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Novel Oral Drug for Rheumatoid Arthritis Completes Phase I Clinical Trial

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www.ProHealth.com • October 26, 2001




AGIX -4207, a novel oral agent being developed for the treatment of rheumatoid arthritis, has completed the escalating single-dose segment of its Phase I clinical trial. This is according to a recent announcement by the drugs manufacturer, AtheroGenics, Inc.

AGIX-4207 is a small molecule drug that represents a unique approach to treating rheumatoid arthritis. Unlike currently marketed biological TNF-alpha (tumor necrosis factor-alpha) inhibitors, AGIX-4207 is a selective modulator of TNF-alpha induced redox-sensitive inflammatory genes. By targeting a specific subset of TNF-alpha activity, it is believed that AGIX-4207 may decrease chronic inflammation in rheumatoid arthritis, while maintaining the body's ability to respond to infection.

The Phase I clinical trial is designed to study the safety, tolerability and pharmacokinetics of single and multiple doses of AGIX-4207 in healthy volunteers. A total of 48 patients in the single-dose segment of the Phase I trial received oral doses of AGIX-4207, ranging from 1mg to 150mg. AGIX-4207 was well tolerated by all patients, and there were no serious adverse events occurring in patients who received the drug. The data have been submitted to the U.S. Food and Drug Administration for review, and a multi-dose segment of the study is expected to be completed by the end of the year.

"We are delighted that AGIX-4207 has successfully completed this first stage of the trial, and we look forward to completing the multi-dosing before the end of this year," said AtheroGenics President and Chief Executive Officer, Russell Medford, M.D., Ph.D. "As we progress through these clinical trial milestones, we remain hopeful that AGIX-4207 might eventually provide those who suffer from rheumatoid arthritis with a safe and effective treatment option for their health and well being."

Rheumatoid arthritis is a chronic and progressively debilitating inflammatory disease that affects more than two million patients in the United States. Approximately 70 percent of those diagnosed with rheumatoid arthritis are young and middle-aged women. Physicians currently treat chronic rheumatoid arthritis in a stepwise fashion, escalating from a regimen of common anti-inflammatory agents like aspirin or ibuprofen, to the use of increasingly toxic drugs that may affect the body's immune system, such as DMARDs (Disease Modifying Anti-Rheumatic Drugs) or biological TNF-alpha inhibitors.



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