Cell Genesys Secures Memphis Facility for Manufacturing of Patient-Specific Lung Cancer Vaccines
FOSTER CITY, Calif., Feb. 12 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE - news) today announced that the company has leased a 35,000 square-foot facility in Memphis, TN which it plans to use to manufacture the company's patient-specific GVAX® lung cancer vaccines for both Phase III clinical trials and potential market launch. Memphis, one of the major shipping hubs in the world, was chosen to facilitate the efficient transport and distribution of patient vaccines to treatment centers across the United States. The facility sets the stage for Cell Genesys' product development strategy for GVAX® lung cancer vaccines which includes establishing a centrally located GMP (Good Manufacturing Practices) facility to receive and process frozen tumor cells obtained from patient biopsies, manufacture the patient-specific vaccine products and carry out quality control testing, and ship the frozen vaccine products back to the patient treatment centers.
Cell Genesys expects the new Memphis facility to be operational in time for the initiation of Phase III trials of GVAX® lung cancer vaccine expected to begin in late 2002. A Director of Memphis Operations has been hired, and the company is beginning facility modifications in order to have validated GMP manufacturing capabilities in place prior to the initiation of these Phase III trials. The cost of these improvements as well as the initial operating costs for the Memphis operation have been included in the company's previously forecasted expenditures for 2002. This new Memphis facility is an important complement to Cell Genesys' two other manufacturing facilities, which include a 41,000 square-foot facility currently under construction in Hayward, CA for cell-based products and an existing 48,000 square-foot facility in San Diego, CA for viral-based products. The company expects to manufacture non patient-specific GVAX® cancer vaccine products in Hayward and oncolytic virus and viral gene therapy products in San Diego.
``Our new Memphis facility is the remaining component of the manufacturing infrastructure we need to implement our plans for multiple Phase III trials and future potential product launches. The Memphis site will enable the rapid production and shipping of patient-specific vaccines such as GVAX® lung cancer vaccine and will complement the centralized production of non patient-specific, 'off-the-shelf' products such as GVAX® prostate and pancreatic cancer vaccines which will be carried out in our Hayward facility,'' stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. ``Memphis is an ideal site for this type of manufacturing operation given its well established infrastructure for overnight air shipment, as well as an attractive real estate market and a world renowned biomedical community.''
GVAX® lung cancer vaccine is a patient-specific vaccine derived from the patient's own tumor which is obtained by surgical biopsy. In Cell Genesys' initial Phase II GVAX® lung cancer vaccine trial, the patient's own tumor cells were directly modified to produce an immune hormone called granulocyte-macrophage colony stimulating factor (GM-CSF) which stimulates an antitumor immune response directed against the patient's tumor. In late 2001, Cell Genesys reported updated results from this trial which demonstrated a complete tumor response rate of 12 percent and a median response duration of at least 11 months in 26 patients with advanced non small-cell lung cancer who have failed chemotherapy and/or radiation therapy. In addition to the responses in patients with advanced disease, eight of the ten patients with early-stage lung cancer who received GVAX® lung cancer vaccine following surgery, currently remain free of disease with a median follow-up time of 12 months.
Cell Genesys is currently conducting clinical trials of GVAX® cancer vaccines in five types of cancer including lung, prostate, pancreatic, leukemia and multiple myeloma. The company is currently testing both patient-specific and non patient-specific GVAX® vaccines since it believes that different types of cancer may benefit from treatment with one or the other type of vaccine. Non patient-specific vaccines, which can be developed as ``off-the-shelf'' pharmaceuticals, are currently being tested in patients with prostate and pancreatic cancer, whereas patient-specific vaccines are being tested in patients with lung cancer, myeloma and leukemia. GVAX® cancer vaccines have demonstrated antitumor activity in all human clinical trials reported to date and have been safely administered to well over 350 patients with a very favorable side effect profile compared to other cancer treatments.
Cell Genesys is focused on the development and commercialization of innovative therapeutic products for cancer based on gene therapy technologies. The company is pursuing three cancer product platforms -- GVAX® cancer vaccines, oncolytic virus therapies and in vivo cancer gene therapies. Clinical trials of GVAX® vaccines are under way in prostate cancer, lung cancer, pancreatic cancer, leukemia and myeloma. Clinical trials of oncolytic virus therapies include CG7060 and CG7870 in prostate cancer. Preclinical stage programs include oncolytic virus therapies and gene therapies for multiple types of cancer. Cell Genesys' majority-owned subsidiary, Ceregene, is focused on gene therapies for neurologic disorders. Cell Genesys also continues to hold approximately nine million shares of common stock in its former subsidiary, Abgenix, an antibody products company. Cell Genesys is headquartered in Foster City, CA and has manufacturing operations in San Diego, CA, Hayward, CA and Memphis, TN. For additional information, please visit the company's website at www.cellgenesys.com.
Statements made herein about Cell Genesys and its subsidiaries, other than statements of historical fact, including statements about the progress, reports and timelines of clinical trials, including those evaluating GVAX® cancer vaccines, the ability to manufacture GVAX® cancer vaccines, the ability to validate and staff manufacturing facilities and nature of product pipelines 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 ability to manufacture products for clinical trials, the ability to staff a new facility, the success and results of clinical trials and preclinical studies, the regulatory approval process, competitive technologies and products, patents, additional financings and the continuation of collaborations including the collaboration with JT. For information about these and other risks which may affect Cell Genesys, please see the company's Annual Report on Form 10-K dated April 2, 2001 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, Associate Director of Corporate Communications of Cell Genesys, Inc., +1-650-425-4542.
SOURCE: Cell Genesys, Inc. |
