Genitope Personalized Cancer Vaccine Gets FDA Fast Track Status
REDWOOD CITY, Calif. -- Genitope Corp. said Tuesday the Food and Drug Administration gave its cancer treatment candidate, MyVax, Fast Track status.
The move means the company can submit data from its Phase 3 clinical trial of the treatment as the study progresses, allowing for a faster review. Normally, a company would have to complete its Phase 3 clinical trial then submit the results.
The treatment, which focuses on non-hodgkins lymphoma, is a personal cancer vaccine. The treatment is also eligible for a priority review by the FDA, which has a timeline of six months.
Phase 2 studies of the drug showed 9 of 21 patients remained progression free 56 to 78 months after chemotherapy.
Shares of Genitope jumped on the news, gaining 48 cents, or 7.5 percent, in premarket electronic trading, from their Nasdaq close at $6.42.
REDWOOD CITY, Calif. -- Genitope Corp. said Tuesday the Food and Drug Administration gave its cancer treatment candidate, MyVax, Fast Track status.
The move means the company can submit data from its Phase 3 clinical trial of the treatment as the study progresses, allowing for a faster review. Normally, a company would have to complete its Phase 3 clinical trial then submit the results.
The treatment, which focuses on non-hodgkins lymphoma, is a personal cancer vaccine. The treatment is also eligible for a priority review by the FDA, which has a timeline of six months.
Phase 2 studies of the drug showed 9 of 21 patients remained progression free 56 to 78 months after chemotherapy.
Shares of Genitope jumped on the news, gaining 48 cents, or 7.5 percent, in premarket electronic trading, from their Nasdaq close at $6.42.
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