![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Transition Begins Enrollment for Multiple Sclerosis Phase II Clinical Trial
Transition Begins Enrollment for Multiple Sclerosis Phase II Clinical Trial
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.
KEYWORDS Drug Pipeline Alert
Upcoming Events
-
11Jul
-
18Jul
-
21Oct