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BioSante's investigational pancreatic cancer vaccine granted orphan drug status
Monday, March 15 2010 | Comments
What's This?
The Food and Drug Administration granted an orphan drug designation to BioSante Pharmaceuticals Inc.'s GVAX pancreas vaccine for the treatment of patients with pancreatic cancer.The specialty pharmaceutical company gained access to the vaccine, which is part of a larger GVAX cancer immunotherapy program, through its merger with Cell Genesys Inc. last year. GVAX cancer immunotherapies are treatments consisting of whole tumor cells that have been modified to secrete granulocyte macrophage colony-stimulating factor and then irradiated for safety. The treatments are administered via intradermal injections on an outpatient basis.
Clinical trials of the GVAX pancreas vaccine are ongoing and will be used to determine the safety, overall survival and treatment response associated with the vaccine. Researchers are comparing regimens that consist of the vaccine plus other cancer agents versus the other cancer agents alone or in combination with therapies other than the vaccine.
BioSante is also conducting trials of GVAX vaccines for the treatment of various other cancers, including leukemia and breast cancer.
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