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RCT Patents Oral Immunoglobulin Treatment

8.9.2000

Tucson, AZ – Aug 09, 2000

Research Corporation Technologies (RCT) has patented an oral formulation of immunoglobulin that could become a significant new drug for treating rheumatoid arthritis.

U.S. Patent No. 6,090,380 issued recently to RCT for a method of treating rheumatoid arthritis by oral administration of pooled human immunoglobulin. Currently, the U.S. Food and Drug Administration has approved immunoglobulin as an intravenous or intramuscular injection for temporary resistance against hepatitis A, measles and varicella-zoster infections.

Initial clinical studies supported by Protein Therapeutics, a Tucson company developing nontoxic therapies for chronic autoimmune diseases, show oral immunoglobulin is a safe and effective treatment for rheumatoid arthritis. Protein Therapeutics has an exclusive license to the technology from RCT, which manages the technology for the University of California in Los Angeles, and Dr. Richard Weisbart, a physician and professor of medicine at UCLA and the Sepulveda Veterans Administration Hospital. Weisbart and colleagues found that orally administered immunoglobulin alleviates the symptoms of severe rheumatoid arthritis with no signs of toxicity.

Rheumatoid arthritis is a crippling disease that affects about 2.1 million people in the United States alone (Arthritis Foundation, 2000). Current therapies focus on treating swelling, pain and stiffness with aspirin and nonsteroidal anti-inflammatory drugs or modifying the disease with steroids and immunosuppressants.

Although the exact mechanism is unknown, orally delivered immunoglobulin may act at an initiation site of rheumatoid disease and stop its progression instead of merely suppressing symptoms. Previous research suggests rheumatoid arthritis may be an autoimmune response activated by super antigens that overstimulate the immune system. Studies show intravenous immunoglobulin is somewhat effective against rheumatoid arthritis, but as a treatment it is impractical because the dose is large and the benefits are unsustained.

Weisbart reasoned the effectiveness of immunoglobulin is diminished because intravenous administration delivers the drug to the wrong site. He believes administering the drug orally delivers it to the mucous membrane of the small intestine, where the initiation of disease may occur.

Protein Therapeutics plans to seek FDA approval of the treatment after completing additional human clinical trials at several select rheumatology centers with its new form of the inexpensive drug.

Contact

For more information, contact Leon E. Barstow, Ph.D., President, Protein Therapeutics, 9040 S. Rita Road, Suite 1100, Tucson, AZ 85747-9159, phone (520) 574-1632, fax (520) 663-3593.