August 23, 2002
Schering AG ( SHR; SCH), Germany and its U.S. subsidiary Berlex Laboratories, Inc., announced the inclusion of a third treatment group, glatiramer acetate (Copaxone), to its phase III multiple sclerosis (MS) trial, BEYOND (Betaseron Efficacy Yielding Outcomes of a New Dose).
The study - the largest MS trial ever, involving more than 2,000 patients with relapsing-remitting MS - will compare the standard dose of Betaferon/Betaseron (interferon beta-1b) with both glatiramer acetate and a new, even higher-dose Betaferon/Betaseron regimen.
"The MS community is interested in new, comparative data that demonstrates the relative efficacy and safety of different MS drug classes, which may help guide clinical decisions about treatment. The additional study arm makes BEYOND the largest controlled trial to compare a noninterferon, glatiramer acetate, with an interferon," said Stuart D. Cook, MD, president, University of Medicine & Dentistry of New Jersey, and a leading investigator of the study. "Recent American Academy of Neurology guidelines confirm that dose and frequency of administration are key factors to achieving optimal clinical benefit from treatment, the study seeks to advance interferon therapy by exploring whether a dose higher than any currently available interferon can exert a greater therapeutic effect for patients," Cook said
"BEYOND represents our continued commitment to innovation and advancing care for MS patients and neurologists," said Joachim-Friedrich Kapp, head of Specialized Therapeutics at Schering AG. "An abundance of data already has shown that a higher, more frequent dose of interferon has a greater effect on reducing disease activity and disease progression than low-dose interferon regimens.
'The current approved dose of Betaferon/Betaseron has shown unsurpassed efficacy for more than a decade. The expansion of BEYOND to include a glatiramer acetate arm will allow for comparison among an even wider range of dosing regimens across different drug types."
The trial is a worldwide multicenter, randomized, blinded study evaluating the effects of treatment in patients with relapsing-remitting MS. The proposed primary endpoint is the proportion of relapse-free patients during the 2-year period.
Patients will be randomized to one of three arms: Betaferon/Betaseron given every other day as a subcutaneous injection of 500 mcg (16 MIUs), Betaferon/Betaseron 250 mcg (8 MIUs) every other day (the currently approved dosing regimen), or glatiramer acetate given daily as a subcutaneous injection of 20 mg.
Dose titration will take place over a period of several weeks. In keeping with other large-scale clinical trials, an international steering committee comprising renowned MS investigators will be involved.
In addition to BEYOND, Schering has several ongoing studies with Betaferon/Betaseron in potential new indications and new combinations. The company also is developing a number of oral agents to treat MS, and continues to improve upon its successful patient support services.
This article was prepared by Drug Week editors from staff and other
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