The data were presented on behalf of Cell Genesys, Inc. GVAX® Lung Cancer Clinical Investigators by John Nemunaitis, M.D. of U.S. Oncology at the American Society of Clinical Oncology (ASCO) Meeting in San Francisco, Calif.

The presentation was one of 17 selected, from the more than 3,300 submitted to the meeting, for ASCO's Official Press Program.

The interim clinical trial data includes results on 30 currently evaluable patients with advanced or early-stage lung cancer. Of 22 patients with advanced-stage lung cancer, three patients, two of whom had failed chemotherapy and one who failed radiation therapy, showed a complete disappearance of metastatic tumors following treatment with GVAX® lung cancer vaccine.

One other patient who had failed radiation and chemotherapy had partial (greater than 50 percent) reduction in his tumor. In addition to these major responses, four patients currently have stable (non-progressive) disease.

All of these responses are continuing, with a median follow-up time of approximately five months. In addition to the responses in patients with advanced disease, seven of eight patients with early-stage lung cancer who received GVAX® vaccine following surgery currently remain free of disease, with a median follow-up time of seven months.

"We are very encouraged by what we have seen to date with GVAX® lung cancer vaccine, particularly with respect to the major tumor responses in patients with metastatic lung cancer who have failed chemotherapy," stated Dr. Nemunaitis. "These findings are all the more noteworthy given that lung cancer patients who fail chemotherapy have little chance of responding to further chemotherapy or other treatment."

"These exciting clinical results with our GVAX® lung cancer vaccine are yet another reason we have increased our investment in the clinical and manufacturing development required to bring a GVAX® product to market," stated Joseph J. Vallner, Ph.D., executive vice president and chief operating officer of Cell Genesys.

Dr. Vallmer added, "GVAX® vaccines have demonstrated objective evidence of antitumor activity in all five types of cancer in which they have been tested -- lung, prostate, pancreatic, kidney and melanoma -- as well as a very favorable safety profile compared to chemotherapy, which has been documented in over 300 patients treated to date."

The currently ongoing Phase I/II trial of GVAX® lung cancer vaccine has recently completed enrollment. A final report on the trial is expected during the next year.

In this trial, patients were administered up to six vaccine treatments every other week for 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 -- a side effect profile that 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 interim trial results also demonstrate that GVAX® lung cancer vaccine induces an anti-lung cancer cellular immune response and formation of new anti-lung cancer antibodies in the blood.

An earlier Phase I/II trial of GVAX® lung cancer vaccine in patients with advanced non small-cell lung cancer, conducted by Dr. Glenn Dranoff and colleagues at Dana-Farber/Partners Cancer Care, an affiliate of Harvard Medical School, was reported at the Ninth World Conference on Lung Cancer in Tokyo, Japan in September 2000.

This trial demonstrated antitumor immunity in 18 of 25 patients. In addition, two patients who received GVAX® lung cancer vaccine following surgery remain in complete remission more than three years after GVAX® treatment.

The GVAX® lung cancer vaccine trials to date, including the current study, have employed a patient-specific product format in which the vaccine is prepared directly from the patient's own tumor cells in an overnight process.

In the near future, Cell Genesys plans to launch a clinical trial in advanced lung cancer to evaluate a non patient-specific GVAX® product which will be centrally manufactured by Cell Genesys and then mixed with patients' own irradiated tumor cells prior to vaccination.

This new product format for GVAX® lung cancer vaccine is expected to have significant development and commercialization advantages compared to the first-generation product used in the trial reported yesterday.

Given the encouraging results demonstrated in ongoing clinical trials for prostate and pancreatic cancer, Cell Genesys is emphasizing non patient-specific GVAX® products which can be developed and commercialized as "off-the-shelf" pharmaceuticals.

GVAX® cancer vaccines are comprised of tumor cells which have been 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 then irradiated for safety and used to vaccinate patients to stimulate an immune response against their tumor.

The company's lead GVAX® cancer vaccine program targets patients with recurrent hormone refractory prostate cancer and is currently being evaluated in two multicenter Phase II trials.

A series of Phase I/II trials was recently initiated utilizing the company's new high-potency GVAX® prostate cancer vaccine. Additionally, a Phase I/II trial for GVAX® vaccine for myeloma was recently initiated, and a Phase II trial of GVAX® pancreatic cancer vaccine and a Phase I/II trial of GVAX® vaccine for leukemia are expected to commence in mid 2001.

Cell Genesys is focused on the development and commercialization of cancer vaccines and gene therapies to treat major life-threatening diseases. The company is conducting clinical trials of GVAX® cancer vaccines in prostate cancer, pancreatic cancer, lung cancer and myeloma and expects to initiate new studies in acute leukemia during 2001.

Preclinical stage programs include gene therapies for cancer, hemophilia and cardiovascular disorders. Cell Genesys' majority-owned subsidiary, Ceregene, is focused on gene therapies for central nervous system disorders. Cell Genesys also continues to hold a 10.5 percent equity interest in its former subsidiary, Abgenix, an antibody product company.

Related website:

Cell Genesys, Inc.

14-May-2001