, a maximum tolerated dose had not been reached even at the highest planned dose level. Peregrine has now begun designing additional bavituximab cancer trials based on findings from this Phase I study, and its Phase II combination therapy trials in breast and lung cancer.

The trial enrolled patients with breast, colorectal, pancreatic, liver, prostate, and head and neck cancers, as well as melanoma and mesothelioma.

Joseph Shan, Vice President of clinical and regulatory affairs, Peregrine, said: Completion of patient enrollment in this Phase I trial is a significant milestone for the bavituximab cancer program. We believe data from this study, along with our ongoing Phase II lung and breast cancer trials, set the stage for advancing the bavituximab oncology program into later-stage clinical studies.”

“The safety data collected from the diverse cancer types in this study are encouraging as we plan for expansion of the bavituximab cancer program in the coming year. We look forward to sharing more data from the ongoing cancer trials as patient treatment and follow-up continue in this study and in our three ongoing Phase II bavituximab cancer trials, he added.

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