Novel Approach With Copaxone Shows Dramatic Improvements in MS

Results from an independent retrospective evaluation of a novel treatment protocol with Copaxone demonstrated long-term suppression of clinical and magnetic resonance imaging (MRI) activity in patients with very aggressive relapsing-remitting multiple sclerosis (RRMS).

Copaxone (glatiramer acetate injection) was given in an open-label manner as sequential combination therapy with mitoxantrone (MX), then continued as monotherapy for up to five years. This combination stabilized or improved disability, significantly suppressed relapses, and exhibited no MRI evidence of new brain lesions.

Recognizing the potential impact of this unique therapeutic approach in more aggressive forms of RRMS, Teva Neuroscience completed enrollment of 40 patients in December 2004 for a multicenter North American study designed to evaluate the safety of this combination and confirm these dramatic results. Twenty-seven patients with early active RRMS were included in the independent study. Following induction therapy with MX alone, Copaxone was given in sequential combination with MX for three to seven months. The sequential combination dosing was standardized to five months for the final 17 patients entered, representing one or two pulses of MX. Patients then continued on long-term Copaxone monotherapy. While on MX alone, six relapses occurred. Only two relapses occurred, four and 12 months, after initiation of Copaxone.