(ChemotherapyAdvisor) – Clinical trials for oregovomab, a drug candidate for the treatment of advanced ovarian cancer, are now recruiting patients in the United States, according to news from the drug’s developer, Quest Pharmatech, Inc., Edmonton, Alberta, Canada. The news comes after the company received clearance from the United States Food and Drug Administration to initiate U.S. sites for an ongoing international Phase 2 clinical trial. According to the company’s website, this dosing study is powered to evaluate whether optimally dosed oregovomab in conjunction with front-line chemotherapy will generate the same or an improved immune and clinical response as seen in a previous Phase 2 clinical trials in a similar ovarian cancer patient population.
Oregovomab, a high affinity monoclonal antibody that targets the circulating tumor-associated antigen CA125, forms an antibody-antigen complex that is taken up by dendritic cells, which subsequently present the antigen fragments to T-cells, thus inducing an antitumor immune response.
Three U.S. centers have already been chosen for the clinical trials: Michiana Hematology and Oncology, South Bend, IN (Contact: Dr. Michael Method, Lead Investigator); University of Connecticut Health Center, Farmington, CT (Contact: Dr. Molly R. Brewer, Lead Investigator); and Stanford Cancer Institute at Stanford, CA (Contact: Dr. Jonathan S. Berek, Lead Investigator). Two-thirds of these U.S. centers have already received all necessary regulatory approvals and are now actively recruiting patients; the third center is awaiting approval from their institutional review board.
In their press release, Dr. Christopher Nicodemus, MD, FACP, Senior Advisor and Chairman of the Company’s Clinical Advisory Board commented: “A systematic study of combinatorial immunization strategies, such as the current trial, with its evidence-based preliminary observations, has the potential of revolutionizing cancer therapy and may lead to important commercial applications.”