Somatix Therapy Corp. announced Thursday that it haslaunched a Phase I trial of its GVAX gene therapy for advancedkidney cancer. Approximately 24 patients will be enrolled inthe two-arm, double-blind, dose escalation study at The JohnsHopkins Oncology Center.

The GVAX vaccine consists of a patient's own tumor cells thathave been removed and genetically modified to contain thegene for granulocyte macrophage-colony stimulating factor(GM-CSF). The modified cells are irradiated to prevent furtherdivision before being injected back into the patient to stimulatean anti-tumor immune response.

Following surgical removal of the primary tumor, patients willreceive either three doses of GVAX or three doses ofunmodified tumor cells, one month apart. Investigators willevaluate safety and cell dosage and any anti-tumor immuneresponse.

The protocol for the Phase I study was approved by theNational Institutes of Health's Recombinant DNA AdvisoryCommittee in March.

Somatix (NASDAQ:SOMA) of Alameda, Calif., developed theprotocol in collaboration with Johns Hopkins and the WhiteheadInstitute for Biomedical Research. Preclinical data reported inthe April 15 issue of the Proceedings of the National Academyof Sciences showed the ability of the vaccine to confer long-lasting, potent and specific immunity in mouse models ofvarious forms of cancer. -- Brenda Sandburg

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