Cell Genesys Advances GVAX(R) Lung Cancer Vaccine To Multicenter Phase I/II Trial
FOSTER CITY, Calif., Feb. 28 /PRNewswire/ -- Cell Genesys, Inc. today announced that it has initiated a multicenter Phase I/II clinical trial of GVAXÂ® lung cancer vaccine. This clinical trial follows an initial pilot study which demonstrated preliminary
``We are encouraged by the combination of safety and indications of antitumor activity we observed in our initial GVAXÂ® lung cancer vaccine trial, particularly in view of the fact that lung cancer has been largely unresponsive to other immunotherapies to date,'' stated Dale G. Ando, M.D., vice president, clinical research and regulatory affairs at Cell Genesys. ``GVAXÂ® cancer vaccines have now been reported to show evidence of immunologic and antitumor activity in all four types of cancer tested to date -- prostate cancer, lung cancer, melanoma and kidney cancer -- indicating that GVAXÂ® may be applicable to multiple types of cancer.''
The initial pilot study of GVAXÂ® lung cancer vaccine was conducted in patients with advanced lung cancer, the majority of whom had failed prior treatment with surgery, radiation and/or chemotherapy. Recently updated findings indicate that of the 22 patients evaluable, three patients had evidence of significant disease stabilization (in two cases continuing after 18 months), and one patient experienced a greater than 50 percent reduction in tumor size at two of three disease sites. In all cases, GVAXÂ® therapy was shown to be safe and well tolerated in the outpatient setting. In addition to the clinical evidence of antitumor activity described above, the vaccine has demonstrated potent antitumor immunity as evidenced by the microscopic examination of vaccination site and metastatic tumor site biopsies.
GVAXÂ® cancer vaccines are comprised of tumor cells which have been irradiated and genetically modified to secrete granulocyte-macrophage colony stimulating factor (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. The company's lead GVAXÂ® cancer vaccine program employs a non patient-specific form of the vaccine which will be commercialized as an off-the-shelf pharmaceutical. This GVAXÂ® configuration is currently being utilized in two multicenter Phase II trials in prostate cancer, and the company intends to apply this configuration to other cancers, including lung cancer. Cell Genesys is developing GVAXÂ® cancer vaccines for prostate cancer and lung cancer through a worldwide collaboration with the pharmaceutical division of Japan Tobacco Inc. (JT) which was signed in December 1998.
Cell Genesys' GVAXÂ® lung cancer vaccine is a patient-specific vaccine which is prepared at the hospital from tumor biopsy specimens in less than 24 hours. The gene modified tumor cells are irradiated for safety prior to patient administration. Cell Genesys believes that this patient-specific form of GVAXÂ® could be commercialized by selling a vaccine ``kit'' to hospitals where the vaccine would be prepared. Future development of GVAXÂ® lung cancer vaccine is expected to involve a non patient-specific form of the product similar to that now being evaluated for prostate cancer.
Cell Genesys is focused on the development and commercialization of gene therapies to treat cancer and other major, life-threatening diseases. The company is conducting two multicenter Phase II human clinical trials for its GVAXÂ® cancer vaccine in prostate cancer and a multicenter Phase I/II trial of GVAXÂ® vaccine in lung cancer. Preclinical stage programs include gene therapy for hemophilia, cancer, cardiovascular disorders and Parkinson's disease. Cell Genesys' assets outside gene therapy include its approximately 12 percent ownership of Abgenix, Inc. and the company's licensing program in gene activation technology. For additional information, please visit the company's web site at www.cellgenesys.com.
Clinical Trial Enrollment Information
Patients seeking information about how to participate in Cell Genesys' GVAXÂ® lung cancer vaccine trials can obtain information by visiting the company's web site at www.cellgenesys.com or by calling 650-425-4542.
Statements made herein, other than statements of historical fact, including statements about the progress and reports of results of GVAXÂ® clinical trials, the future of the collaboration with JT, including the timing and amount of payments to Cell Genesys, the company's progress and results of other clinical trials and preclinical programs, marketability of potential products and nature of product pipelines, licenses and intellectual property are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of research and development programs, the regulatory approval process, competitive technologies and products, patents, continuation of corporate partnerships with JT and other entities and additional financings. For information about these and other risks which may affect Cell Genesys, please see the company's Annual Report on Form 10-K dated March 31, 1999 as well as Cell Genesys' reports on Form 10-Q and 8-K and other reports filed from time to time with the Securities and Exchange Commission.
Jennifer Cook Williams