Orphan Drug Status For Cellcor's ALT

The US Food and Drug Administration has granted Orphan Drug designation to Cellcor Inc's Autolymphocyte therapy (ALT) for the treatment of renal cell carcinoma. ALT is a cellular therapy that is the subject of a Phase III pivotal trial being conducted in advanced kidney cancer at over 20 sites.

Under the Orphan Drug Act, a sponsor of an approved drug enjoys exclusive approval for that drug for the orphan indication for seven years following the date of the drug's marketing approval. Cellcor says it believes this is the first instance in which the FDA has granted Orphan Drug status for a particular indication to a cellular therapy.

ALT is the ex vivo general activation of killer and helper T cells which, when returned to the patient, are believed to search out foreign targets (cancer or virus). An earlier Phase III clinical trial in advanced kidney cancer at five US sites published in The Lancet reported ALT's potential to extend survival. Patients who received ALT on an outpatient basis remained functional and productive, the company notes.