High-Potency Vaccine Enter Trials In Those Who Failed Hormone Therapy.(Brief Article)

2001 MAY 9 - (NewsRx.com & NewsRx.net) --

Cell Genesys, Inc. (CEGE) announced April 17, 2001, that it has initiated the first in a series of clinical trials of a high potency version of GVAX(R) prostate cancer vaccine following encouraging Phase II clinical data recently reported for its first generation product.

The testing of this new high potency product will explore various treatment regimens and will be conducted in prostate cancer patients who have failed standard hormone therapy.

The series of trials is anticipated to involve a total of approximately 40 to 60 patients depending upon the number of treatment regimens tested and will include an evaluation of GVAX prostate cancer vaccine in combination with chemotherapy. These trials will be conducted at multiple centers in the United States and are designed to provide clinical data to support the initiation of a Phase III trial, which is targeted for late 2002.

The new high potency form of GVAX prostate cancer vaccine is similar to the first generation product except that it releases an increased quantity of immune system stimulant that enhances antitumor immunity. The recently initiated clinical trials of the high potency GVAX prostate cancer vaccine are designed to evaluate the safety and efficacy of the new product and further optimize the treatment regimen for advanced clinical testing. The efficacy endpoints in these studies will include time to disease progression as measured by bone scan and overall survival.

As was true for the first generation product, which the new form should replace, the high potency GVAX prostate cancer vaccine is a non patient-specific product that will be manufactured ...