company sponsoring the trial?
This was the CEGE GVAX trial:
Tuesday January 2, 7:30 am Eastern Time
Press Release
SOURCE: Cell Genesys, Inc.
Cell Genesys Updates Results From Initial Clinical Trial Of GVAX(R) Pancreatic Cancer Vaccine
Positive Clinical Data Prompt Plans for Phase II Study in 2001
FOSTER CITY, Calif., Jan. 2 /PRNewswire/ -- Cell Genesys, Inc. (Nasdaq: CEGE - news) today reported an encouraging update to the preliminary clinical data which were announced in May from an initial trial of GVAX® pancreatic cancer vaccine conducted by Johns Hopkins Oncology Center. Three of eight patients who received the higher doses of the vaccine in combination with surgery and standard adjuvant therapy and who were previously reported to be disease-free for more than two years, remain alive and disease-free at 38, 35 and 33 months after diagnosis. The results of the Phase I trial were published in a January issue of the Journal of Clinical Oncology by Elizabeth M. Jaffee, M.D. and colleagues at Johns Hopkins School of Medicine. Based on these results, a Phase II clinical trial of GVAX® pancreatic cancer vaccine in approximately 60 patients is planned to begin during 2001.
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. The three patients with prolonged disease-free survival also have biopsy-proven vaccine-induced antitumor immunity, a finding which was absent in the other 11 patients, who relapsed. 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.
``Although this initial study was not designed to evaluate efficacy, we are very pleased that the three GVAX® responders from our clinical trial continue to remain disease-free approximately three years after diagnosis, especially given that the median time to progression in this group of pancreatic cancer patients is approximately 1 year,'' stated Dr. Jaffee, associate professor of oncology and immunology at Johns Hopkins University School of Medicine. ``Although these results must be regarded as preliminary given the small number of patients, we believe our findings strongly support advancing this vaccine strategy into Phase II trials.''
The GVAX® vaccine evaluated in this Phase I trial was comprised of allogeneic (non patient-specific) pancreatic cancer cells genetically modified to secrete granulocyte-macrophage colony stimulating factor (GM-CSF), an immune stimulatory hormone, and then irradiated for safety. The vaccine was administered before and after the post-operative radiation and chemotherapy as an intradermal (under the skin) injection. Up to four vaccine treatments were administered. Patients were then monitored for treatment effect using standard clinical and radiologic tests.
GVAX® cancer vaccines are comprised of tumor cells which have been irradiated and genetically modified to secrete GM-CSF, a hormone which plays a key role in stimulating the body's immune response to vaccines. The genetically modified tumor cells are used to vaccinate patients to stimulate an immune response against their tumor. GVAX® cancer vaccines have demonstrated antitumor effects in each of the human clinical trials they have been tested in to date -- prostate cancer, pancreatic cancer, lung cancer, renal cancer and melanoma. The company's GVAX® cancer vaccine program emphasizes a non patient-specific form of the vaccine which could be commercialized as an off-the-shelf pharmaceutical. As noted above, a non patient-specific format is being evaluated in the clinical trials in pancreatic cancer.
Peter |
