Cell Genesys Initiates Phase II Trial Of GVAX Vaccine.(Brief Article)

2001 NOV 14 - (NewsRx.com & NewsRx.net) -- Approximately 60 patients with pancreatic cancer will be enrolled in a new Phase II clinical trial of Cell Genesys Inc.'s GVAX vaccine. The study is being conducted at the Johns Hopkins Oncology Center and will include patients with pancreatic cancer who have undergone surgical resection of their tumor.

This trial was prompted by compelling results from an initial Phase I clinical trial of GVAX, which demonstrated antitumor immunity and prolonged, ongoing disease-free survival for as long as four years in a subset of patients. The new Phase II trial will evaluate the safety and efficacy of GVAX used in combination with surgical resection of pancreatic cancer followed by standard adjuvant radiation and chemotherapy.

The initial Phase I trial of GVAX pancreatic cancer vaccine was conducted in 14 patients who received the vaccine following surgical resection of their tumor along with standard adjuvant radiation and chemotherapy. It was reported in January 2001, in connection with a report on the trial in the Journal of Clinical Oncology, that three of eight patients who received the higher doses of the vaccine in combination with surgery and standard adjuvant therapy were alive and disease-free at 38, 35 and 33 months after diagnosis. Ten months later, these patients remain disease free at 48, 45 and 43 months after diagnosis. The three patients with prolonged disease-free survival also had biopsy-proven vaccine-induced antitumor immunity, a finding which was absent in the other five patients in the same treatment groups who had progressive pancreatic cancer. The significance of these findings was underscored by the fact that all three long-term survivors were judged to be at high risk for recurrent cancer due to microscopic evidence of pancreatic tumor following surgery or metastatic tumor in pancreatic lymph nodes. As with other GVAX clinical trials, vaccine treatment was safe and generally well-tolerated.

"We are encouraged by the initial results obtained with GVAX pancreatic cancer vaccine, particularly with ...