To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Amevive Provides Therapeutic Effect For Psoriasis URL: http://www.pslgroup.com/dg/14DA66.htm Doctor's Guide December 3, 1999
CAMBRIDGE, MA -- December 3, 1999 -- Biogen, Inc. announced that investigators for the Amevive(TM) (Recombinantly Engineered LFA-1/IgG1 Human Fusion Protein) Clinical Study Group presented positive data from a Phase II clinical study at the Psoriasis: Gene to Clinic Meeting. The presentations were made today at the meeting, which was held in London, England. The company also announced that it has begun a pivotal Phase III clinical trial with Amevive in patients with chronic plaque psoriasis. Jim Vincent, Biogen's Chairman and CEO, said, "Existing therapies for psoriasis are not optimal and often have long-lasting toxicities. We believe that Amevive, which has demonstrated clinically meaningful and statistically significant treatment results, with a favorable safety profile, may offer a novel approach to treating this underserved patient population. Based on very encouraging Phase II results, we moved forward aggressively with Phase III planning in North America and Europe, and this week we initiated registrational studies in the U.S." The Phase II study was a placebo-controlled, randomized, double-blind trial of Amevive in patients with moderate-to-severe chronic plaque psoriasis. It involved 229 patients at 22 sites in the U.S. who were treated with Amevive (at doses of 0.025 mg/kg, 0.075 mg/kg, or 0.15 mg/kg) or placebo by intravenous bolus injection weekly for 12 weeks, followed by a 12-week observation period. The primary study objective was to determine the relationship of clinical response to the dose of Amevive when administered once a week for a total of up to 12 doses. Disease severity was measured by Physician Global Assessment and the Psoriasis Activity and Severity Index, which are the standard measures of severity in psoriasis. Quality of life assessments were obtained using standard instruments. Analysis of the safety and efficacy data from the study, presented at the meeting by Gerald G. Krueger, M.D., Professor of Dermatology at the University of Utah, showed that Amevive was well tolerated with a favorable safety profile and provided significant therapeutic effect. No increase in infection rate or evidence of cytokine-release or capillary-leak syndromes was observed in Amevive-treated patients. Results indicate that Amevive cleared psoriasis rapidly and to a significant degree. In particular, patients who received either of the two higher doses of Amevive demonstrated a statistically significant clearance or almost complete clearance of psoriasis, two weeks after discontinuation of therapy. A dose-related effect was observed. Quality of life data, presented at the meeting in a poster by Dr. Charles N. Ellis, Professor and Associate Chair, Department of Dermatology at the University of Michigan, showed that patients treated with Amevive reported significantly more improvements in skin-related symptoms, role and social function, and emotional well-being as measured by the Dermatology Life Quality Index and the Dermatology Quality of Life Scales relative to patients receiving placebo. In a separate poster presentation, immunopharmacologic data showed that Amevive has a unique selectivity for memory-effector T cells. The results demonstrate that, in the trial, treatment with Amevive reduced the number of these memory-effector T cells, which play an important role in the pathogenesis of psoriasis, but did not reduce naive T cells, indicating that there was not a broad suppression of immune function. Psoriasis is an inflammatory disorder characterized by red, scaly, thick plaques that can cause considerable discomfort. Amevive is believed to work by modulating the activation of the T cells that cause the disease. An estimated one-to-two percent of people in North America and Europe have psoriasis, and as many as one million have the moderate-to-severe form of the disease. Related Link: Biogen, Inc. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.