Genitope suspends personalised drug development

US biotech company Genitope Corporation is set to suspend development of its MyVax personalised immunotherapy.

The plans follows discussions with US Food and Drug Administration (FDA) representatives on the Phase 3 clinical trial of MyVax in previously untreated follicular B-cell non-Hodgkin's lymphoma (fNHL) patients.

Genitope previously announced that its Phase 3 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 tumor-specific target and those who did not.

After a review of the data, the FDA told 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 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, chairman and chief executive officer of 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 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.

The company, which is focused on the research and development of novel immunotherapies for the treatment of cancer, is also developing a monoclonal antibody panel that it believes will potentially represent a novel, personalised approach for treating NHL.