Morphotek and Eisai Announce FDA SpecialProtocol Assessment (SPA) for Phase III Trial Evaluating Farletuzumab inRelapsed Ovarian Cancer
Mon, 03/23/2009 - 5:09am
Morphotek(R), Inc., a subsidiary ofEisai Corporation of North America, announced today that the U.S. Food andDrug Administration (FDA) has agreed to and approved the design of a single,pivotal, Phase III clinical trial evaluating farletuzumab (also known asMORAb-003) in platinum-sensitive ovarian cancer patients experiencing theirfirst relapse. The agreement was made under the Special Protocol Assessment(SPA) procedure. "We are pleased that the FDA has approved the protocol for this Phase IIIstudy of farletuzumab in first-relapsed, platinum-sensitive ovarian cancer,"stated Martin D. Phillips, M.D., Chief Medical Officer of Morphotek."Physicians and patients do not have many good choices for treating ovariancancer at this stage, and we are hopeful that some day farletuzumab mayprovide an option for ovarian cancer patients and their caregivers."Morphotek is currently concluding a Phase II trial with farletuzumab as asingle-agent and in combination with standard-of-care chemotherapy(carboplatin and taxane) in platinum-sensitive ovarian cancer patientsexperiencing a first relapse of their disease. The trial was designed tomeasure objective rate of response, and to compare the length of a patient'ssecond remission with her first remission. Interim results from the studydemonstrated an encouraging rate of durable objective response in patients oncombination therapy. These findings prompted pursuit of a definitive pivotalstudy to evaluate the capacity of farletuzumab to benefit patients withovarian cancer in a rigorously controlled manner. The Phase III study, the design of which was agreed to by FDA, will assessthe capacity of farletuzumab to extend progression free survival and overallsurvival in combination with carboplatin and taxane at two different doselevels of farletuzumab. The study will be conducted as a randomized,double-blind, placebo-controlled trial. Morphotek expects to enroll up to 900subjects in this clinical study that will be conducted globally at sites inNorth America, South America, Europe, Australia and Asia."Ovarian cancer is a disease that is devastating to the lives of patientsand caregivers," said Nicholas Nicolaides, Ph.D., President and ChiefExecutive Officer at Morphotek. "The agreement reached in the SPA process forfarletuzumab's Phase III trial may bring us one step closer to providing hopein their lives and further exemplifies our human health care (hhc) mission tobring treatments to the people who need them most." Farletuzumab is a monoclonal antibody that binds to and blocks thefunction of folate receptor alpha (FRA), a cell surface protein on tumor cellsthat confers a growth advantage to tumorigenic cells in vitro. FRA has beendemonstrated by several independent studies to be expressed on ovarian cancercells. Preclinical data support the theory that farletuzumab achieves itspharmacological effect by two mechanisms: first, by the capacity offarletuzumab to block signaling inside cancer cells and, second, bystimulating the patient's immune system to attack and destroy the FRApositive-tumor cells. The pre-cursor to farletuzumab was originally developedby Dr. Lloyd Old at the Ludwig Institute for Cancer Research applying hispioneering work that employed whole cell immunization of tumors to identifycell surface factors. These efforts led to the development of a panel of novelantibodies that can recognize tumor cell surface antigens as well as tumorstromal cell surface antigens. Morphotek licensed the antibody and improved itusing the company's proprietary morphogenics technology. Ovarian cancer, which ranks fifth as the cause of cancer deaths in women,usually grows asymptomatically before it is discovered. The National CancerInstitute estimates that there were 21,650 new cases of ovarian cancer in thiscountry in 2008 and 15,520 deaths because of the disease. In Europe, it isestimated that there are 61,000 cases of ovarian cancer each year.