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Cell Genesys reports antitumor activity in Phase I/II GVAX lung cancer vaccine trial

hance 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. GVAX vaccines have demonstrated objective evidence of antitumor activity in all five types of cancer in which they have been testedlung, prostate, pancreatic, kidney and melanomaas 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 for which the interim results were reported 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 tolerateda 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 interim trial results also demonstrate that GVAX lung cancer vaccine induces an anti-lung cancer cellular immune response as well as the formation of new anti-lung cancer antibodies in the blood.

Update on Initial Trial of GVAX Lung Cancer Vaccine

An earlier Phase I/II trial of GVAX lung cancer vaccine in patients with advanced non small-cell lung cancer which was 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 Conferen
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Contact: Todd Ringler
tringler@fkhealth.com
617-761-6791
Feinstein Kean Healthcare
12-May-2001


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