>>SOUTH SAN FRANCISCO, Calif., Aug. 19 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE - News) today announced the publication of encouraging immunologic data for GVAX® pancreatic cancer vaccine, a non patient-specific vaccine which is being developed as an "off-the-shelf" pharmaceutical product. In a previously reported Phase 1 trial of this product, 14 patients received the vaccine after pancreatic cancer surgery and standard adjuvant therapy. Three patients remain alive and disease-free at their most recent follow-up of at least 6.5 years.
The newly published article describes a detailed analysis of the immune response to the vaccine product in these patients. Of particular note is that all three long-term survivors demonstrated strong T cell responses to mesothelin, a tumor-associated molecule found on GVAX® pancreatic cancer vaccine cells, and that the specificity of the T cell response to mesothelin was unique to each responding patient. In contrast, only one of the 11 patients who progressed and died from pancreatic cancer mounted a detectable immune response to mesothelin and the level of response in this patient was minimal by comparison. These findings provide evidence that patient-specific immune responses can be generated following vaccination with a non patient-specific GVAX® cancer vaccine product and that such responses may correlate with clinical outcome. The results were published in an August issue of the Journal of Experimental Medicine by Elizabeth Jaffee, M.D., professor of Oncology, and colleagues at the Johns Hopkins Kimmel Cancer Center.
"These newly published results provide compelling evidence in humans that a non patient-specific GVAX® vaccine product can be used to generate antitumor immunity, with a profile specific to each vaccinated patient," said Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "Such findings are important because they provide further scientific proof-of-concept for our GVAX cancer vaccine strategy, which is focused on non patient-specific, "off-the-shelf" products. For example, our GVAX® prostate cancer vaccine, which is currently in Phase 3 clinical trials, is a non patient-specific vaccine product."
The initial Phase 1 trial of GVAX® pancreatic cancer vaccine was conducted at the Johns Hopkins Kimmel Cancer Center in 14 patients who received the vaccine following surgical resection of their tumor and standard adjuvant radiation and chemotherapy. As first reported in the Journal of Clinical Oncology in January 2001, three of eight patients who received the higher dose levels of the vaccine had prolonged disease-free survival and this continues to be true at their most recent follow-up of at least 6.5 years. This outcome is considered particularly significant since all three long-term survivors were judged to be at high risk for recurrent cancer due to microscopic evidence of pancreatic tumor following surgery and/or metastatic tumor in pancreatic lymph nodes. In addition, the three patients with prolonged disease-free survival had biopsy-proven vaccine-induced antitumor immunity as well as delayed type sensitivity (DTH) reactions against their own tumor cells, findings not seen in the patients whose cancer progressed. This observed relationship between evidence of an immune response to the vaccine and clinical outcome is further supported by T cell responses to mesothelin described in the Journal of Experimental Medicine article. As with other GVAX® clinical trials, vaccine treatment was generally well tolerated.
A follow-on Phase 2 clinical trial of GVAX® pancreatic cancer vaccine in patients with operable pancreatic cancer who receive the vaccine after surgical resection of tumor and adjuvant radiation chemotherapy is currently being conducted at the Johns Hopkins Kimmel Cancer Center. To date, the study has enrolled approximately 50 out of a projected 60 patients. Enrollment is expected to be completed this year, in which case preliminary data may be available during 2005.<<
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