Betaferon(R)/Betaseron(R) Demonstrates Treatment Effect in Patients with Primary Progressive Multiple Sclerosis

May Fill Therapeutic Gap for Patients with Rapidly Advancing Form of Disease

BARCELONA, Spain, Sept. 23 /PRNewswire/ -- A new, exploratory phase II study of Betaferon/Betaseron (Interferon beta 1b) in patients with primary progressive multiple sclerosis showed that Betaferon/ Betaseron (Interferon beta 1b) was statistically significantly more efficacious than placebo in reducing multiple sclerosis (MS) lesions as measured by magnetic resonance imaging (MRI). In addition beneficial effects on the progression of the disease were observed. The data -- the first to evaluate Betaferon/Betaseron in this patient population -- were presented at the Late Breaking News Session at the joint ECTRIMS/ACTRIMS meeting held in Baltimore.

Primary progressive MS, which represents approximately 15 percent of all diagnosed MS cases, is characterized by a steady progression of disability with rare instances of remission. Patients have a much less favorable prognosis regarding disability and mortality compared to relapsing remitting (RR) and secondary progressive (SP) multiple sclerosis and had, so far, no therapeutic option.

"Up until now, the primary progressive MS population has received little to no attention in clinical trials of disease-modifying therapies. As a consequence there is currently no available treatment for these patients," said Dr. Xavier Montalban, Unit of Clinical Neuroimmunology at Hospital Universitari Vall d'Hebron (UAB), Barcelona, Spain. "The encouraging data of this study suggest that Betaferon may be a viable treatment for these patients, thus warranting further study in primary progressive MS."

In the double blind, single center study, 73 patients with EDSS scores of 3.0 to 7.0 were randomized to receive either 8 MIU (250 microgram) of Interferon beta 1b or placebo every other day for two years. Ninety-six percent of all patients reached the end of the study. Safety parameters, blood tests and clinical outcomes were performed every three months. MRI measures (e.g. T2 and T1-weighted brain lesion load, active lesions, spinal cord atrophy and spectroscopy) and neuropsychological assessment were undertaken annually. At the end of the study, statistically significant differences were found for T2 (p=0.006) and T1 (p=0.01) lesion load and number of active lesions (p=0.0005) in favor of the Betaferon/Betaseron-treated group. In addition, the proportion of patients with confirmed progression at six months was 22.2 percent in the Betaferon/Betaseron group, compared to 32.4 percent in the placebo group.

Eighty-five percent of symptomatic patients are classified at diagnosis with relapsing-remitting MS. About half of people with relapsing-remitting MS advance into the more debilitating secondary progressive form within ten years. At this stage, after periods of intermittent attacks and remissions, the disease begins a course of steady progression.