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Transition progressing with phase II multiple sclerosis trial

Transition Therapeutics has begun enrolling patients in a phase II clinical trial of its interferon enhancing therapy in patients with multiple sclerosis.

The multiple sclerosis interferon enhancing therapy (MS-IET) combines interferon-b with Transition’s enhancing agent, EMZ701, with the goal of improving outcomes in multiple sclerosis 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.

“With a real medical need for effective MS therapies, this trial is designed to demonstrate the ability of EMZ701 to increase interferon efficacy and recover a large patient population that has lost or is losing responsiveness to current interferon therapies,” said Dr Tony Cruz, Transition’s chairman and CEO.

In a phase I clinical trial, EMZ701 was well tolerated with a good safety profile. In addition, preclinical studies have demonstrated that MS-IET is significantly more effective than interferon-b alone in reducing both symptoms and pathologies associated with MS in multiple animal models.

Transition’s interferon enhancing technologies have also demonstrated more potent anti-viral and anti-proliferative effects than interferon alone and may potentially have applications in hepatitis C, hepatitis B and cancer.