TUSTIN, Calif., Feb. 12 PeregrinePharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceuticalcompany developing targeted therapies for the treatment of cancer andhepatitis C virus infection (HCV), today announced that patient dosing hasbegun in its clinical trial designed to evaluate the safety and efficacy ofbavituximab in combination with chemotherapy in patients with advanced breastcancer. The primary objective of the study is to assess the overall responserate to the combination of bavituximab with docetaxel, a chemotherapy drugcommonly used in breast cancer. The multicenter clinical trial is beingconducted in the Republic of Georgia.
"We are now seeing good overall momentum in our bavituximab Phase IIcancer program, and we are very pleased that our clinical colleagues in Europehave been so efficient in rapidly moving from protocol approval to trialinitiation to patient dosing," said Steven W. King, president and CEO ofPeregrine. "We are optimistic that all three bavituximab Phase II cancertrials will proceed well in the coming months and we look forward to reportingon our progress later 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 objectivesinclude measuring time to tumor progression, duration of response, overallpatient survival and safety parameters. Patients may continue to receivebavituximab alone after completion of chemotherapy as long as the cancer doesnot progress and side effects are acceptable.
"Bavituximab represents a novel strategy for the treatment of cancer thathas demonstrated encouraging potential in initial clinical studies," saidDavid Tabagari, M.D., Ph.D., the head of Medulla Immunotherapy andChemotherapy Clinic and principal investigator of the bavituximab breastcancer trial being conducted in the Republic of Georgia. "We are pleased tohave the opportunity to conduct the first Phase II trial of this potentiallyvaluable new approach to treating cancer."
Tumor response in this study will be evaluated using Response EvaluationCriteria in Solid Tumors (RECIST) parameters. The trial is being conductedaccording to International Conference on Harmonization (ICH) and Good ClinicalPractices (GCP) standards.
The National Cancer Institute estimates that approximately 178,480 U.S.women were diagnosed with cancer of the breast in 2007 and about 40,460 womendied of the disease. According to the World Health Organization, breastcancer is the most commonly diagnosed cancer in women, and is second only tolung cancer as a leading cause of female cancer deaths.
Bavituximab is a monoclonal antibody that binds to a phospholipid calledphosphatidylserine that is usually located inside normal cells, but whichbecomes exposed on the outside of the cells that line the blood vessels oftumors, creating a specific target for anti-cancer treatments. Bavituximab isbelieved to help mobilize the body's immune system to destroy the bloodvessels needed for tumor growth and spread. In a Phase lb pilot trial inadvanced cancer patients, bavituximab plus chemotherapy appeared to have asafety profile consistent with chemotherapy alone and showed positive signs ofclinical activity, achieving objective response or disease stabilization in50% of the evaluable patients. Peregrine has recently received regulatoryapproval to conduct three Phase II trials to study the anti-tumor effects ofbavituximab in combination with chemotherapy. These include two breast cancerprotocols and a non-small cell lung cancer protocol testing bavituximab incombination with chemotherapy. The first bavituximab breast cancer trial isnow underway and the two other trials are expected to begin soon. Bavituximabis in clinical trials in the U.S. in patients with advance