Tuesday September 12, 7:30 am Eastern Time
Press Release
SOURCE: Cell Genesys, Inc.
Cell Genesys Reports Further Encouraging Results From Initial Phase I/II Trial Of GVAX(R) Lung Cancer Vaccine
Vaccine Demonstrates Enhanced Antitumor Immunity
FOSTER CITY, Calif., Sept. 12 /PRNewswire/ -- Cell Genesys, Inc. (Nasdaq: CEGE - news) today announced an encouraging follow-up report on an initial clinical trial of GVAX® lung cancer vaccine. The trial was conducted in patients with advanced non small-cell lung cancer, the majority of whom have failed prior treatment with surgery, radiation and/or chemotherapy. Eighteen of 25 patients who received the complete course of vaccinations demonstrated enhanced antitumor immunity as measured by delayed-type hypersensitivity (DTH) skin reactions. In addition, two patients continue to experience disease-free survival for more than two years after treatment and three other patients were reported to have stable disease without evidence of tumor progression after 15, eight and four months respectively. Treatment with GVAX® vaccine was safe and well tolerated in the outpatient setting. These data were presented by Ravi Salgia, M.D., Ph.D. and colleagues of Dana-Farber/Partners Cancer Care at the Ninth World Conference on Lung Cancer in Tokyo, Japan.
This initial clinical trial of GVAX® vaccine in lung cancer is testing a patient-specific product format in which the vaccine is prepared from the patient's own tumor cells in an overnight process carried out at the hospital where the patient is treated. The feasibility of this approach was demonstrated by the successful preparation of vaccine product for over 90 percent of the patients enrolled in the study. Based on the results of the initial trial, Cell Genesys initiated a multicenter Phase I/II clinical trial of GVAX® lung cancer vaccine in approximately 40 patients with both early stage and advanced non small-cell lung cancer. More than 35 patients have already been enrolled in this trial since it began earlier this year. In addition, Cell Genesys plans to develop a non patient-specific GVAX product for lung cancer since other non patient-specific GVAX® vaccines have previously been reported to demonstrate encouraging results in initial clinical trials in prostate cancer and pancreatic cancer.
``We are encouraged by the longer term follow-up report on this initial GVAX® lung cancer vaccine trial, particularly since lung cancer has been largely unresponsive to other immunotherapies to date,'' stated Joseph J. Vallner Ph.D., executive vice president and chief operating officer at Cell Genesys. ``GVAX® cancer vaccines have now demonstrated antitumor activity in all five cancers tested to date including prostate cancer, lung cancer, pancreatic cancer, kidney cancer and melanoma.''
GVAX® cancer vaccines are comprised of tumor cells which have been 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 then irradiated for safety and used to vaccinate patients to stimulate an immune response against their tumor. The company's lead GVAX® cancer vaccine program targets patients with recurrent prostate cancer and is currently being evaluated in two multicenter Phase II trials. Additionally, a Phase II trial of GVAX® pancreatic cancer vaccine and Phase I trials of GVAX® vaccine for myeloma and leukemia are expected to commence by early 2001. In addition to clinical trial progress, Cell Genesys is also developing large scale manufacturing capabilities as well as higher potency GVAX® products for prostate and other cancers that could allow for more efficient vaccine administration. GVAX® cancer vaccines for prostate cancer and lung cancer are being developed by Cell Genesys through a worldwide 50:50 profit sharing agreement with the pharmaceutical division of Japan Tobacco Inc. (JT). The company retains North American marketing rights for prostate and lung cancer and worldwide rights to all other cancers including pancreatic cancer, myeloma and leukemia.
At the American Society of Clinical Oncology Meeting in May, Cell Genesys announced encouraging data from a Phase I trial of GVAX® pancreatic cancer vaccine and a preclinical study of GVAX® vaccine for leukemia. In a human clinical trial in fourteen pancreatic cancer patients conducted at the Johns Hopkins Oncology Center, three of eight patients receiving the two highest doses of the vaccine are alive and free of disease more than two years later while all six patients receiving the two lowest doses have relapsed. These patients received the vaccine following surgery and adjuvant radiation and chemotherapy. In addition, as reported in a May issue of the journal, Blood, studies of GVAX® vaccine in a mouse model of acute leukemia conducted at Johns Hopkins University, significantly prevented tumor relapse when administered following bone marrow transplantation.
Cell Genesys is focused on the development and commercialization of cancer vaccines and gene therapies to treat major, life-threatening diseases. The company is conducting two multicenter Phase II human clinical trials for its GVAX® cancer vaccine in prostate cancer, a multicenter Phase I/II trial of GVAX® vaccine in lung cancer and expects to initiate additional GVAX® vaccine trials in pancreatic cancer, myeloma and leukemia during the coming year. 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.
Statements made herein, other than statements of historical fact, including statements about the progress and reports of results of GVAX® 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, successful development of large scale manufacturing capabilities, marketability and success 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 success and results of clinical trials, 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 30, 2000 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.
CONTACT: Jennifer Cook Williams, Manager, Corporate Communications of Cell Genesys, Inc., 650-425-4542.
SOURCE: Cell Genesys, Inc. |
