Cell Genesys, Inc. has reported data from a Phase 2 clinical trial of Gvax vaccine for lung cancer, a patient-specific vaccine for patients with advanced-stage, non small-cell lung cancer (NSCLC).

The trial, which is the second Phase 2 trial in this indication, enrolled 101 patients who were randomized to receive vaccine with or without low-dose cyclophosphamide, a chemotherapeutic agent that has been shown to enhance immune response at low doses. Vaccine was prepared from the patient's own tumour obtained through various surgical procedures.

Available data from 52 patients who have initiated vaccine treatment showed that one patient with adenocarcinoma of the lung had a near complete response and remains progression free for more than 16 months after treatment. Fourteen other patients had stable disease. Median overall survival was 5.4 months for the vaccine-only treatment arm and 9.5 months for the cyclophosphamide-plus-vaccine treatment arm, a difference that was not statistically significant.

Cell Genesys recently announced that it would discontinue further clinical development of Gvax vaccine for lung cancer in order to focus its resources on the development of its non patient-specific vaccine products for prostate cancer, leukaemia and pancreatic cancer. While promising early results have been reported for Gvax vaccine for lung cancer, new effective therapies for lung cancer have recently been approved which are relatively easy to manufacture compared to patient-specific vaccine products. The company believes that patient-specific vaccine products such as Gvax vaccine for lung cancer will therefore face a more challenging development and commercialization path.

Clinical trials of Gvax cancer vaccines are under way for multiple types of cancer including prostate cancer, leukaemia and pancreatic cancer. Gvax vaccines are whole-cell vaccines that are designed to stimulate an immune response against the patient's tumour. The vaccines are comprised of tumour cells that have been genetically modified to secrete GM-CSF, an immune stimulatory hormone that plays a key role in stimulating the body's immune response to vaccines and are being developed as non patient-specific "off-the-shelf" pharmaceutical products.

Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms – Gvax cancer vaccines and oncolytic virus therapies. Ongoing clinical trials include a Phase 3 trial of Gvax vaccine for prostate cancer, Phase 2 trials of Gvax vaccines for leukaemia and pancreatic cancer, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer and potentially other types of cancer.