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Phase 2 Trial Enrollment Begins for GVAX in Bronchoalveolar Carcinoma

SOUTH SAN FRANCISCO, Calif., June 28 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. today announced that enrollment has been initiated for a multicenter Phase 2 clinical trial of GVAX® lung cancer vaccine in patients with advanced-stage bronchoalveolar carcinoma (BAC), one of the four principal subtypes of non small-cell lung cancer (NSCLC). This trial is being conducted and sponsored by the Southwest Oncology Group (SWOG), a cooperative clinical trials group of the National Cancer Institute. The trial is the second of two Phase 2 studies designed to expand on the encouraging results of an earlier Phase 1/2 trial of GVAX® lung cancer vaccine in advanced, heavily pretreated patients which among other findings suggested that BAC may be particularly responsive to the vaccine. Approximately 100 patients with BAC are expected to be enrolled in the new study at 15 to 20 medical centers across the United States.

In other news, Cell Genesys confirmed that it is in the final stages of preparation of clinical trial sites to initiate the first Phase 3 trial of GVAX® prostate cancer vaccine and that the company is finalizing its efforts to open the study for enrollment during the next month. Cell Genesys recently received a Special Protocol Assessment (SPA) from the Food and Drug Administration (FDA) for this protocol which provided FDA confirmation that the trial design would adequately support a product registration application. This trial, called VITAL-1, will compare GVAX® vaccine to chemotherapy with docetaxel (Taxotere®) plus prednisone in patients with metastatic hormone-refractory prostate cancer with respect to survival benefit. A second Phase 3 trial called VITAL-2, which will compare GVAX® vaccine plus chemotherapy to chemotherapy alone, is currently in the planning stage and is expected to start in the late 2004/early 2005 timeframe.

"We are pleased to collaborate with the Southwest Oncology Group and NCI in the Phase 2 BAC trial and appreciate their support of our GVAX® lung cancer vaccine program," stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "Bronchoalveolar lung cancer is generally less responsive to chemotherapy and therefore represents a subtype of lung cancer for which new treatment strategies are urgently needed."

The results of the previous Phase 1/2 clinical trial of GVAX® lung cancer vaccine in advanced NSCLC that supported the advancement of the product into further clinical development were published in the February 18, 2004 issue of the Journal of the National Cancer Institute. 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. Of these three patients, two were noted to have BAC and were among only three patients with this diagnosis treated in the trial. The median survival of all 33 treated patients was 11.6 months, which compares favorably to the reported median survival for the approved second-line chemotherapy, docetaxel (Taxotere®). These results led Cell Genesys last year to initiate a follow-on Phase 2 trial in all subtypes of NSCLC which has enrolled over 70 patients to date and is expected to complete accrual later this year, as well as the Phase 2 BAC trial announced today.

Unlike the company's other GVAX® vaccine products, all of which are non patient-specific or "off-the-shelf" products, GVAX® lung cancer vaccines are patient-specific vaccines derived from the patient's own tumor. The patient's tumor cells can be obtained using a variety of standard medical procedures. In the case of BAC, which is often confined to the lung, a direct lung biopsy will often be employed. To streamline the vaccine production itself, the company has developed a semi-automated closed system that it is currently being used to manufacture its patient-specific GVAX® lung cancer vaccines for clinical trials. Cell Genesys is now manufacturing GVAX® lung cancer vaccines in its 35,000 square-foot GMP (good manufacturing practices) facility located in Memphis, TN. Memphis is widely recognized as one of the major shipping hubs in the world which will 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 activity against every type of human cancer 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 developing non patient-specific, "off-the-shelf" GVAX® vaccines for prostate cancer, pancreatic cancer, leukemia and myeloma, and a patient-specific, individualized vaccine for lung cancer. GVAX® cancer vaccines have demonstrated a favorable side effect profile in over 600 patients treated in clinical trials to date.

Clinical Trial Enrollment Information

Patients seeking information about how to participate in the GVAX® lung cancer vaccine trial can obtain information by visiting the company's website at http://www.cellgenesys.com/ or by calling 210-677-8808.

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