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| |  AAN: Higher doses of beta interferon effective in slowing multiple sclerosis progression TORONTO, ON -- May 2, 2000 -- Multiple sclerosis patients benefit significantly from higher doses of beta interferon after four years of treatment, according to new data presented today at the 52nd annual meeting of the American Academy of Neurology in San Diego, California. The new long-term results from the PRISMS study provides additional hope for more than one million patients worldwide that are currently living with the continuing threat of disability due to relapsing-remitting multiple sclerosis (RRMS). "These data demonstrate that if patients are treated early with the high-dose interferon beta-1a therapy, Rebif, the progression of the disease can be delayed," according to Mark Freedman, MD, Director of the Multiple Sclerosis Clinic at The Ottawa Hospital-General Campus, and Professor of Medicine (Neurology) at the University of Ottawa, an investigator in the PRISMS trial, who presented the findings. "This is some of the most encouraging information we've ever had about our ability to slow the progression of this disease. The results clearly indicate that beta- interferons can dramatically modify the natural course of the disease over a four-year period, which hopefully translates into an even longer-term benefit." As one of the largest studies ever conducted in patients with MS, the PRISMS study began in 1994 and involved 560 patients at 22 centers in nine countries. Two-year data from the trial was published in 1998 in the British medical journal The Lancet, and was the basis for Rebif'®s market authorization in 50 countries around the world. That data demonstrated that both Rebif 3 x 22 mcg and Rebif 3 x 44 mcg per week significantly reduced the number and severity of relapses, delayed disability progression and reduced disease activity and burden of disease as measured in magnetic resonance imaging (MRI). The new four-year PRISMS data demonstrate that the higher dose is statistically superior to the lower dose. "With the high-dose Rebif, I do everyday things better," said Darlene Martineau, an MS patient diagnosed ten years ago. "I have fewer attacks and I have a normal life like other people." In addition, when evaluating patients at the four-year interval, the new PRISMS data suggest that disease progression was most delayed in patients who started treatment two years earlier in the disease with the higher dose of Rebif (3 x 44 mcg per week), as compared with postponing treatment at lower dose (3 x 22 mcg per week). Also, the study showed that Rebif was similarly well tolerated at high and low doses. The four-year PRISMS data was selected for presentation at the Late- Breaking News session of the AAN, a session highlighting significant news regarding clinical trials in MS. This presentation of the four-year PRISMS data represents the continued interest by neurologists worldwide in the effect of beta interferon, particularly long-term, for patients with relapsing- remitting MS. Additional clinical research is ongoing in a head-to-head study recently launched by Ares-Serono comparing Rebif, the higher-dose interferon beta treatment, with Avonex®, a lower-dose treatment. The trial, which is in the midst of enrolling over 600 patients across the US and worldwide, is the first clinical study to directly compare interferon beta-1a doses across different product formulations. The head-to-head trial compares a 132 mcg weekly subcutaneous dose of Rebif (44 mcg three times per week) to a 30 mcg per week intramuscular dose of Avonex to determine if higher-dose and more frequent administration of interferon beta-1a (Rebif) provides a superior clinical outcome to lower dose, weekly interferon beta-1a (Avonex). Such findings are necessary to meet the U.S. Orphan Drug Act requirements which currently allow market exclusivity for two other interferon beta products, Avonex and Betaseron in the U.S. Rebif is currently not on the market in the U.S. due to the Orphan Drug Law exclusivity for the two other products. 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 onsets mainly in young adult and has lifelong consequences. MS has an unpredictable clinical course and several clinical patterns. At present, most patients with MS will become increasingly disabled over time, but data from trials such as PRISMS suggest that therapies, such as interferon beta, may beneficially affect the progression of relapsing-remitting MS. Ares-Serono, headquartered in Geneva, Switzerland, is a global leader in biotechnology with its U.S. affiliate, Serono Laboratories, Inc., based in Norwell, Massachusetts. In addition to being the world leader in reproductive health with the leading infertility product, Gonal-F, Ares-Serono has strong global market positions in HIV-related metabolism (Serostim) and growth (Saizen). Outside of the U.S., the company markets a high-dose interferon beta-1a product for multiple sclerosis, Rebif. The company's research programs are focused on growing its existing businesses and on establishing new therapeutic areas. In 1999, Ares-Serono achieved worldwide sales of $1.054 billion, of which one-third were generated in North America. The company operates in 45 countries, and its products are sold in over 100 countries. Bearer shares of Ares-Serono S.A., the holding company, are traded on the Swiss SWX stock exchange under the symbol AREB. Related Links: interferon beta-1a (Rebif, Avonex) and Ares-Serono S.A..
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