Clinical utility and pharmacological action of MN-166 in treatment of MS

MediciNova, Inc, a biopharmaceutical company publicly traded on the Nasdaq Global Market (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today reported that this week's issue of Neurology includes two articles related to the potential clinical utility and unique pharmacological action of MN-166 in treating multiple sclerosis (MS).

The primary publication, authored by Frederik Barkhof, M.D., Ph.D., Vrije Universitiet Medical Center, Amsterdam, and collaborators, details the safety and efficacy profile of MN-166 in the two-year MN-166-Cl-001 trial performed in Europe and completed in 2008.  In the article, Dr. Barkhof et al. review ibudilast (MN-166) trial findings, previously summarized in MediciNova's press releases and a presentation at the 2008 WCTRIMS meeting, and poses that ibudilast's apparent clinical benefit may be related to a neuroprotective action. 

Also published was an editorial commentary by the multiple sclerosis specialist, Robert Fox, M.D., Cleveland Clinic, entitled "Primary neuroprotection: The Holy Grail of multiple sclerosis therapy". In this article, Dr. Fox described the challenges of therapeutically impacting the disabling process of neurodegeneration in primary progressive and secondary progressive forms of multiple sclerosis. He then comments on the Barkhof article and notes that ibudilast's unique actions may differentiate it from other approved MS drugs and MS drugs in development. Specifically, he refers to ibudilast's non-selective phosphodiesterase (PDE) inhibition and amelioration of activated resident brain inflammatory cells, known as glial cells, as a possible means of curbing the "smoldering" nature of inflammation in the neurodegeneration associated with progressive MS and potentially other conditions including Parkinson's and Alzheimer's diseases.

Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova noted that "we are pleased that the neurological community is recognizing the potential benefits and unique positioning of MN-166 as a drug therapy in treating disability progression in a serious illness like multiple sclerosis." 

Additionally, Dr. Barkhof, the senior author of the primary Neurology article, wrote that notable efficacy outcomes in the trial such as reduced brain atrophy and conversion of new brain lesions to "persistent black holes," coincident with reduced patient disability progression, suggests that "ibudilast protects neurons in lesions from persistent damage after acute inflammation."  Ibudilast also has been in clinical development by a Avigen, Inc. as a new pharmacological approach for the treatment of chronic neuropathic pain and drug addiction – two other therapeutic indications enabled by ibudilast's unique mechanism of action and pharmaceutical properties. MediciNova acquired Avigen in December, 2009, yielding an integrated ibudilast program with strong preclinical and clinical components, issued and pending use patents and follow-on, patented analogs. Kazuko Matsuda, M.D., Ph.D., Senior Director of Clinical Affairs at MediciNova and a co-author on the MS trial report with Dr. Barkhof, emphasized that "the dose-response relationship between the 30 and 60 mg/day doses in the MN-166-Cl-001 MS trial coupled with the encouraging clinical experience in Avigen's trials at dose regimens up to 100 mg/day provides a strong rationale for continued clinical development of MN-166 in these neurological disorders."