Positive, long-term, follow-up data reported from phase I trial of GVAX.

2003 OCT 1 - (NewsRx.com & NewsRx.net) -- Cell Genesys, Inc., (CEGE) reported long-term follow-up data from a phase I clinical trial of GVAX melanoma vaccine, a patient-specific vaccine made directly from patient tumor biopsies.

Data from this trial, which completed enrollment in mid-1999, involved patients with metastatic melanoma, the majority of whom had failed prior treatment including surgery, radiation, chemotherapy, and/or interferon. Of the 35 patients enrolled in this study, 10 patients (29%) remain alive with a minimum follow-up of 36 months, including four patients without evidence of recurrent disease following surgical resection of their tumor.

One complete response, one partial response, and one mixed response were observed following the initial treatment period, and the overall median survival was 15 months. Treatment with GVAX vaccine was safe and well tolerated in the outpatient setting, and vaccine was successfully manufactured in 97% of the enrolled patients. The study was conducted by Glenn Dranoff, MD, and colleagues at the Dana-Farber Cancer Institute, an affiliate of Harvard Medical School, and was reported in the September 1 issue of the Journal of Clinical Oncology.

"The trial reported corroborates a growing body of clinical data from multiple GVAX cancer vaccine trials which have demonstrated prolonged survival and increased time to disease progression in some patients and a side effect profile that compares favorably to standard cancer treatments. While we will continue to prioritize our more advanced clinical programs for GVAX prostate and lung cancer vaccines, the data for GVAX melanoma vaccine clearly indicate the potential broad applicability of this product platform," stated Joseph J. Vallner, PhD, president and chief operating officer of Cell Genesys.

"The melanoma trial also provides another example of the ability to successfully manufacture patient-specific GVAX products as we are currently doing in our lung cancer program. However, our focus will remain on GVAX products that can be developed as non patient-specific, off-the-shelf products," Vallner said.

In addition to the encouraging long-term follow-up data noted above, the phase I trial also demonstrated the ability of a GVAX cancer vaccine to elicit a specific immune response directed against the ...