Cellcor Inc. announced last week that the FDA has authorizedthe company to start a pivotal Phase III clinical trial of itsautolymphocyte therapy (ALT) in patients with metastaticrenal cell carcinoma or kidney cancer.
The primary objective of the multicenter, U.S.-based trial is toevaluate the survival of patients with renal cell carcinoma whoreceive either ALT or alpha interferon (Hoffmann-La Roche'sRoferon-A). The company (NASDAQ:CLTX) plans to recruit 180patients for the trial.
Cellcor's ALT is an ex vivo procedure that is intended toactivate the patent's immune system. It's also done on anoutpatient basis. The procedure involves growing a patient'sown white blood cells in vitro in the presence of a lymphokinecocktail and antigens to stimulate antibody production; theactivated cells are then returned to the patient.
The cellular therapy had been considered a medical procedureuntil February, when the FDA's Center for Biological Evaluationand Review established a division of cellular and genetherapies to establish relevant regulations specifically for thistype of therapy.
Cellcor of Newton, Mass., believes that its ALT is the firstcellular therapy that FDA has authorized for Phase IIIs since itcreated the new division.
-- Jennifer Van Brunt Senior Editor
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