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Peregrine Pharmaceuticals To Initiate Bavituximab Phase II Trial In Lung Cancer Patients

Armen Hareyan's picture

Peregrine Pharmaceuticals has submitted a clinical protocol for a Phase II trial of bavituximab in combination with chemotherapy in patients with non-small cell lung cancer.

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 patientsurvival and safety parameters. Patients will receive up to six cycles of chemotherapy with weekly administration of bavituximab until their cancer progresses.

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"Submitting this Phase II clinical protocol represents a significant milestone for the bavituximab cancer program," said Steven W. King, president and CEO of Peregrine. "This trial builds on data generated from a recently completed Phase Ib clinical study in which bavituximab was administered in combination with chemotherapy, including carboplatin and paclitaxel. Results from that study indicated that the combination of bavituximab with paclitaxel and carboplatin was particularly promising, with encouraging signs of anti-tumor activity and a safety profile that appeared to be consistent with chemotherapy alone. 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."

Tumor response will be evaluated every other month using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. The trial is being conducted according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) guidelines.

Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine (PS), normally located inside normal cells, but which becomes exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anti-cancer treatments.

Bavituximab is 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. Bavituximab is currently in clinical trials in the U.S. in patients with advanced solid tumors and in patients co-infected with HCV and HIV.