LINCOLNSHIRE, Ill. (AP) — BioSante Pharmaceuticals Inc. said Monday it hopes to restart testing of an experimental prostate cancer drug almost two years after the research was stopped.
BioSante said it will resume testing of its GVAX drug by year-end, subject to regulatory approval. The company that initially developed the vaccine, Cell Genesys, put a trial of the drug on hold in August 2008 because of a high number of deaths among patients taking the drug. Regulators then placed a halt on another study. BioSante bought Cell Genesys last October and is testing GVAX as a treatment for leukemia and pancreatic cancer.
The move comes only days after the Food and Drug Administration approved Dendreon Corp.’s prostate cancer drug Provenge. Both Provenge and GVAX are sometimes called vaccines because they are designed to train a patient’s immune system to fight cancer. However, they are therapies and not preventive treatments.
BioSante said it has started manufacturing new GVAX Prostate and is working to get the Food and Drug Administration to allow it to resume testing. It hopes to begin treating patients in a midstage clinical study in the beginning of the fourth quarter.
In morning trading, BioSante stock rose 14 cents, or 6 percent, to $2.49.
