Cell Genesys' GVAX trial gets IDMC go ahead
USA-based biotechnology firm Cell Genesys says that, following the successful completion of an independent data monitoring board review, it is to continue with a Phase III study of its immunotheapy product GVAX. The drug, which is being assessed as a treatment for prostate cancer, is composed of non-patient specific cells that produce granulocyte-macrophage colony stimulating factor (GMC-SF), a hormone that up-regulates the production of white blood cells.
The trial in question, VITAL-1, is designed to compare the therapeutic efficacy of GVAX with Sanofi-Aventis' Taxotere (docetaxel) plus prednisone in men suffering from metastatic hormone-refractory forms of the disease. A second ongoing study, VITAL-2, is evaluating the safety and efficacy of a combination of GVAX and Taxotere in such patients.
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