June 24, 2002
Dow Jones Newswires; 201-938-5388
NEW YORK -- Schering AG (SHR) and its U.S. unit, Berlex Laborabories, added glatiramer acetate as a third treatment group in its Phase III multiple sclerosis trial.
In a press release Monday, the pharmaceutical company said the expanded study will compare the standard dose of Betaferon/Betaseron with glatiramer acetate and a new, higher-dose Betaferon/Betaseron regimen.
The Betaseron Efficacy Yielding Outcomes of a New Dose, or BEYOND, trial involves more than 2,000 patients with relapsing-remitting MS, as the company reported in April.
The trial is a worldwide multi-center, randomized, blinded study evaluating the effects of treatment in patients with relapsing-remitting MS.
Patients will be randomized into one of three arms: Betaferon/Betaseron given every other day as a subcutaneous injection of 500 mcg, Betaferon/Betaseron 250 mcg every other day (the currently approved dosing regimen), or glatiramer acetate given daily as a subcutaneous injection of 20 mg.
"An abundance of data already have 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 company said
in the release. "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."
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