FDA lifts clinical hold on BioSante prostate cancer vaccine ...

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The FDA?s clinical hold on BioSante Pharmaceuticals? (NASDAQ:BPAX) GVAX prostate cancer vaccine?for the treatment of prostate cancer has been lifted by FDA. BioSante said manufacturing of new vaccine is complete, and planning for a Phase 2 clinical trial at the Johns Hopkins Kimmel Cancer Center is underway.

BioSante funded the manufacturing of the vaccine and the trial will be supported in part by the Prostate Cancer Foundation, with start-up funding provided by the OneInSix Foundation.

?A joint effort among the various parties involved has resulted in the FDA lifting the GVAX Prostate clinical hold, which is a positive step for development of a new prostate cancer vaccine and the men who may benefit,? BioSante CEO Stephen Simes said in a statement.

?Now that the FDA has approved the first-ever therapeutic cancer vaccine, Provenge, for the treatment of prostate cancer, we have renewed confidence that GVAX Prostate can be a valuable addition to prostate cancer patient care,? he added.?

Provenge requires isolation of cells from the patient that are then modified to produce the vaccine which is then re-introduced into the patient. GVAX Prostate is a non-patient-specific vaccine comprised of prostate cancer cells that have been modified to secrete granulocyte-macrophage colony-stimulating factor, an immune stimulatory cytokine, and then irradiated for safety.

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Related posts:

1. BioSante vaccine survival data published
2. BioSante melanoma vaccine gets orphan drug nod
3. OncoGenex starts prostate cancer trial

Source: http://biotuesdays.com/2011/06/06/fda-lifts-clinical-hold-on-biosante-prostate-cancer-vaccine/

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