Tuesday October 5, 8:29 am Eastern Time
Company Press Release
SOURCE: Ares-Serono International S.A.
GENEVA, Oct. 5 /PRNewswire/ -- Ares-Serono International S.A. announced today that it has initiated the first head-to-head study of interferon beta-1a treatment in relapsing-remitting MS to determine if there are any differences between high-dose and low-dose interferon beta therapy in multiple sclerosis (MS). The trial of over 600 patients will compare a 132 mcg weekly dose of Rebif® (44 mcg three times per week), to Avonex®(a) at 30 mcg per week, to determine if Rebif®'s higher-dose formulation offers any patient benefits. Several trials (b,c) have suggested a dose-response effect with Rebif® in the treatment of MS. Until now, however, no studies have directly compared the efficacy of competing products.
``This first comparative trial will shed light on the dose-response effect across products and will be of significant importance for the neurological community worldwide,'' said Hisham Samra, M.D., Head of Clinical Development and Regulatory Affairs at Ares-Serono International S.A., Geneva.
Rebif® is available in 49 countries worldwide, including Canada, the European Union, Switzerland and Latin America. ``There is a great deal of clinical evidence with beta interferon treatments in MS that suggest patients respond better to higher doses,'' said Patricia K. Coyle, MD, professor of neurology at the State University of New York at Stony Brook. ``If this head-to-head trial reinforces what we have seen previously, it will help establish uniform treatment standards.''
The Rebif® vs. Avonex® study is designed to measure standard clinical endpoints including relapses and magnetic resonance imaging (MRI) to measure the amount of disease activity in the brains of each treatment group. MRI can measure disease activity with greater sensitivity and objectivity than clinical assessments.
There is widespread support among the MS community for the head-to-head trial, which has the backing of the National Multiple Sclerosis Society in the U.S. ``This study will provide important information for MS patients and their physicians and will allow a direct assessment of the dose-response theory in use of interferon beta-1a,'' said Stephen Reingold, PhD, Vice President Research of the U.S. National MS Society. ``We eagerly await the results of this study.''
An estimated one to two million people worldwide are living with multiple sclerosis, which is a chronic, debilitating disease of the central nervous system that affects mainly young adults. MS has an unpredictable clinical course and several clinical patterns. At present, most patients with MS will become increasingly disabled, but data suggest that therapies such as Rebif® may beneficially affect the progression of MS.
Ares-Serono is a leading biotechnology company, headquartered in Geneva Switzerland. The world leader in reproductive health, Ares-Serono is also active in growth/metabolism and multiple sclerosis/immunology. With 1998 sales of US$ 918 million, Ares-Serono operates in 45 countries and its products are sold in over 100 countries. Shares of Ares-Serono S.A. the holding company of the group, are traded on the Swiss stock exchange (ZURICH: AREB).
(a) Biogen, Inc. (BGEN US)
(b) PRISMS Study Group, Randomized Double-Blind Placebo-Controlled Study of Interferon Beta-1a in Relapsing/Remitting Multiple Sclerosis. The Lancet. Vol. 352. Nov 7, 1998. 1498-1504.
(c) The OWIMS (Once-Weekly Interferon for MS) Study Group. Evidence
of Interferon B-1a dose response in relapsing-remitting MS: The OWIMS study.
Neurology 1999; 53:679-686.
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SOURCE: Ares-Serono International S.A.