The FDA on Friday granted Cellcor Inc. orphan drug status for itsautolymphocyte therapy (ALT) in the treatment of kidney cancer.Under the current Orphan Drug Act, the status means Cellcor wouldhave exclusive rights to market ALT for seven years upon gettingapproval for the cellular therapy from the FDA.The law, which is the focus of proposed amendments in the U.S. Houseand Senate, is aimed at boosting development of drugs for diseasesaffecting less than 200,000 people.Cellcor president and CEO Richard D'Antoni said this is the first timeorphan drug status has been granted to a cellular therapy for a specificdisease."It's significant because it's one more step in our primary goal ofgetting ALT through the approval process for kidney cancer,"D'Antoni told BioWorld. "And the other significance is that it showsthat cellular therapies are products."ALT is undergoing pivotal Phase III trials at 20 sites for treatment ofadvanced kidney cancer. D'Antoni said those trials could be completedby the first or second quarter of next year. The objective of the studiesis to evaluate the survival of patients who receive either ALT or alphainterferon.ALT is an ex vivo procedure designed to activate the patient's immunesystem. The technology involves removing white blood cells from thepatient and then isolating and activating the killer and helper T cells.The activated cells are infused back in the patient."When they (activated T cells) are returned (to the patient) we believethey will search out and destroy foreign targets, such as cancers andviruses," D'Antoni said.The procedure, he added, is done on an out-patient basis and theinfusion of the activated T cells takes 15 to 30 minutes.In an earlier Phase III study, results released in 1990 showed thatkidney cancer patients receiving ALT survived 2.5 times longer thanpatients treated with cimetidine. _ Charles Craig
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