Prostate Cancer Vaccine gets Special Protocol Assessment by FDA
May 19, 2005 - 9:35:00 AM, Reviewed by: Dr.
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"The SPAs for our two Phase 3 trials provide Cell Genesys with a well-defined pathway for regulatory submission for our lead product candidate, GVAX(R) vaccine for prostate cancer."
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By Cell Genesys,
Cell Genesys, Inc. today announced that it has received a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) for its second Phase 3 clinical trial of GVAX(R) vaccine for prostate cancer. The SPA is a process that allows for official FDA evaluation of a Phase 3 clinical trial and provides trial sponsors with binding written agreement that the design and analysis of the study are adequate to support a license application submission if the study is performed according to the SPA.
The company's first Phase 3 trial of GVAX(R) vaccine for prostate cancer was initiated in July 2004 and was also granted a SPA by the FDA.
"The SPAs for our two Phase 3 trials provide Cell Genesys with a well-defined pathway for regulatory submission for our lead product candidate, GVAX(R) vaccine for prostate cancer," stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "We look forward to initiating the second Phase 3 clinical trial of this GVAX(R) vaccine and hope that this product may one day benefit patients with prostate cancer."
Cell Genesys is currently planning two Phase 3 clinical trials of GVAX(R) vaccine for prostate cancer in hormone-refractory prostate cancer patients with radiologic evidence of metastatic disease. The first trial (VITAL-1 or Vaccine ImmunoTherapy with Allogeneic prostate cancer cell Lines) was initiated in July 2004 and is enrolling chemotherapy naive, asymptomatic patients without cancer-related pain and is comparing GVAX(R) vaccine to Taxotere(R) (docetaxel) chemotherapy plus prednisone with respect to a survival benefit. The trial is expected to enroll 600 patients and is designed to demonstrate a 33% improvement in the duration of survival for the GVAX(R) vaccine treatment arm. Cell Genesys received a SPA from the FDA for this trial in May 2004. Approximately 70 clinical trial sites in the Unites States are now open and patient accrual is ongoing.
The second trial (VITAL-2), for which the above-mentioned SPA was recently granted, is expected to begin in the near future and will enroll symptomatic patients with cancer-related pain and will compare GVAX(R) vaccine plus Taxotere(R) chemotherapy to Taxotere(R) chemotherapy plus prednisone with respect to a survival benefit. The VITAL-2 trial is also expected to enroll 600 patients and is designed to demonstrate a 33% improvement in the duration of survival for the GVAX(R) vaccine plus Taxotere(R) treatment arm. Both the VITAL-1 and VITAL-2 trials will enroll patients with all levels of Gleason scores (a measure of the aggressiveness of prostate cancer) including the highest risk patients.
The Company has conducted two Phase 2 trials of GVAX(R) vaccine for prostate cancer in patients with hormone refractory metastatic prostate cancer. At the May 2005 American Society for Clinical Oncology (ASCO) meeting, the company reported updated results from its second trial which indicated that in 22 patients receiving a dosing regimen comparable to that being used in Phase 3, the median survival has not yet been reached and will meet or exceed 24.1 months based on the median follow-up time in these patients. In September 2002, the company reported final results from its earlier trial of the vaccine in hormone refractory metastatic prostate cancer in which a median survival of 26.2 months was observed in 34 patients receiving vaccine treatment. These results compare favorably to the median survival of 18.9 months for hormone-refractory metastatic prostate cancer patients who were treated with Taxotere(R) plus prednisone based on a recently reported multi-center Phase 3 trial.
Clinical trials of GVAX(R) cancer vaccines are under way for multiple types of cancer including prostate cancer, lung cancer, pancreatic cancer, leukemia and myeloma. Cell Genesys' GVAX(R) cancer vaccines are whole-cell vaccines which are designed to stimulate an immune response against the patient's tumor. The vaccines 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. 
- U.S. Food and Drug Administration (FDA)
www.cellgenesys.com
Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms -- GVAX(R) cancer vaccines and oncolytic virus therapies. Clinical trials of GVAX(R) cancer vaccines include an ongoing Phase 3 trial of GVAX(R) vaccine for prostate cancer as well as trials of GVAX(R) vaccines for leukemia, pancreatic cancer, lung cancer and myeloma. Clinical programs of oncolytic virus therapies currently include CG7870 for prostate cancer and CG0070 for bladder cancer. Cell Genesys continues to hold equity interests in its two former subsidiaries -- Abgenix, Inc., an antibody products company and Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. 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 http://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, agreements with the FDA 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, potential changes in study protocols, new concerns of safety not previously known, regulatory agreements for manufacturing controls and product testing requirements, 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 for the year ended December 31, 2004 dated March 14, 2005, 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.
Contact: Ina Cu
Investor Relations
650-266-3200
CONTACT: Ina Cu, Investor Relations of Cell Genesys, +1-650-266-3200
Web site: http://www.cellgenesys.com/
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