Cell Genesys Updates Clinical Data from Phase I/II GVAX(R) Lung Cancer Vaccine Trial
FOSTER CITY, Calif., Dec. 17 /PRNewswire/ -- Cell Genesys, Inc. (Nasdaq: CEGE - news) today reported further clinical data from its multicenter Phase I/II GVAX® lung cancer vaccine trial which demonstrated a complete tumor response rate of twelve percent and a median response duration of greater than 11 months in patients with advanced non small-cell lung cancer who have failed chemotherapy and/or radiation therapy. These data were presented on behalf of the GVAX® Lung Cancer Clinical Investigators by Kristen Hege, M.D., senior director of clinical research at Cell Genesys, at the International Conference of Gene Therapy of Cancer Meeting in San Diego, Calif.
The multicenter clinical trial reported by Cell Genesys included 36 evaluable patients divided into two groups -- 26 patients with advanced lung cancer who failed prior therapy and ten patients with early-stage lung cancer who were felt to be at high risk for recurrent tumor following surgical resection of their cancer. Of 26 patients with advanced-stage lung cancer, three patients, who had failed chemotherapy and/or radiation therapy, achieved a complete response -- complete disappearance of metastatic tumors following treatment with GVAX® lung cancer vaccine -- two of which are ongoing at 11 and 16 months without further treatment for their cancer. One of the three complete responders maintained a complete response for nine months, but then developed a local recurrence of lung tumor which was successfully treated with surgery, and the patient now continues without further evidence of tumor. In addition to these complete responses, seven patients (27 percent) achieved stable (non-progressive) disease with a median duration of at least six months or greater. Included among these seven patients is one patient who achieved approximately a 30 percent total reduction in tumor size, which is continuing after 14 months without further treatment.
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 twelve months. These patients also received no further treatment for their cancer after receiving GVAX® vaccine and continue to be monitored for recurrent cancer.
``We are very pleased to report these updated clinical data for our GVAX® lung cancer vaccine, particularly with respect to the duration of the complete responses which are very unusual in patients with advanced lung cancer who have failed chemotherapy,'' stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. ``Based on these encouraging findings, GVAX® lung cancer vaccine is expected to be the first of three potential Cell Genesys products to enter Phase III clinical trials during the next 12 to 18 months.''
An interim report of this Phase I/II trial of GVAX® lung cancer vaccine for which these updated results were reported, was presented at the American Society of Clinical Oncology (ASCO) Meeting held in May 2001. In this trial, patients were administered up to six vaccine treatments every other week for approximately three months as an intradermal (under the skin) injection. Patients received no other anticancer treatments during the trial evaluation period. As has been demonstrated in all GVAX® cancer vaccine trials to date, the vaccine was shown to be safe and well tolerated with the only consistent side effects being inflammation at the vaccination site and occasional low grade fever -- a side effect profile which compares favorably to other cancer treatments such as chemotherapy. No dose limiting toxicities have been observed. In addition to the antitumor activity noted above, the trial results also demonstrate that GVAX® lung cancer vaccine induces immune responses against lung cancer cells as well as the formation of new anti-lung cancer antibodies in the blood.
GVAX® lung cancer vaccine is a patient-specific vaccine derived from the patient's own tumor which is obtained by surgical biopsy. In the trial for which the updated data were reported, 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 a separate ongoing Phase I/II multicenter trial initiated in June 2001, the patient's tumor cells are mixed with a non patient-specific GVAX® product which produces GM-CSF and which is manufactured at Cell Genesys. One of these two forms of GVAX® lung cancer vaccine will be selected for Phase III trials which are targeted to begin in late 2002. The company is significantly expanding its manufacturing capabilities in order to produce the GVAX® vaccine product needed for Phase III trials as well as for market launch.
Cell Genesys is currently conducting clinical trials of GVAX® cancer vaccines in five types of cancer including lung, prostate, pancreatic, leukemia and multiple myeloma. GVAX® cancer vaccines are comprised of genetically modified, irradiated tumor cells which produce GM-CSF for the purpose of stimulating an antitumor immune response. Cell Genesys 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 more than 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® cancer vaccines are under way in prostate cancer, lung cancer, pancreatic cancer, leukemia and myeloma. Clinical stage programs involving oncolytic viruses include CG7060 and CG7870 in prostate cancer. Preclinical programs include gene therapies and oncolytic virus therapies for multiple types of cancer as well as gene therapy for hemophilia. Cell Genesys' majority-owned subsidiary, Ceregene, is focused on gene therapies for neurologic disorders. Cell Genesys also continues to hold a 10.5 percent equity interest in its former subsidiary, Abgenix, an antibody products company. 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 and reports of GVAX® clinical trials and progress and reports of preclinical programs, 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, manufacturing capabilities, the success and results of clinical trials, the regulatory approval process, competitive technologies and products, patents 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 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
Corporate Communications
650-425-4542
SOURCE: Cell Genesys, Inc. |
