Morphotek(R), Inc. and Eisai Corporation of North America Announce FDA Special Protocol Assessment (SPA) for Phase III Trial Evaluating Farletuzumab in Relapsed Ovar...( EXTON Pa. March 23 /- Morphotek(R) ...),Health

EXTON, Pa., March 23 /PRNewswire/ -- Morphotek(R), Inc., a subsidiary of Eisai Corporation of North America, announced today that the U.S. Food and Drug Administration (FDA) has agreed to and approved the design of a single, pivotal, Phase III clinical trial evaluating farletuzumab (also known as MORAb-003) in platinum-sensitive ovarian cancer patients experiencing their first 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 III study 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 ovarian cancer at this stage, and we are hopeful that some day farletuzumab may provide an option for ovarian cancer patients and their caregivers."

Morphotek is currently concluding a Phase II trial with farletuzumab as a single-agent and in combination with standard-of-care chemotherapy (carboplatin and taxane) in platinum-sensitive ovarian cancer patients experiencing a first relapse of their disease. The trial was designed to measure objective rate of response, and to compare the length of a patient's second remission with her first remission. Interim results from the study demonstrated an encouraging rate of durable objective response in patients on combination therapy. These findings prompted pursuit of a definitive pivotal study to evaluate the capacity of farletuzumab to benefit patients with ovarian cancer in a rigorously controlled manner.

The Phase III study, the design of which was agreed to by FDA, will assess the capacity of farletuzumab to extend progression free survival and overall survival in combination with carboplatin and taxane at two different dose levels of farletuzumab. The study will be conducted as a randomized, double-blind, plac
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