Apr
Genitope Corporation (Genitope, NASDAQ: GTOP) announced that a summary of the data from its pivotal Phase 3 clinical trial examining the use of MyVax® personalized immunotherapy (MyVax) in previously untreated follicular B-cell non-Hodgkin’s lymphoma (fNHL) patients is available on the Investor Relations section of Genitope’s Web site at http://ir.genitope.com. In December 2007, Genitope obtained data indicating that its pivotal Phase 3 clinical trial did not meet its primary endpoint. The primary analysis demonstrated that there was no statistically significant difference in the progression-free survival (PFS) of patients receiving MyVax compared to patients receiving a non-specific control immunotherapy. However, analysis of a pre-specified endpoint in the group of patients receiving MyVax showed a highly statistically significant difference in PFS between patients who mounted a positive immune response to the tumor-specific target and those who did not.
In early March 2008, Genitope met with the U.S. Food and Drug Administration (FDA) to discuss a potential regulatory path forward for MyVax. The FDA communicated to Genitope during this meeting that, in light of the Phase 3 clinical trial’s failure to meet its primary endpoint, one or more additional Phase 3 clinical trials for MyVax would be required before the FDA would accept a Biologics License Application for FDA review. In light of the FDA’s decision, Genitope suspended the development of MyVax in March 2008.
“We are extremely disappointed in the FDA’s decision and deeply saddened that Genitope is unlikely to be able to make MyVax personalized immunotherapy available to fNHL patients in the U.S.,” said Dan W. Denney, Jr., Ph.D., chairman and chief executive officer of Genitope Corporation.
Dr. Ronald Levy, Professor of Medicine, Stanford University Medical Center, is scheduled to present data from Genitope’s pivotal Phase 3 clinical trial of MyVax at the annual American Association for Cancer Research meeting taking place in San Diego, CA from April 12 - 16, 2008. The presentation will be held on Monday, April 14 at 4:30pm at Hall G-H at the San Diego Convention Center.
About Genitope Corporation
Genitope Corporation (Fremont, Calif.) is a biotechnology company focused on the research and development of novel immunotherapies for the treatment of cancer. Until Genitope recently suspended its development, its lead product candidate was MyVax personalized immunotherapy, a patient-specific active immunotherapy that is based on the unique genetic makeup of a patient’s tumor and is designed to activate the patient’s immune system to identify and attack cancer cells. Genitope is also developing a monoclonal antibody panel that it believes will potentially represent a novel, personalized approach for treating NHL.
http://www.genitope.com