Cellcor Inc. filed an investigational new drug (IND) submission withCanada's Health Protection Branch to expand its Phase III trial ofautolymphocyte therapy (ALT) for treatment of metastatic kidneycancer into Canada. The move also is being used as a first step inseeking regulatory approval there.Cellcor, of Newton Mass., already has an ongoing Phase III trial ofALT at 20 sites in the U.S., and has accrued about 30 of the anticipated180 patients, Richard D'Antoni, Cellcor's president and CEO, toldBioWorld. The first Canadian clinical site will be the Jewish GeneralHospital in Montreal.He said Canadian authorities will consider all previous U.S. data intheir regulatory approval process.Cellcor hopes to have patient accrual completed in the first quarter of1995, and interim trial data available in the first quarter of 1996,D'Antoni said. The trial, to evaluate survival of patients with metastatickidney cancer who receive either ALT or alpha interferon, also willassess quality of life and cost effectiveness, he said. Earlier trialsshowed ALT extended survival to an average of 21 months vs. ninemonths in the control arm.ALT involves growing a patient's own white blood cells in vitro in thepresence of a lymphokine cocktail and antigens to stimulate antibodyproduction. The white blood cells are then reinjected back into thepatient. The procedure is done on an outpatient basis.Chiron Corp., of Emeryville, Calif., has the only approved treatment,Proleukin (IL-2), for metastatic kidney cancer in the U.S. There is noapproved product in Canada. _ Jim Shrine
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