Primary, Secondary Progressive MS Therapy to be Tested in Phase 2 Trial by MediciNova

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by Maureen Newman |

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primary and secondary MS trial

primary and secondary MS trialMediciNova, Inc., recently announced that it had surpassed 50% enrollment for the phase 2b clinical trial evaluating MN-166 (ibudilast) in progressive multiple sclerosis patients. As of September 15th, 150 of an expected 250 patients have enrolled for treatment, and the trial is on track to complete enrollment by the second quarter of 2015.

“We are very pleased to have completed 60% of the enrollment in this study,” said Yuichi Iwaki, MD, PhD, Presiden and CEO of MediciNova, in a news release. “We look forward to providing further updates as the study progresses.”

The study is headed by Robert Fox, MD, MS, FAAN, Vice-Chair for Research if the Neurological Institute of the Cleveland Clinic. NeuroNEXT clinical trial network is conducting the study at 28 academic medical centers, and funding is provided by the National Institutes of Health.

At the heart of the study is MN-166, which has been marketed since 1989 in Japan and Korea to treat bronchial asthma and complications following stroke. It is a first-in-class small molecule drug that is administered orally. It inhibits phosphodiesterase-4 and -10, as well as macrophage migration inhibitory factor, leading to a suppression of inflammation and promotion of neural healing.

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Already, MediciNova established positive results of treatment in a two-year phase 2 clinical trial of patients with relapsing multiple sclerosis. Brain volume loss and new lesions were less likely in patients receiving MN-166 as compared to patients receiving placebo.

This current study will evaluate patients with progressive multiple sclerosis, which has more severe symptoms and poorer outcomes for patients. The trial is known as Secondary and Primary Progressive Ibudilast NeuroNEXT in Multiple Sclerosis (SPRINT-MS) and will evaluate the safety, tolerability, and efficacy of treatment against a placebo. In total, the study is expected to last three years, including time for enrollment, treatment, and data analysis.

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