Positive Response and Safety Profile of NOVANTRONE Confirmed over a Three Year Period In Study Treating People with Secondary Progressive Multiple Sclerosis
TORONTO, ONTARIO, CANADA - Patients with secondary progressive multiple sclerosis (MS) treated with NOVANTRONER (mitoxantrone for injection concentrate) experienced sustained reduction in their number of attacks, and delay in their disability progression, compared to patients treated with placebo. The new results, involving patients treated for two years and then followed for an additional year, were presented today by researchers at the 51st Annual Meeting of the American Academy of Neurology (AAN).
These findings follow the previously announced two year study results, which were reported at the September 1998 Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). This Phase III, multicenter, placebo-controlled, randomized, observer-blind study of 194 patients with secondary progressive MS assessed the effects of NOVANTRONE on attacks and disease progression. In this study, patients taking NOVANTRONE had fewer attacks and less deterioration of their neurologic impairment. These clinical data were corroborated by positive magnetic resonance imaging (MRI) data.
The study compared two doses of NOVANTRONE -- 12 mg/m2 and 5 mg/m2 - with placebo. Each treatment was administered by short, IV infusion once every three months for two years. Other treatments currently approved for the relapsing-remitting form of MS require a subcutaneous or intramuscular self-injection on a daily or weekly basis.
"Today's third-year follow-up data presentation confirms the earlier findings of this Phase III study," said Peggy V. Phillips, senior vice president, pharmaceutical development for Immunex. "The next step is to file data with the FDA to seek an expanded label for the use of NOVANTRONE in MS."