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news.Following encouraging results from previous investigations of its Gvax vaccine in prostate cancer, Cell Genesys has initiated a second phase III clinical trial to compare the drug, in combination with Sanofi-Aventis' Taxotere, to the current standard of care.
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The study will compare the survival benefits of using Gvax vaccine for prostate cancer plus Taxotere (docetaxel) chemotherapy to Taxotere plus prednisone in patients with metastatic hormone-refractory prostate cancer.
Researchers expect to enroll approximately 600 patients at around 100 medical centers across the US and Europe. Cell Genesys has already received confirmation from the FDA that the trial design would adequately support a product registration application.
Cell Genesys is conducting two phase III clinical trials of Gvax vaccine for prostate cancer in hormone-refractory prostate cancer patients with radiologic evidence of metastatic disease. Clinical trials of Gvax cancer vaccines are also under way for multiple types of cancer in addition to prostate cancer, including leukemia and pancreatic cancer.
Previously reported findings from the company’s first phase II trial of GVAX vaccine for prostate cancer indicated an overall median survival of 26.2 months. The median survival results from both phase II trials compare favorably to the recently reported median survival of 18.9 months for hormone-refractory metastatic prostate cancer patients treated with Taxotere plus prednisone, the current standard of care.