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Morphotek(R), Inc. and Eisai Corporation of North America Announce FDA Special Protocol Assessment (SPA) for Phase III Trial Evaluating Farletuzumab in Relapsed Ovarian Cancer
Date:3/23/2009

ebo-controlled trial. Morphotek expects to enroll up to 900 subjects in this clinical study that will be conducted globally at sites in North America, South America, Europe, Australia and Asia.

"Ovarian cancer is a disease that is devastating to the lives of patients and caregivers," said Nicholas Nicolaides, Ph.D., President and Chief Executive Officer at Morphotek. "The agreement reached in the SPA process for farletuzumab's Phase III trial may bring us one step closer to providing hope in their lives and further exemplifies our human health care (hhc) mission to bring treatments to the people who need them most."

Farletuzumab is a monoclonal antibody that binds to and blocks the function of folate receptor alpha (FRA), a cell surface protein on tumor cells that confers a growth advantage to tumorigenic cells in vitro. FRA has been demonstrated by several independent studies to be expressed on ovarian cancer cells. Preclinical data support the theory that farletuzumab achieves its pharmacological effect by two mechanisms: first, by the capacity of farletuzumab to block signaling inside cancer cells and, second, by stimulating the patient's immune system to attack and destroy the FRA positive-tumor cells. The pre-cursor to farletuzumab was originally developed by Dr. Lloyd Old at the Ludwig Institute for Cancer Research applying his pioneering work that employed whole cell immunization of tumors to identify cell surface factors. These efforts led to the development of a panel of novel antibodies that can recognize tumor cell surface antigens as well as tumor stromal cell surface antigens. Morphotek licensed the antibody and improved it using 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 Cancer Institute estimates that there were 21,650 new cases of ovarian
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SOURCE Morphotek, Inc.
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