AtheroGenics Expands Pipeline - Files IND for Novel Drug For Rheumatoid Arthritis
New Compound Validates Proprietary V-Protectant Technology Platform For Expanded Treatment of Chronic Inflammatory Diseases
ATLANTA, Feb. 20 /PRNewswire/ -- AtheroGenics, Inc. (Nasdaq: AGIX - news), an emerging pharmaceutical company, today announced that the company has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration for AGIX-4207, a novel, orally administered drug for the treatment of rheumatoid arthritis. The filing is the first step in initiating a Phase I clinical trial to assess the safety of AGIX-4207 in healthy people.
``The filing of this IND for AGIX-4207 in rheumatoid arthritis represents an important milestone for AtheroGenics,'' said Russell M. Medford, M.D., Ph.D., AtheroGenics' president and chief executive officer. ``It reflects the culmination of successful pre-clinical studies, demonstrating that the company's proprietary v-protectant technology platform has broad application in diseases of chronic inflammation. Because of the unique properties of this oral compound, we are encouraged by the prospect of bringing forward a new therapy for the millions suffering from this debilitating disease.''
Rheumatoid arthritis (RA) is a chronic and progressively debilitating inflammatory disease that affects more than two million adults in the U.S., with an annual impact on the U.S. economy of over $65 billion in direct and indirect costs. Approximately 70 percent of those diagnosed with rheumatoid arthritis are young and middle-aged women. Physicians currently treat chronic RA in a stepwise escalation, starting with the use of anti-inflammatory agents like aspirin or ibuprofen, to the use of increasingly toxic drugs that affect the body's immune system, termed
Disease Modifying Anti-Rheumatic Drugs (DMARDS). New injectible DMARDS, such as Enbrel(TM), target the modulation of Tumor Necrosis Factor (TNFa), a protein that stimulates a broad range of cellular activities implicated in inflammation, tissue repair and proliferation.
Based on AtheroGenics' proprietary v-protectant technology, AGIX-4207 is an orally administered, selective modulator of TNFa, that blocks a subset of TNFa induced activity. By affecting only a portion of the protein activity, AGIX-4207 may decrease chronic inflammation in rheumatoid arthritis and may have fewer side effects.
AtheroGenics' IND for rheumatoid arthritis marks the company's second therapeutic treatment for diseases of chronic inflammation. AtheroGenics' lead compound, AGI-1067, designed as a treatment for patients with coronary artery disease, recently completed dosing in a 300-patient Phase II clinical trial for the treatment of post-angioplasty restenosis. AtheroGenics will report results from this clinical trial during the second quarter.
AtheroGenics, Inc., based in Atlanta, Ga., is focused on the discovery, development and commercialization of novel therapeutics for the treatment of chronic inflammatory diseases such as heart disease (atherosclerosis), rheumatoid arthritis, and asthma. For more information, please visit www.atherogenics.com . |
