AtheroGenics Completes Phase I Clinical Trial for Oral Rheumatoid Arthritis Treatment
ATLANTA, Feb. 20 /PRNewswire-FirstCall/ -- AtheroGenics, Inc. (Nasdaq: AGIX - news), a pharmaceutical company focused on the treatment of chronic inflammatory diseases, announced today the completion of a Phase I clinical trial demonstrating the safety of AGIX-4207, its lead oral compound being developed for the treatment of signs and symptoms of rheumatoid arthritis.
The results from this trial demonstrated that AGIX-4207 is well tolerated over the single and multiple dose ranges studied. Adverse events were generally mild and not considered clinically significant. In the multiple dose segment of the study, subjects reached and maintained blood levels in the target range for AGIX-4207, which was set based on results showing efficacy in an animal model of rheumatoid arthritis. AtheroGenics plans to initiate a Phase II efficacy study in patients with rheumatoid arthritis in the second quarter of 2002.
The Phase I trial was an ascending single and multiple oral dose study involving healthy volunteers. A total of 48 subjects received oral doses of AGIX-4207 in the ascending single-dose segment of the trial, ranging from 1mg to 150 mg. A total of 24 healthy volunteers participated in the multiple dose segment of the trial, in which patients received doses of either 75mg or 150mg for seven consecutive days.
``We are pleased that the Phase I study in normal subjects was well executed and achieved the objectives of defining a safe dose range to evaluate in our Phase II program,'' said Russell M. Medford, M.D., Ph.D., AtheroGenics' President and Chief Executive Officer. ``If our further studies prove successful over the next few years, we may have a drug that reduces the underlying inflammation involved in rheumatoid arthritis, rather than treating the symptoms.''
Rheumatoid arthritis (RA) is a condition that involves inflammation of the lining of the joints and/or other internal organs, and affects more than 2.1 million patients in the United States. RA is a systemic disease that affects the entire body and is one of the most common forms of arthritis. It is characterized by progressive inflammation and damage to joints, resulting in pain and potential loss of movement.
Physicians currently treat chronic RA in a stepwise fashion, escalating from a regimen of common anti-inflammatory agents like aspirin or ibuprofen, to the use of increasingly powerful drugs that may affect the body's immune system, which are termed DMARDs (Disease Modifying Anti-Rheumatic Drugs) or biological TNF-alpha antagonists.
AGIX-4207 is a proprietary small molecule drug that represents a novel approach to treating RA. Unlike currently marketed biological TNF-alpha (tumor necrosis factor-alpha) antagonists, 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 in a manner that avoids broad based immune suppression.<snip> |
