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news.Bavituximab, monoclonal antibody allows immune system to recognize and act on the tumor resulting in anti-cancer effects.
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Peregrine has highlighted the progress it has achieved in its Phase II program, assessing the combination of bavituximab and chemotherapy in three separate cancer trials. Bavituximab is a monoclonal antibody that allows the body’s own immune system to recognize and act on the tumor and its supporting blood vessels, resulting in anti-cancer effects.
Bavituximab is currently being tested in combination with chemotherapy in one Phase II trial in advanced lung cancer, and two Phase II trials in advanced breast cancer.
Phase II trial is evaluating bavituximab in combination with carboplatin and paclitaxel in non-small cell lung cancer (NSCLC) patients with locally advanced or metastatic disease. Almost 65% of evaluable patients in the initial cohort of 21 patients achieved an objective tumor response.
In evaluating bavituximab in combination with docetaxel in advanced breast cancer patients, 71% of evaluable patients demonstrated an objective tumor response.
In evaluating bavituximab in combination with carboplatin and paclitaxel in advanced breast cancer patients, 64% achieved an objective tumor response.
Data in all three studies surpassed pre-established criteria for expansion of patient enrollment.
The primary objective of these studies is to assess the overall patient response rate to the combination regimen of bavituximab and chemotherapy according to Recist criteria. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters.
Steven King, President and CEO of Peregrine, said, We believe this growing interest reflects our recent progress in successfully advancing all three Phase II bavituximab cancer trials, easily surpassing the pre-determined efficacy criteria needed to expand the trials to larger patient cohorts. The trials encompass different cancers and different chemotherapy regimens, yet in all three, preliminary data on tumor responses are very encouraging and compare well with historical experience with chemotherapy alone. With these encouraging results in hand, we look forward to sharing additional data on the entire clinical study populations in the second half of 2009.