Company Press Release
SOURCE: Biogen, Inc.
Investigators Present Positive Results of Phase II Study of AMEVIVE(TM) (Recombinantly Engineered LFA-1/IgG1 Human Fusion Protein) At a Meeting in London
Biogen Begins Phase III Trials With AMEVIVE(TM) for the Treatment Of Patients With Chronic Plaque Psoriasis
CAMBRIDGE, Mass., Dec. 3 /PRNewswire/ -- Biogen, Inc. (Nasdaq: BGEN - news) announced today 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(TM) in patients with chronic plaque psoriasis.
( Photo: newscom.com )
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(TM), 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(TM) 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(TM) (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(TM) 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(TM) 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(TM)-treated patients. Results indicate that AMEVIVE(TM) cleared psoriasis rapidly and to a significant degree. In particular, patients who received either of the two higher doses of AMEVIVE(TM) 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 Charles N. Ellis, M.D., Professor and Associate Chair, Department of Dermatology at the University of Michigan, showed that patients treated with AMEVIVE(TM) 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(TM) has a unique selectivity for memory-effector T cells. The results demonstrate that, in the trial, treatment with AMEVIVE(TM) 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(TM) 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.
In addition to historical information, this press release contains forward-looking statements within the meaning of the ''safe harbor'' provisions of the Private Securities Litigation Reform Act of 1995. Reference is made in particular to statements regarding the therapeutic and commercial potential of AMEVIVE(TM). These statements are based on the Company's current beliefs and expectations as to such future outcomes. Drug development involves a high degree of risk. Success in early-stage clinical trials does not ensure that later-stage or larger scale clinical trials will be successful. Factors which could cause actual results to differ materially from the Company's current expectations include the risk that the product may not show the same therapeutic effect or safety profile in subsequent trials or that problems or delays may arise during clinical trials or in the conduct of such trials or during the development and testing of the commercial manufacturing process and product or in connection with the regulatory approval process if the Company is successful in its clinical trial efforts, as well as the other risks and uncertainties described from time to time in the Company's periodic reports filed with the Securities and Exchange Commission.
Biogen, Inc., winner of the 1998 U.S. National Medal of Technology, is a biopharmaceutical company principally engaged in discovering and developing drugs for human healthcare through genetic engineering. Headquartered in Cambridge, MA, the Company's revenues are generated from worldwide sales of AVONEX® (Interferon beta-1a) for treatment of relapsing forms of multiple sclerosis, and from the worldwide sales by licensees of a number of products, including alpha interferon and hepatitis B vaccines and diagnostic products. Biogen's research and development activities are focused on novel products for multiple sclerosis, inflammatory, respiratory, kidney and cardiovascular diseases and in developmental biology and gene therapy. For copies of press releases and additional information about the Company, please consult Biogen's Homepage on the World Wide Web at biogen.com.
SOURCE: Biogen, Inc. |
