Trial Underway of AGIX-4207 for Treatment of Rheumatoid Arthritis

A Phase II clinical trial of AGIX-4207 is underway to test the drug in the treatment of rheumatoid arthritis.

The trial will evaluate the effect of the drug on biomarkers of inflammation in patients currently being treated with infliximab (Remicade). A biomarker is a biochemical in the body that has a specific molecular feature that makes it useful for measuring the progress of a disease or the effects of a treatment for a disease.

The initial Phase I trial, completed in February 2002, showed that AGIX-4207 was safe and well-tolerated.

The Phase II multi-center, double-blind, randomized, placebo-controlled trial will determine the effect of two AGIX-4207 dosages on established biomarkers of rheumatoid arthritis, including erythrocyte sedimentation rate and highly sensitive C-reactive protein.

The trial will evaluate 24 patients who are currently undergoing treatment for rheumatoid arthritis with the prescribed dosing regimen of Remicade.

"Despite the recent advances in the treatment of rheumatoid arthritis, there remains a critical need for alternative treatment options for patients who suffer from this disease," said Dr. Russell M. Medford, President and CEO of AtheroGenics, makers of AGIX-4207. "We believe that AGIX-4207 represents a promising complementary therapeutic candidate for the signs and symptoms of rheumatoid arthritis."

AGIX-4207 is a selective modulator of TNF-alpha induced inflammatory genes, which is a new approach to treating rheumatoid arthritis. TNF-Alpha is a naturally occurring protein involved in the development and progression of many chronic inflammatory diseases, including rheumatoid arthritis. Unlike other drugs of its type, AGIX-4207 does not suppress the immune system, a side effect that can lead to serious infection.

Other sources: AtheroGenics