Somatix Therapy Corp. on Monday announced that it has filed aninvestigational new drug (IND) application with the FDA for itsproprietary GVAX gene therapy product for treating advanced renalcell carcinoma (kidney cancer).
The Recombinant Advisory Committee (RAC) of the NationalInstitutes of Health approved Somatix's gene therapy protocol toevaluate GVAX in kidney cancer patients in March.
GVAX, which Somatix (NASDAQ:SOMA) of Alameda, Calif., isdeveloping as a treatment rather than a vaccine, uses a patient's owngenetically modified tumor cells to stimulate the immune system toselectively attack and destroy remaining or metastatic tumor cellsfollowing the excision of a tumor.
Under the RAC protocol, tumors removed from patients at the JohnsHopkins Oncology Center will be sent to Somatix. The company willintroduce into the tumor cells via retroviral vector the cDNA for thelymphokine granulocyte macrophage-colony stimulating factor (GMCSF), and irradiate the cells so they can't reproduce. The modifiedcells will then be injected back into the patient to generate asystemic immune response to any remaining tumor cells.
The company said it expects to begin patient enrollment shortly forthe Phase I trial. Preclinical studies from which data were publishedin the April 15 issue of Proceedings of the National Academy ofSciences have demonstrated the vaccineUs ability to confer long-lasting, potent and specific immunity in mouse models of variousforms of cancer, the company said.
Somatix said it intends to pursue expanded applications of GVAX totreat additional types of cancer.
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