Cell Genesys to Present Data From GVAX(R) Prostate Cancer and Myeloma Vaccine Clinical Trials at 2003 ASCO Annual Meeting
Wednesday April 2, 7:01 am ET
SOUTH SAN FRANCISCO, Calif., April 2 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE - News) today announced that both of its submitted abstracts have been accepted for presentation at the 2003 American Society of Clinical Oncology (ASCO) Annual Meeting which will take place in Chicago, IL, May 31 - June 3. The two abstracts to be presented by GVAX® cancer vaccine clinical investigators are as follows:
Abstract ID: 667: A Phase I/II Study of High Potency Allogeneic GM-CSF
Gene-Transduced Prostate Cancer Cell Line Vaccine in Patients with
Metastatic Hormone-Refractory Prostate Cancer (To be presented at Poster
Discussion by clinical investigator, Jonathan Simons, M.D., Director,
Winship Cancer Institute at Emory University School of Medicine - June 2,
2003, 8:00 a.m. - 12:00 p.m. CDT)
Abstract ID: 669: Autologous Tumor Combined with a GM-CSF-Secreting
Cell Line Vaccine Following Autologous Stem Cell Transplant (ASCT) in
Multiple Myeloma (To be presented at Poster Discussion by clinical
investigator, Ivan Borrello, M.D., Assistant Professor in Oncology,
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - June 2,
2003, 8:00 a.m. - 12:00 p.m. CDT)
"We are pleased that our clinical investigators will have this opportunity to present additional data from our GVAX® prostate cancer vaccine program as well as initial data from our myeloma program at the ASCO conference," stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "Data from the GVAX® cancer vaccine product portfolio continue to be promising, and we look forward to entering late-stage development beginning with the initiation of a Phase 3 clinical trial of GVAX® prostate cancer vaccine later this year."
The presentation at ASCO on the GVAX® prostate cancer vaccine program will provide data on the high-potency vaccine product which the company expects to advance into Phase 3 trials. The Phase 1/2 trial was designed as a dose-optimization study to facilitate Phase 3 trial design. In September 2002, the company updated long-term survival data from an earlier Phase 2 trial of GVAX® prostate cancer vaccine involving 34 patients with hormone-refractory prostate cancer metastatic to the bone. Five of 10 patients (50 percent) receiving the higher of two dose levels of the vaccine were reported to be alive 2.5 years after treatment (median survival = 31 months). Of the 24 patients receiving the lower dose of the vaccine, seven of 22 patients (32 percent) were reported to be alive 2.5 years after treatment (median survival = 22 months), and two were lost to follow-up. These results compare favorably to the reported median survival for hormone-refractory prostate cancer patients with bone metastases who are treated with chemotherapy, the current standard of care for this patient group.
Clinical trials of GVAX® cancer vaccines are under way for multiple types of cancer including prostate cancer, lung cancer, pancreatic cancer, leukemia and myeloma. Phase 3 trials of GVAX® prostate cancer vaccine and GVAX® lung cancer vaccine are expected to be initiated during the coming year. Cell Genesys' GVAX® cancer vaccines, which are designed to stimulate an immune response against the patient's tumor, are comprised of tumor cells that have been irradiated and genetically modified to secrete GM-CSF (granulocyte-macrophage colony stimulating factor), an immune stimulatory hormone which plays a key role in stimulating the body's immune response to vaccines.
Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is pursuing three cancer product platforms--GVAX® cancer vaccines, oncolytic virus therapies and cancer gene therapies. Clinical trials of GVAX® vaccines are under way in prostate cancer, lung cancer, pancreatic cancer, leukemia and myeloma. Clinical programs of oncolytic virus therapies include CG7870 for prostate cancer. Preclinical studies are in progress for additional GVAX® cancer vaccines, oncolytic virus therapies and cancer gene therapies for multiple types of cancer. Cell Genesys' majority-owned subsidiary, Ceregene, Inc., is focused on gene therapies for neurologic disorders. Cell Genesys also continues to hold approximately 8.7 million shares of common stock in its former subsidiary, Abgenix, Inc., an antibody products company. Cell Genesys is headquartered in South San Francisco, 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 the company and its subsidiaries, other than statements of historical fact, including statements about the company's progress, results and timing of clinical trials and preclinical programs and the 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 clinical trials and research and development programs, the regulatory approval process for clinical trials, competitive technologies and products, patents, continuation of corporate partnerships and the need for 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, 2003 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. The company assumes no obligation to update the forward-looking information in this press release.
Funding for the study described in this article was provided by Cell Genesys, Inc. Under a licensing agreement between Cell Genesys and the Johns Hopkins University, Dr. Borrello is entitled to a share of milestone payments and a share of royalty received by the University on sales of products described in this article. The terms of this arrangement are being managed by the Johns Hopkins University in accordance with its conflict of interest policies.
CONTACT: Jennifer Cook Williams, Director Corporate Communications and Investor Relations of Cell Genesys, Inc., +1-650-266-3200.
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Source: Cell Genesys, Inc. |
