Cell Genesys reports encouraging long-term survival data in phase II trial.(Brief Article)

2002 JUN 19 - (NewsRx.com & NewsRx.net) -- Cell Genesys, Inc. (CEGE) reported encouraging long-term survival data from a phase II multicenter clinical trial of GVAX prostate cancer vaccine, which demonstrates a dose-dependent trend toward prolonged survival in patients with hormone refractory prostate cancer metastatic to bone.

In the 34-patient study, 7 of 10 (70%) patients receiving the higher dose level of the vaccine are alive 2.5 years after treatment (median survival greater than 30 months). Of the 24 patients receiving the lower dose of the vaccine, nine of 22 patients (41%) are alive 2.5 years after treatment (median survival 22 months), and two were lost to follow-up. These results compare favorably to the reported median survival of seven to 11 months for hormone refractory prostate cancer patients with bone metastases who are treated with chemotherapy, the current standard of care for this patient group. The dose-dependent improvement in survival was consistent with a previously reported improvement in time to disease progression measured by both radiologic and prostate-specific antigen (PSA) endpoints also in favor of the high dose group. Treatment with GVAX vaccine was safe and well tolerated. These data were presented at the American Society of Clinical Oncology (ASCO) meeting in Orlando, Florida, by Jonathan Simons, MD, of Emory University.

The study reported at ASCO employed a 6-month treatment regimen in which patients received an initial "priming" dose of GVAX prostate cancer vaccine followed by 12 biweekly "booster" doses using either a high dose or threefold lower dose regimen. The two dose groups were comparable with respect to disease stage, duration and prior treatment for their prostate cancer as well as other demographic criteria. The vaccine, which is a non patient-specific, "off-the-shelf" product was administered by an intradermal injection ...