New Biologic Treatment Appears To Demonstrate Lasting Benefit For Chronic Psoriasis

Salt Lake City, UT (March 19, 2001) -- Researchers at the University of Utah School of Medicine's Department of Dermatology recently announced the results of a clinical trial where alefacept (human LFA-3 IgG1 fusion protein, AMEVIVE(tm)) was given to patients with psoriasis who had previously been treated with alefacept. Previous studies have shown that alefacept induced a sustained response for patients with psoriasis. Alefacept, an immunomodulator that specifically targets a subset of lymphocytes that play a pivotal role in causing psoriasis, has been shown to be a safe and effective treatment for patients with moderate to severe chronic psoriasis. The trial reported that successive treatments with alefacept demonstrated positive results similar to that of the initial course of treatment and that patients maintained their clinical improvement between five and 17 months after a course of therapy. Detailed study results are scheduled for publication within the next six months.

This phase II study included 174 patients who had been on previous studies with this drug; 88 of these patients also received a second retreatment course. The data showed that approximately half of the patients achieved at least a 50 percent or greater reduction in Psoriasis Area and Severity Index (PASI). These findings were consistent with clinical response to alefacept after the initial course of treatment. There were also no reported incidents of rapid recurrence or disease rebound, a condition where a patient's psoriasis becomes substantially more severe once treatment is withdrawn.

"This data is significant for patients who suffer from chronic psoriasis because many current treatments have significant and cumulative side effects," says Dr. Gerald Krueger, M.D., Professor of Dermatology, University of Utah School of Medicine and a lead investigator on several studies. "This new targeted immunomodulator appears to be safe and effective with few side effects, and provides long-term clearance of psoriasis that continues even when the patient is off the medication. Unlike broader immunosuppressant agents, alefacept appears to knock out causative memory T-lymphocytes. This specific targeted activity may account for the unique lasting duration and safety profile demonstrated to date."

Psoriasis is a T-cell mediated inflammatory disorder of the skin that can cause considerable discomfort. It is a disease for which there is no cure and affects people of all ages. Psoriasis affects approximately seven million Americans. The rash of psoriasis consists of red, scaly areas that commonly occur on the scalp, elbows and knees. In moderate and severe cases, the involved areas can be extensive and cover a substantial percentage of a patient's body. In addition, limited disease can be considered severe if occurring on critical areas such as the palms or soles. Moreover, patients usually have recurrence of psoriasis, and with some treatments prompt recurrence can be expected when treatment is discontinued. According to the National Psoriasis Foundation (NPF), the disease impacts a person's psychological well-being and social functioning, as well as their physical functioning.

The University of Utah School of Medicine has been involved in the research efforts of alefacept for the treatment of psoriasis since the inception of the drug in its first clinical trial in 1995. Researchers at the University's Department of Dermatology are conducting basic research on psoriasis and have made two seminal discoveries in the pathogenesis of psoriasis. One of the department's goals is to continue to conduct clinical trials directed at finding new and innovative therapies for treating psoriasis.

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Media Contacts:Jane Spieler University of Utah (801) 581-6465

Katherine Maynard SPECTRUM Science Public Relations(202) 955-6222