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www.fdanews.com/articles/68212-transition-begins-enrollment-for-multiple-sclerosis-phase-ii-clinical-trial

Transition Begins Enrollment for Multiple Sclerosis Phase II Clinical Trial

February 1, 2005

Transition Therapeutics has begun patient enrollment for a Phase II clinical trial of its Interferon Enhancing Therapy (MS-I.E.T.) in patients with multiple sclerosis (MS).

MS-I.E.T. combines interferon-(B) with Transition's enhancing agent, EMZ701, with the goal of improving outcomes in MS patients without adding toxicity.

The Phase II study will enroll 40 relapsing-remitting MS patients currently on interferon-(B) therapy showing renewed disease activity as evidenced by magnetic resonance imaging (MRI) changes. After monitoring MRI activity for 12 weeks while on interferon-(B) therapy alone, patients will receive weekly EMZ701 treatments in addition to their standard interferon-(B) therapy for 24 weeks.

In a Phase I clinical trial, Transition's EMZ701 was well-tolerated with a good safety profile. In addition, preclinical studies have demonstrated that MS-I.E.T. is significantly more effective than interferon-(B) alone in reducing both symptoms and pathologies associated with MS in multiple animal models.