SAN DIEGO, April 1, 2010 (GLOBE NEWSWIRE) -- 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."
About MediciNova
MediciNova, Inc. is a publicly-traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of serious diseases with a commercial focus on the U.S. market. Through strategic alliances primarily with Japanese pharmaceutical companies, MediciNova holds rights to a diversified portfolio of clinical and preclinical product candidates, each of which MediciNova believes has a well-characterized and differentiated therapeutic profile, attractive commercial potential and patent assets having claims of commercially adequate scope. MediciNova's pipeline includes six clinical-stage compounds for the treatment of acute exacerbations of asthma, chronic obstructive pulmonary disease exacerbations, multiple sclerosis and other neurologic conditions, asthma, interstitial cystitis, solid tumor cancers, Generalized Anxiety Disorder, preterm labor and urinary incontinence and two preclinical-stage compounds for the treatment of thrombotic disorders. MediciNova's current strategy is to focus on its two prioritized product candidates, MN-221 for the treatment of acute exacerbations of asthma and chronic obstructive pulmonary disease exacerbations and MN-166/AV-411 for the treatment of multiple sclerosis or chronic pain or drug addiction. Each drug candidate is currently in clinical trial under U.S. INDs and MediciNova is considering strategic collaborations to support further development of the MN-221 and MN-166/AV-411 programs. Additionally, MediciNova will seek to monetize its other product candidates. For more information on MediciNova, Inc., please visit www.medicinova.com.
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Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding MediciNova's clinical trials supporting safety and efficacy of product candidates and the potential novelty of such product candidates as treatments for disease, plans and objectives for present and future clinical trials and product development, strategies, future performance, expectations, assumptions, financial condition, liquidity and capital resources. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements, include, but are not limited to, the risks and uncertainties inherent in clinical trials and product development and commercialization, such as the uncertainty in results of clinical trials for product candidates, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials and the timing, cost and design of future clinical trials and research activities, the timing of expected filings with the FDA, MediciNova's failure to execute strategic plans or strategies successfully, MediciNova's collaborations with third parties, MediciNova's ability to realize the anticipated strategic and financial benefits from its acquisition of Avigen, Inc., to integrate the two ibudilast development programs and to pursue discussions with potential partners to secure a strategic collaboration to advance the clinical development of the combined development program, the availability of funds to complete product development plans and MediciNova's ability to raise sufficient capital when needed, intellectual property or contract rights, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2009 and its subsequent periodic reports on Forms 10-Q and 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.