Cell Genesys Reports Encouraging Update From Initial Clinical Trial of GVAX(R) Lung Cancer Vaccine
Thursday February 13, 6:05 pm ET
GVAX(R) Report is 'Featured Article' in Journal of Clinical Oncology
FOSTER CITY, Calif., Feb. 13 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE - News) today reported updated data from the initial Phase I/II clinical trial of GVAX® lung cancer vaccine, a patient-specific vaccine made directly from patient tumor biopsies. Data from this early trial, which involved patients with advanced non small-cell lung cancer (NSCLC), the majority of whom had failed prior treatment with surgery, radiation and/or chemotherapy, were last updated in September 2000. Eighteen of 22 patients who completed the entire course of vaccinations demonstrated enhanced antitumor immunity as measured by delayed-type hypersensitivity (DTH) skin reactions following treatment with GVAX® lung cancer vaccine. In addition, two patients continue to experience disease-free survival at least 3.5 years after treatment, one of whom has bronchoalveolar carcinoma (BAC), a subtype of NSCLC which may be more responsive to GVAX® lung cancer vaccine. Five additional patients were reported to have stable disease with no evidence of tumor progression for up to 33 months (median duration = 12 months). Treatment with GVAX® vaccine was safe and well tolerated in the outpatient setting. This paper by Glenn Dranoff, M.D. and colleagues at the Dana-Farber Cancer Institute was the featured article in the February 15th issue of the Journal of Clinical Oncology -- the official journal of the American Society of Clinical Oncology.
"We continue to be encouraged by the data we have seen from clinical trials of GVAX® lung cancer vaccine and other product candidates from our GVAX® cancer vaccine product platform," stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "These updated data and data from other GVAX® cancer vaccine trials further reinforce our plans to advance these product candidates into late-stage development, beginning with the initiation of a Phase III clinical trial of GVAX® prostate cancer vaccine in mid-2003."
Subsequent to the trial reported above, Cell Genesys initiated a multicenter Phase I/II clinical trial of GVAX® lung cancer vaccine in patients with advanced NSCLC. Encouraging data from this trial were recently updated at the December 2002 International Conference on Gene Therapy of Cancer. Of 33 treated patients, the majority of whom had failed prior chemotherapy and/or radiation therapy, three patients (9 percent) experienced complete responses (complete disappearance of tumor) with a median duration of response of 17.8 months. Additionally, one of the complete responses was reported to be ongoing at 21.7 months. Of these three patients, two were noted to have BAC and were among only three patients with this diagnosis entered on the trial. The median survival of all 33 treated patients was 8.6 months (not including the time required to manufacture their vaccines). These data compare favorably to the reported median survival of 5.7 to 7.0 months for the approved second-line chemotherapy (docetaxel) for such patients or 4.6 months for best supportive care. Moreover, median survival was significantly longer in patients whose vaccine products secreted higher levels of GM-CSF, an immune stimulatory hormone, which all GVAX® vaccines are engineered to produce (median survival of 15.7 months for GM-CSF >40 ng./10(6) cells/24 hr. versus median survival of 5.8 months for GM-CSF <40ng./10(6) cells/24 hr., p= .04).
In follow-up to the results of these Phase I/II trials, Cell Genesys plans to initiate two Phase II clinical trials of GVAX® lung cancer vaccine -- one which is expected to be sponsored and partially funded by the Southwest Oncology Group (SWOG), a cooperative clinical trials group of the National Cancer Institute (NCI), and the other which will be sponsored by Cell Genesys. The SWOG-sponsored trial will focus on patients with BAC to further explore the possibility that this type of NSCLC may be particularly responsive to GVAX® lung cancer vaccine therapy. The company-sponsored trial will enroll patients with all subtypes of NSCLC and patients will be randomized to receive GVAX® lung cancer vaccine with or without low-dose cyclophosphamide, a chemotherapeutic agent which in the doses to be employed has been shown to enhance the immune response. The two trials are expected to treat approximately 75 patients each and are expected to begin within the next few months. Data from these trials could be part of future regulatory filings for product approval. A Phase III clinical trial of GVAX® lung cancer vaccine in patients with all types of NSCLC is targeted to begin at the end of 2003.
In December 2002, Cell Genesys announced that it had completed construction of its 35,000 square-foot GMP (good manufacturing practices) facility located in Memphis, TN. This facility, which will be used primarily to manufacture GVAX® lung cancer vaccines for future clinical trials and potential subsequent market launch, is currently undergoing validation testing. In addition, the company has developed a semi-automated closed system that it expects to use to manufacture its patient-specific GVAX® lung cancer vaccines, which has been designed to enable the safe and sterile manufacturing of each patient's vaccine. Memphis is centrally located within the United States and is widely recognized as one of the major shipping hubs in the world. Cell Genesys believes these two factors will help facilitate the receipt of patient tumor specimens and the distribution of the patient- specific cancer vaccines to treatment centers throughout the United States.
Cell Genesys' GVAX® 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. GVAX® cancer vaccines have demonstrated antitumor effects against every type of human cancer against which they have been tested to date, and the company is currently evaluating these products in five types of cancer -- prostate, lung, pancreatic, leukemia and myeloma. Currently, Cell Genesys is evaluating non patient-specific, off-the-shelf GVAX® vaccines for prostate cancer and pancreatic cancer and patient- specific, individualized vaccines for lung cancer, leukemia and myeloma. With all tumor types and vaccine formats tested, GVAX® cancer vaccines have demonstrated a favorable side effect profile and have been safely administered to over 500 patients to date.
Cell Genesys is focused on the development and commercialization of innovative biological therapies for 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 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 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 April 1, 2002 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: Jennifer Cook Williams, Director, Corporate Communications, of Cell Genesys, Inc., +1-650-425-4542/
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Source: Cell Genesys, Inc. |
