The multi-center trial is expected to begin enrolling patients once the protocol regulatory review is completed.
The trial has a two-stage design. Up to 21 NSCLC patients will be enrolled initially and the study will be expanded up to a total of 49 patients if positive results are observed in the first cohort.
The primary objective of the Phase II study is to assess overall response rate to the combination of bavituximab and chemotherapy. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. Patients will receive up to six cycles of chemotherapy with weekly administration of bavituximab until their cancer progresses.
Bavituximab is a monoclonal antibody believed to help mobilize the body’s immune system to destroy the blood vessels needed for tumor growth and spread. In a phase Ib trial to assess its safety in combination with common chemotherapy agents in advanced cancer patients with metastatic disease, bavituximab plus chemotherapy appeared to have a safety profile consistent with chemotherapy alone and showed positive signs of clinical activity, achieving objective response or disease stabilization in 50% of the evaluable patients.
“We look forward to assessing its potential in this larger trial in patients with non-small cell lung cancer, a condition that currently lacks effective treatment options,” said Steven King, president and CEO of Peregrine.
Bavituximab is currently in clinical trials in the US in patients with advanced solid tumors and in patients co-infected with HCV and HIV.