TUSTIN, Calif., Aug. 11 PeregrinePharmaceuticals, Inc. (Nasdaq: PPHM) today announced that patient screeningand dosing has begun in a Phase II trial designed to evaluate the safety andefficacy of bavituximab in combination with chemotherapy in patients withadvanced breast cancer. The new trial is the second Phase II study evaluatingbavituximab in advanced breast cancer patients, and Peregrine also isconducting a third Phase II combination therapy trial of bavituximab innon-small cell lung cancer (NSCLC) patients. The primary objective of the newbreast cancer study is to assess the overall tumor response rate to thecombination of bavituximab with carboplatin and paclitaxel.
"The combination of bavituximab with the chemotherapy drugs carboplatinand paclitaxel performed well in an earlier Phase I study, and we look forwardto learning more about bavituximab's potential in this larger breast cancerstudy," said Steven W. King, president and CEO of Peregrine. "With three PhaseII studies now underway, we look forward to significant clinical data beinggenerated throughout the rest of this year."
In the trial's two-stage design, up to 15 patients with advanced breastcancer will be enrolled initially. The study will then be expanded up to atotal of 46 patients if promising results are observed. Secondary objectivesof the trial include measuring time to tumor progression, duration ofresponse, overall patient survival and safety parameters. Tumor response willbe evaluated using Response Evaluation Criteria in Solid Tumors (RECIST)parameters. Patients may continue to receive bavituximab alone aftercompletion of chemotherapy as long as the cancer does not progress and sideeffects are acceptable. The trial is being conducted in India according toInternational Conference on Harmonization (ICH) and Good Clinical Practices(GCP) standards.
Peregrine recently reported that a Phase II trial assessing thecombination of bavituximab and docetaxel in patients with metastatic breastcancer had achieved the pre-specified Stage A primary endpoint needed toexpand the trial to the second stage. Seven of the 14 evaluable patientsachieved partial tumor responses and seven had stable disease at week eightaccording to RECIST criteria.
"Bavituximab showed promising signs of anti-tumor activity in metastaticbreast cancer patients in combination with chemotherapy in a clinical study wehelped conduct last year," said Dr. Raghunadharao Digumarti, professor ofmedical oncology at the Nizams Institute of Medical Sciences in Hyderabad,India and a principal investigator of the bavituximab Phase II breast cancertrial. "We look forward to assessing the results from this trial in a largerpopulation of patients with breast cancer, the most commonly diagnosed cancerin women worldwide."
According to the World Health Organization, breast cancer is the mostcommonly diagnosed cancer in women, and is second only to lung cancer as aleading cause of female cancer deaths. The National Cancer Institute estimatesthat approximately 182,460 U.S. women will be diagnosed with breast cancer in2008 and 40,480 women will die of the disease.
Bavituximab is a monoclonal antibody that binds to the cellular membranecomponent phosphatidylserine (PS) that is usually located inside cells, butwhich becomes exposed on the outside of the cells that line the blood vesselsof tumors, creating a specific target for anti-cancer treatments. By bindingto PS, bavituximab is believed to help mobilize the body's immune system todestroy the tumor and the tumor blood vessels. Bavituximab currently is intwo separate Phase II combination therapy trials for the treatment of advancedbreast cancer and a Phase II combination therapy trial for the treatment ofnon-small cell lung cancer. Peregrine recently reported that a Phase II trialassessing the combination of bavituximab and docetaxel in patients withm