Genitope Corporation said, based on a meeting with representatives of the US Food and Drug Administration (FDA) to discuss the previously announced results of Genitope's pivotal phase III clinical trial of MyVax personalised immunotherapy in previously untreated follicular B-cell non-Hodgkin's lymphoma (fNHL) patients, Genitope intends to suspend development of MyVax personalised immunotherapy.
Genitope is evaluating its alternatives with respect to the other aspects of its business, including development of its monoclonal antibody programme.
Genitope previously announced that its phase III clinical trial of MyVax personalised 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 personalised immunotherapy compared to patients receiving the control substance. However, analysis of a pre-specified endpoint in the MyVax personalised immunotherapy arm showed a highly statistically significant difference in PFS between patients who mounted a positive immune response to the tumour-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 III clinical trial's failure to meet its primary endpoint, one or more additional Phase III clinical trials for MyVax personalised 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 personalised immunotherapy prior to receipt of FDA approval. Genitope is evaluating its alternatives with respect to the MyVax personalised immunotherapy programme.
"We are disappointed that we will not be able to make MyVax personalised immunotherapy available to patients with follicular non-Hodgkin's lymphoma," said Dan W. Denney, Jr., Ph.D., chairman and chief executive officer, Genitope Corporation. "We firmly believe that MyVax personalised immunotherapy has the potential to safely induce long-term remissions, possibly including life-long remissions. We greatly appreciate the support for MyVax personalised 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 personalised immunotherapy is prohibitive at this time, and we thus intend to focus our efforts on the development of our monoclonal antibody programme."
Genitope Corporation is evaluating its financial position and plans for continued operations and intends to provide additional information when available.