Biopharmaceutical company Peregrine Pharmaceuticals has reported positive top-line results of its phase lb open label trial of bavituximab in combination with chemotherapy.
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The trial was designed to assess the safety and tolerability of bavituximab in combination with common chemotherapy agents in advanced cancer patients with metastatic disease who had failed prior therapy. Patients in the trial were also assessed for tumor response.
In the trial, the safety profile of bavituximab in combination with chemotherapy appeared similar to that seen in advanced cancer patients undergoing chemotherapy alone, according to Peregrine. The combination of bavituximab and chemotherapy showed positive signs of clinical activity, achieving objective tumor response or stable disease in 50% of the patients who were evaluable for tumor response.
Patients receiving bavituximab in combination with gemcitabine demonstrated an even greater response, with 75% achieving an objective tumor response or stable disease, while 50% of patients receiving bavituximab with carboplatin/paclitaxel demonstrated an objective tumor response. Data from this study are being further analyzed to support the initiation of phase II cancer trials later this year.
Bavituximab is a monoclonal antibody that targets and binds to a phospholipid called phosphatidylserine, which is located on the inside of normal cells but which becomes exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anticancer treatments.