2003-04-04 03:17 ET
Schering AG, Berlin today announced the completion of patient enrollment in the first stage of the BEYOND (Betaferon(R) Efficacy Yielding Outcomes of a New Dose) program. BEYOND will compare safety and efficacy of the standard dose of Betaferon(R), interferon beta-1b (trade name in the US and Canada: Betaseron(R)) for SC Injection -- 250 mcg every other day -- with both a new, higher-dose Betaferon(R) regimen (500 mcg every other day) and glatiramer acetate (Copaxone(R) once daily) in patients with relapsing-remitting multiple sclerosis (RRMS).
At the same time, investigators at the American Academy of Neurology Annual Meeting in Honolulu, Hawaii, USA, presented data that showed higher-than-standard doses of Betaferon(R) are well-tolerated by patients. Neither new or unpredictable side effects were observed in these studies.
"These early safety data support further study of higher Betaferon(R) doses to determine if we can enhance the clinical effect of treatment," said Dr. Joachim-Friedrich Kapp, Head of Specialised Therapeutics at Schering AG. "The BEYOND program will investigate whether a dose higher than any currently available beta interferon can exert even greater therapeutic benefits and is part of Schering's commitment to open new perspectives in treatment for the MS community."
The multinational, Phase III BEYOND study is one of the largest MS trials ever and will be involving more than 2,000 patients. In the second stage of the study, investigators will begin to evaluate the efficacy in addition to the safety and tolerability of the 500 mcg dose of Betaferon(R).
During the AAN meeting, the results of two studies investigating higher-than-standard doses of Betaferon(R) were presented. The one-year OPTimization of Interferon for MS (OPTIMS) study examined relapsing-remitting MS patients on Betaferon(R) 250 mcg who exhibited persisting signs of disease activity on monthly MRI scans for six months. Patients were randomized to either continue on this regimen or increase their dose to 375 mcg every other day for an additional six months. Monthly MRI scans as well as clinical and laboratory assessments were repeated every three months (or as clinically necessary). Results from the first 74 patients showed that changing to a higher Betaferon(R) dose was not associated with an increase in frequency or severity of side effects.
In the 20-week Interferon Dose Escalation Assessment of Safety (IDEAS) study, 22 patients with a mean baseline Expanded Disability Status Scale (EDSS) score of 3.8 (20 who were receiving Betaferon(R) 250 mcg every other day and two who weren't on a Betaferon(R) regimen) increased their dose to 500 mcg over eight weeks led by a structured dose-escalation program, followed by 12 weeks of maintenance. Results showed that most patients who had tolerated Betaferon(R) 250 mcg also tolerated the 500 mcg dose. The majority of adverse events observed were mild, and included decreased well-being, insomnia and injection site reactions.
Schering AG is a research-based pharmaceutical company. Its activities are focused on four business areas: Gynecology&Andrology, Diagnostics&Radiopharmaceuticals, Dermatology as well as Specialized Therapeutics for disabling diseases in the fields of the central nervous system, oncology and cardiovascular system. As a global player with innovative products Schering AG aims for leading positions in specialized markets worldwide. With in-house R&D and supported by an excellent global network of external partners, Schering AG is securing a promising product pipeline. Using new ideas, Schering AG aims to make a recognized contribution to medical progress and strives to improve the quality of life: making medicine work
This press release has been published by Corporate Communication of Schering AG, Berlin, Germany.
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