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MediciNova Announces New NIDA Grant for MN-166 (ibudilast) in Opioid Dependence

LA JOLLA, Calif., Sept. 7, 2014 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that Columbia University and the New York State Psychiatric Institute was awarded new grant funding from the National Institute on Drug Abuse (NIDA) to continue clinical research on MN-166 (ibudilast) in opioid dependence. The new grant will support the completion of a Phase 2a clinical trial of MN-166 (ibudilast) in opioid dependence, for which positive interim results were previously reported by MediciNova on August 18, 2014.

The principal investigator, Dr. Sandra Comer, PhD, Professor of Neurobiology at Columbia University and the New York State Psychiatric Institute commented, "We are honored to receive this grant from NIDA with more than $2.66 MM for the next nine months and to be notified of a potential award of more than $11 MM for the next four years."

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased with NIDA's continued support of clinical research on MN-166 (ibudilast) in opioid dependence. We look forward to additional data as the study advances."

About the Trial

The study is a randomized, placebo-controlled, double-blind, inpatient Phase 2a study of MN-166 (ibudilast) in opioid-dependent abusers of prescription opioids and/or heroin. The study duration is approximately 6 weeks per subject. The crossover study design includes initial detoxification followed by randomization to ibudilast 50 mg BID or placebo. Subjects are maintained on each dose for at least two to three consecutive weeks (one week stabilization + one and a half weeks testing). During test weeks, participants receive oxycodone (0, 15, or 30 mg PO) in random order on separate days. For each dose, a sample followed by a choice session is completed. During the choice session, a "drug versus money" self-administration paradigm is employed. The primary aim of the study is to investigate the ability of MN-166 to alter the reinforcing, analgesic, subjective, performance, and physiological effects of oxycodone, a commonly abused prescription opioid.

About MN-166 (ibudilast)

MN-166 (ibudilast) has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova licensed MN-166 (ibudilast) from Kyorin Pharmaceutical for potential utility in relapse-remitting multiple sclerosis (RRMS). Intellectual property was additionally established or obtained by MediciNova in progressive MS and other neurological conditions. MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) -4 and 10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. It attenuates the activated glia cells, which play a major role in certain neurological conditions. Ibudilast's anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical study results and provide the rationale for its therapeutic utility in neurodegenerative diseases (e.g., progressive MS and Amyotrophic Lateral Sclerosis [ALS]), substance abuse/addiction and chronic neuropathic pain.

About MediciNova

MediciNova, Inc. is a publicly-traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs with a commercial focus on the U.S. market. MediciNova's current strategy is to focus on MN-166 (ibudilast) for neurological disorders such as progressive MS, ALS, and substance dependence (e.g., Methamphetamine dependence, opioid dependence) and MN-001 (tipelukast) for nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF) and other fibrotic disease. MediciNova's pipeline also includes MN-221 (bedoradrine) for the treatment of acute exacerbations of asthma and MN-029 (denibulin) for solid tumor cancers. MediciNova is engaged in strategic partnering and other potential funding discussions to support further development of its programs. For more information on MediciNova, Inc., please visit www.medicinova.com.

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 the future development and efficacy of MN-166, MN-221 and MN-001. 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," "considering," "planning" 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, risks of obtaining future partner or grant funding for development of MN-166, MN-221 and MN-166 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, 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, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, 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 of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, 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, 2013 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.

CONTACT: INVESTOR CONTACT: Geoff O'Brien Vice President MediciNova, Inc. info@medicinova.com

Source:MediciNova, Inc.