Phase III agreement full text:
Peregrine Pharmaceuticals (Nasdaq: PPHM) announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Phase III registration trial design of the company's lead clinical immunotherapeutic candidate bavituximab in second-line non-small cell lung cancer (NSCLC). The trial design was supported by promising data from a Phase IIb trial in patients treated with bavituximab plus docetaxel. Final data from the study will be presented at the upcoming ASCO Annual Meeting on Saturday, June 1, 2013.
"We are very pleased with the outcome from this highly collaborative effort with the FDA which allows us to proceed with our proposed Phase III clinical trial," said Robert Garnick, Ph.D, head of regulatory affairs at Peregrine. "We believe this trial, when combined with bavituximab's supporting data to date, could be sufficient to support a future BLA submission."
The Phase III clinical trial will be a randomized, double-blind, placebo-controlled trial evaluating bavituximab plus docetaxel versus docetaxel alone enrolling approximately 600 patients at sites worldwide. The trial will enroll Stage IIIB/IV non-squamous, NSCLC patients who have progressed after standard front-line treatment. The primary endpoint of the trial will be overall survival (OS).
"The promising survival and safety data from the Phase IIb clinical trial in second-line NSCLC combined with the safety profile from over 400 patients treated to date with bavituximab provide strong support for this Phase III clinical trial," said Joseph Shan, vice president of clinical and regulatory affairs of Peregrine. "We look forward to finalizing the clinical protocol and initiating the global Phase III trial by year-end."
Bavituximab is a novel investigational immunotherapy that activates the maturation of dendritic cells and cancer-fighting (M1) macrophages leading to the development of cytotoxic T-cells that fight solid tumors. Bavituximab has been studied in 17 clinical trials including lung, breast, pancreatic, liver and rectal cancers. Data from three of these clinical trials will be presented at the ASCO Annual Meeting beginning June 1, 2013.
"This agreement on a Phase III trial design with the FDA is a critical milestone for the bavituximab program," said Steven King, president and chief executive officer of Peregrine. "We will now focus on starting the Phase III trial while continuing ongoing partnering discussions. With immunotherapies at the forefront of new approaches to treating cancer, we are well positioned with bavituximab's novel immune activation mechanism to help advance this rapidly evolving field."
