Oral Interferon in Clinical Trials

Applied Genetics News,  March 19, 1999  

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Calypte Biomedical Corp. (Alameda, CA; Tel: 510/749-5100), through its therapeutic affiliate, Pepgen Corp., will begin phase one clinical trials for its orally ingestable interferon tau for the treatment of multiple sclerosis (MS). The studies will be done in conjunction with Harvard Medical School and its teaching hospitals, Brigham & Women's Hospital and Massachusetts General Hospital.

Revenues from interferon products total about $3 billion annually. However, alpha and beta interferons must be injected either intramuscularly or subcutaneously. These interferons also have significant side-effects, including flu-like symptoms (fatigue, chills, muscle aches, and fever), mild anemia, injection site reactions, depression, anxiety, shortness of breath, and flushing. According to Calypte, not only can interferon tau be taken orally but has far fewer side effects. The focus of the phase one studies will be to determine the safety of interferon tau when taken by MS patients. Current treatments for MS are Avonex (Interferon Beta 1A, marketed by Biogen), Betaseron (Interferon Beta-1b, marketed by Berlex) and Copaxone (glateramer acetate, marketed by Teva Marion Partners). There are between 250,000 and 350,000 people in the U.S. who suffer from MS according to the National Multiple Sclerosis Society. Previously, Pepgen Corp. has studied the ability of interferon tau to prevent the development of experimental allergic encephalomyelitis in mice, an animal disease model similar to human MS. According to the company, not only was the drug very effective, but there was no effect on white blood cells counts. "When mice were administered with interferon alpha or beta, the result was severe lymphocyte depression," says C.P. Liu, founder of Pepgen. "Under prolonged treatment with interferon tau at extremely high doses--equivalent to 90 mg per day in a human patient--there was still no dose-related toxicity." "Now that the compound is being administered to humans, we hope to attract, and have discussions with, larger pharmaceutical firms that can assist in funding the phase two and three human trials, as well as invest in our other endeavors in the HIV arena." says Paul Frieman, a member of Calypte's board, and a former chair and CEO of Syntex Corp.

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