If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Long Term Gamma Interferon Effective in Atopic Dermatitis PALO ALTO, Calif.-- Feb. 26, 1997—Long-term gamma interferon has been shown to be significantly effective in reducing the symptoms of atopic dermatitis in adults and children. The clinical trial data, which support previous clinical safety and efficacy results, were presented at the American Academy of Allergy Asthma and Immunology Meeting being held in San Francisco by Lynda C. Schneider, M.D. of the Division of Immunology, Children's Hospital, Harvard Medical School. The data were generated in an open-label study in 14 atopic dermatitis patients who previously completed a 12-week, double-blind, placebo-controlled trial of gamma interferon. Eight of the 14 patients were under the age of 16 years old. All patients completed at least 22 months of therapy and were monitored every three months for safety and efficacy. Efficacy was measured by evaluation of total body surface area involvement of disease and clinical severity scores for erythema (redness of the skin), edema (swelling), pruritus (itching), excoriations (scratch marks), scaling and accentuation of skin markings. The results indicated that all parameters of clinical severity were statistically significantly improved following two years of gamma interferon therapy. The amount of skin area affected by disease before gamma interferon therapy averaged 62 percent, while after therapy the amount of skin involvement was reduced to approximately 19 percent. Side effects were minimal and no significant changes in the safety profile were apparent after two years chronic use. "These results are particularly encouraging as we near completion of our Phase III clinical trial of gamma interferon in severe atopic dermatitis," said W. Scott Harkonen, M.D., senior vice president of Product Development and Operations at Connective. "It is our goal to report data from the Phase III trial by year end and, with positive results, plan to submit an application with the FDA to begin marketing gamma interferon in the United States for the treatment of atopic dermatitis." The data are consistent with earlier results published in the Journal of the American Academy of Dermatology from a 12-week, double-blind, placebo-controlled Phase II trial. In the study, patients who received gamma interferon experienced statistically significant improvement of overall disease severity, erythema and excoriations/erosions compared to those patients who received placebo. Atopic dermatitis is a common, recurring inflammatory skin disease, which in its severe form, can result in hospitalization, physical disfigurement and significant quality of life impairment. Recent market studies estimate that over 1.8 million individuals in the United States are afflicted with the disease, of which more than 100,000 patients suffer from the severe form. Current treatments provide only modest benefits and are associated with significant long-term side effects. Gamma interferon is a protein involved in the regulation of the immune system. Because of its biological properties, Connective Therapeutics Inc. is initially developing gamma interferon for the treatment of atopic dermatitis and keloids. Genentech currently markets gamma interferon under the tradename Actimmune(R) (Interferon gamma - 1b) for the treatment of chronic granulomatous disease, a disease indication outside of Connective's licensed field. Connective Therapeutics Inc., headquartered in Palo Alto, is focused on the acquisition, development and marketing of products in the areas of rheumatology and dermatology.
|
