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PHASE II RHEUMATOID ARTHRITIS DRUG TRIAL COMPLETED

October 17, 2005

Researchers at the University of California, San Diego (UCSD) School of Medicine have announced successful completion of Phase II clinical trials of a novel drug for the treatment of rheumatoid arthritis (RA), one that works without suppressing the patient's immune system.

The new drug, dnaJP1, is a peptide derived from a naturally occurring protein, dnaJ, which generates inflammation in RA patients, whose inflammatory-control mechanisms are impaired. The impairment causes the body's T cells -- which trigger inflammation to kill and clear foreign pathogens in the body -- to attack the body's own tissues.

DnaJP1 was found effective in a double-blind, placebo-controlled trial sponsored by the NIH, which took place between 2000 and 2005 and involved 160 patients enrolled in centers nationwide including UCSD, Stanford University, Johns Hopkins University, the Mayo Clinic and Virginia Mason Medical Center in Seattle. Patients received 25 mg of dnaJP1 daily by mouth for six months, and the treatment was found to be safe and well-tolerated. When compared with a placebo, patients in the treatment group experienced lessening of symptoms such as swollen joints, tenderness, pain and decreased mobility.