MediciNova, Inc. (MNOV)

[someconcerns]

Update on MN-166 progress:

http://finance.yahoo.com/news/medicinova-provides-phase-2b-trial-230000740.html

MediciNova Provides Update on Phase 2b Trial of MN-166 (ibudilast) in Progressive MS
MediciNova, Inc. 2 hours ago GlobeNewswire

LA JOLLA, Calif., Sept. 23, 2014 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that, as of September 15, 2014, the ongoing Phase 2b trial of MN-166 (ibudilast) in progressive multiple sclerosis (MS) had enrolled 150 of the 250 subjects planned to be enrolled. Enrollment is expected to be completed during the first quarter of 2015.

The study is being funded by the U.S. National Institutes of Health (NIH) and is being conducted by the NeuroNEXT clinical trial network within the National Institute of Neurological Disorders and Stroke (NINDS) at the NIH. The collaboration to perform the study includes 28 academic medical centers, MediciNova and advocacy support from the National Multiple Sclerosis Society. The principal investigator is Robert Fox, M.D., M.S., FAAN, Vice-Chair for Research, Neurological Institute, Cleveland Clinic.

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased to have completed 60% of the enrollment in this study. We look forward to providing further updates as the study progresses."

About the Progressive MS Trial

The Phase 2 Secondary and Primary Progressive Ibudilast NeuroNEXT trial in Multiple Sclerosis (SPRINT-MS) involves 28 enrolling clinical sites across the U.S. and is designed to evaluate the safety, tolerability and efficacy of MN-166 (ibudilast) administered twice daily to subjects with primary or secondary progressive multiple sclerosis (PPMS or SPMS, respectively). 250 qualifying subjects will be randomly assigned 1:1 to inactive control (placebo) or MN-166 (ibudilast) administered at a dose of 100 mg/day (i.e., 50 mg twice daily). The progressive MS subjects may be either untreated with long-term disease modifying therapy (DMT) or may continue either glatiramer acetate (GA) or interferon beta (IFNß-1a or IFNß-1b) treatment. Hence, randomization will be controlled (stratified) by two factors: therapy status (IFN/GA vs. no DMT) and disease status (PPMS vs. SPMS). The primary objectives of the study are 1) to evaluate the activity of ibudilast (MN-166) versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF), and 2) to evaluate the safety and tolerability of ibudilast (MN-166) (100 mg/day) versus placebo administered orally in subjects with primary or secondary progressive multiple sclerosis. Secondary measures include disability, imaging analyses of brain and retinal tissue integrity, cortical atrophy, cognitive impairment, quality-of-life, and neuropathic pain. Exploratory objectives include pharmacokinetic and biomarker analyses.

About the Cooperative Effort

The collaborating entities include NeuroNEXT, the Cleveland Clinic, the National MS Society and MediciNova. NINDS's Network for Excellence in Neuroscience Clinical Trials, or NeuroNEXT, was created to conduct studies of treatments for neurological diseases through partnerships with academia, private foundations, and industry. NeuroNEXT sites include many of the leading medical centers in the U.S. The goals of NeuroNEXT include testing of promising neurological therapies in Phase 2 clinical trials, optimizing drug development time and cost components through an established clinical trials infrastructure, and the coordination of public/private sector efforts by leveraging NINDS' existing relationships with academic investigators and patient advocacy groups. A clinical coordinating center for the network is based at Massachusetts General Hospital and the data coordinating center is at University of Iowa. Dr. Fox and colleagues at the Cleveland Clinic collaborate with co-investigators at academic medical centers in the NeuroNEXT network. The National MS Society is providing patient advocate input and trial enrollment awareness. MediciNova holds the trial IND with the FDA Division of Neurology Products and additionally provides scientific and analytical support and drug and placebo supply.

About Progressive Multiple Sclerosis

According to the National MS Society, MS affects approximately 2.1 million people worldwide. Approximately 85% of MS patients are initially diagnosed with relapsing remitting MS (RRMS). Approximately 50% of RRMS patients transition into secondary progressive MS (SPMS) in which there are fewer or no relapses but gradual worsening of health. Approximately 10% of MS patients are diagnosed with primary progressive MS (PPMS) at onset and exhibit increasing disabilities in walking, vision, mental acuity, and other bodily functions that are typical in both PPMS and SPMS without ever experiencing relapses or remissions. Current therapies for multiple sclerosis (MS) affect the inflammatory response, but provide limited benefit for neurodegeneration and/or brain tissue repair. There is an unmet need for agents which may provide neuroprotection. A National MS Society multi-disciplinary focus group has described some of the key features of each type of MS as follows: