Somatix Therapy Corp. announced Tuesday that theRecombinant DNA Advisory Committee (RAC) of the NationalInstitutes of Health (NIH) has approved its gene therapyprotocol for treating advanced renal cancer.

The protocol, which the Alameda, Calif., company(NASDAQ:SOMA) has developed in collaboration with The JohnsHopkins Oncology Center and the Whitehead Institute forBiomedical Research, involves a treatment designed tostimulate the body's own immune system to selectively destroycancer cells by vaccinating patients with their own geneticallymodified tumor cells.

The procedure entails removing the tumor, introducing into thetumor cells via retroviral vector the cDNA for the lymphokinegranulocyte macrophage-colony stimulating factor (GM-CSF),irradiating the cells so they can't reproduce, and then injectingthe modified cells back into the patient to generate a systemicimmune response to any remaining tumor cells.

Engineering the tumor cells to express GM-CSF "seems tostimulate the presentation of tumor-specific antigens to theimmune system," said Bob Kuhn, Somatix's director ofbiochemistry. This would allow for the elimination from thebody of any tumor cells with these same antigens. As well, inthe presence of GM-CSF (as opposed to any of 12 otherbiological compounds the researchers tested in this system),"the immune response has a memory component which isimportant if similar tumors arise later," Kuhn said.

"Now that we have RAC approval," said David Carter, Somatix'spresident and chief executive officer, "we will focus onpreparing and filing an investigational new drug (IND)application with the FDA." Trials in patients could begin by theend of the summer, added Kuhn.

Somatix's stock closed Tuesday at $7.25 a share, up $1.38.

-- Jennifer Van Brunt Senior Editor

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