Schering AG, Germany announced the completion of the first phase of its multiple sclerosis (MS) BEYOND program with the first clinical outcomes of the study -- safety and tolerability data -- at the 19th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Milan. This initial study examined the safety of a new, double-dose of Betaferon in relapsing-remitting MS patients. The results showed that both the approved Betaferon dose and the new, higher-dose regimen were safe and well tolerated, and no new or unpredictable side effects were reported.
"These early safety results support the use of a higher dose of Betaferon in the larger patient population to be enrolled in the BEYOND trial," said Dr. Joachim-Friedrich Kapp, Head of Specialized Therapeutics at Schering Group. "Our next step is to determine if a Betaferon dose that is higher than any currently available beta interferon can exert an even greater therapeutic effect, further improving the benefits for patients with relapsing-remitting MS."
In the next stage of the BEYOND program, investigators will compare the relative efficacy of the new, higher-dose Betaferon (500 mcg), Betaferon 250 mcg (the currently approved dose), and glatiramer acetate (Copaxone) in patients with relapsing-remitting MS. BEYOND is a multinational Phase III trial and one of the largest MS studies ever, involving more than 2,000
patients.
Betaferon is marketed in the United States and Canada as Betaseron by Schering's subsidiary, Berlex Laboratories Inc.