Peregrine Announces Initiation of Lung Cancer Investigator-Sponsored Trial
Peregrine Pharmaceuticals, Inc., has announced the initiation of an investigator-sponsored trial (IST) for patients with chemotherapy naive stage IV non-squamous non-small cell lung cancer (NSCLC). This Phase Ib trial will treat up to 25 front-line NSCLC patients with Peregrine's investigational monoclonal antibody bavituximab in combination with the chemotherapeutic agents pemetrexed and carboplatin.
"We are encouraged by the prior lung cancer data on bavituximab in combination with chemotherapy and look forward to evaluating the safety and potential efficacy of bavituximab in combination with pemetrexed and carboplatin as an additional therapeutic option in the front-line treatment setting," said Juneko E. Grilley-Olson, M.D., lead investigator of this trial and assistant professor of hematology and oncology at the University of North Carolina at Chapel Hill.
Grilley-Olson continued, "Chemotherapy has been shown to increase the exposure of phosphatidylserine (PS) on tumor blood vessel cells, upregulating the exposure of bavituximab's PS target. We are eager to evaluate this new combination therapy regimen for the treatment of this deadly form of cancer."
In a prior Phase II trial treating 49 front-line NSCLC patients with bavituximab in combination with a different chemotherapeutic regimen, carboplatin and paclitaxel, overall tumor response rate (ORR) was 43% as measured by RECIST criteria and median progression-free survival (PFS) was 6.1 months.
Currently, bavituximab is being evaluated in four randomized Phase II trials, including front-line NSCLC, second-line NSCLC, pancreatic cancer, and HCV and in two other investigator-sponsored trials in advanced liver cancer and HER2-negative metastatic breast cancer.
"This new IST is important as it augments our overall clinical experience in treating patients with bavituximab, especially as we conduct our two randomized Phase IIb trials in NSCLC," said Joseph S. Shan, vice president, clinical and regulatory affairs at Peregrine Pharmaceuticals. "We are excited to have Dr. Grilley-Olson and her team evaluate this therapeutic combination as an additional potential treatment combination for patients with metastatic lung cancer."