June 20, 2002
Biogen, Inc., (BGEN) announced that the company is launching an international multicenter study to determine the long-term safety, tolerability and efficacy of its multiple sclerosis drug Avonex (Interferon beta-1a) compared with Serono S.A.'s Rebif (Interferon beta-1a). Heading the research initiative as the principal investigator is Thomas J. (Jock) Murray, MD, of Dalhousie University, Halifax, Canada. Murray is Director of the Dalhousie MS Research Unit and Professor of Medical Humanities.
Commenting on the clinical initiative, Murray said, "This study will be the first to evaluate the effect of these two interferon therapies over a sustained and long period of time in patients with relapsing multiple sclerosis. We will approach the clinical initiative in two ways. One phase of the study will be a retrospective analysis of patients who have been on either Avonex or Rebif therapy for a period of time. The second phase of the study will follow these patients and others for and additional 3 years, thus following them for a total of up to five years to evaluate the long term effect of therapy on the disease."
The two-phase study will first evaluate patients who have been on therapy for a minimum of 15 and a maximum of 21 months prior to enrollment into the trial and have an Expanded Disability Status Scale (EDSS) score between 0.0 and 5.5. EDSS is an established neurological scale that measures physical disability. The patients will be divided into two groups, one which includes patients who were treated with a 30 mcg dose of Avonex administered intramuscularly once a week and another which includes patients treated with 44 mcg of Rebif administered subcutaneously three times a week. These patients will also be followed for an additional 3 years to evaluate the long-term efficacy of Interferon beta-1a therapy on a number of clinical and MRI measures.
Murray added, "I am excited to begin work on this much needed comparative study that will provide reliable and valuable information on Avonex and Rebif over a broad spectrum of clinical disease measurements. With five years of data, from a comprehensive, controlled study, this research will help clinicians and patients make the most appropriate treatment choices for MS.
"Although there has been a lot of talk in the MS community lately about comparative clinical studies, those studies were conducted for short periods of time and looked only at narrow measures of efficacy. We don't know the impact on safety or efficacy from long-term frequent dosing with Interferons. I believe that only long-term studies can determine how these MS therapies truly work in this life-long chronic disease."
The study's clinical research team will include neurologists and other MS researchers. Cary Pfeffer, Biogen's Vice President of Global Medical Affairs said, "As the leader in MS treatment and research, Biogen is committed to supporting this important new research. We look forward to bringing both physicians and patients a real life analysis of these MS treatments." This article was prepared by Drug Week editors from staff and other reports.
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