Firm’s inability to comply with FDA’s call for additional Phase III studies sealed the decision.
Genitope has decided to suspend development of MyVax. The company’s value took a 210% plunge from $0.59 at close yesterday to $0.19 at the open of trading today.
Genitope’s stock initially suffered back in December 2007, when the company reported the failure of its Phase III trial with MyVax personalized immunotherapy for previously untreated follicular B-cell non-Hodgkin’s lymphoma (fNHL). At the time, the company lost about 63% of it’s value in the first day of trading after Genitope reported Phase III data.
The decision to ax development of MyVax came after a meeting with the FDA to discuss the results from the Phase III trial. The agency found that in light of the Phase III study’s failure to meet its primary endpoint, one or more additional late-stage evaluation for MyVax would be required for the agency to accept the BLA for review.
Genitope has determined that it is not feasible at this time to pursue further clinical trials of MyVax prior to receipt of FDA approval. The firm reports that it is currently evaluating alternatives for the MyVax program.
In the primary analysis of the Phase III trial data, there wasn’t any statistically significant difference in progression-free survival (PFS) of patients receiving MyVax compared to the control substance. Analysis of a prespecified endpoint in the MyVax arm, however, 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, according to the company.
