Genitope Corporation to Suspend Development of MyVax(R) Personalized Immunotherapy
Monday March 10, 9:06 pm ET
FREMONT, Calif.--(BUSINESS WIRE)--Genitope Corporation (NASDAQ:GTOP - News) today announced that, based on a meeting with representatives of the U.S. Food and Drug Administration (FDA) to discuss the previously announced results of Genitope’s pivotal Phase 3 clinical trial of MyVax® personalized immunotherapy in previously untreated follicular B-cell non-Hodgkin’s lymphoma (fNHL) patients, Genitope intends to suspend development of MyVax® personalized immunotherapy. Genitope is evaluating its alternatives with respect to the other aspects of its business, including development of its monoclonal antibody program.
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Genitope previously announced that its Phase 3 clinical trial of MyVax® personalized immunotherapy did not meet its primary endpoint. In the primary analysis, there was no statistically significant difference in the progression-free survival (PFS) of patients receiving MyVax® personalized immunotherapy compared to patients receiving the control substance. However, analysis of a pre-specified endpoint in the MyVax® personalized immunotherapy arm 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.
After a review of the data, the FDA has communicated to Genitope 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® personalized immunotherapy would be required before the FDA would accept a Biologics License Application for FDA review. Genitope has determined that it is not feasible at this time to pursue further clinical trials of MyVax® personalized immunotherapy prior to receipt of FDA approval. Genitope is evaluating its alternatives with respect to the MyVax® personalized immunotherapy program.
“We are disappointed that we will not be able to make MyVax® personalized immunotherapy available to patients with follicular non-Hodgkin’s lymphoma,” said Dan W. Denney, Jr., Ph.D., chairman and chief executive officer of Genitope Corporation. “We firmly believe that MyVax® personalized immunotherapy has the potential to safely induce long-term remissions, possibly including life-long remissions. We greatly appreciate the support for MyVax® personalized immunotherapy that we have received from patients, clinicians, our employees and our stockholders. However, we recognize that the costs and time required for further clinical development of MyVax® personalized immunotherapy are prohibitive at this time, and we thus intend to focus our efforts on the development of our monoclonal antibody program.”
Genitope Corporation is evaluating its financial position and plans for continued operations and intends to provide additional information when available. |
