SAN DIEGO, March 20, 2013 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the NASDAQ Global Market (Nasdaq:MNOV) and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), today announced that data from a Phase 1b/2a study of MN-166 (ibudilast) in opioid withdrawal and analgesia will be presented during a poster session from 5:30p.m. to 7:00p.m. at the American Academy of Neurology (AAN) Annual Meeting in San Diego on March 21, 2013.
"MN-166 is an intriguing compound that has the potential to help opioid and heroin addicts cease their opioid use with reduced withdrawal symptoms," said Sandra Comer, Ph.D., Professor of Clinical Neurobiology in the Department of Psychiatry at the College of Physicians and Surgeons of Columbia University, Research Scientist at the New York State Psychiatric Institute and principal investigator of the study. "The preliminary safety and efficacy data generated by this clinical trial provided the necessary information to launch the NIDA-funded Phase 2a clinical trial of MN-166 in prescription opioid or heroin abusers that is currently underway. We are excited to be a part of this critical research that may provide new options for these patients."
Dr. Comer will present "A Drug Candidate for Improving Opioid Analgesia and Attenuating Dependence and Tolerance: An Exploratory Trial of Ibudilast in Morphine Withdrawal and Analgesia in Heroin Addicts" on March 21 at the AAN. Preliminary data analyses from this study were presented in 2011 at the College on Problems of Drug Dependence meeting and the current presentation includes final data analyses.
According to the Substance Abuse and Mental Health Services Administration's (SAMHSA) 2011 National Survey on Drug Use and Health, there are approximately 1.4 million people with nonmedical pain reliever dependence and approximately 369,000 people with heroin dependence in the U.S. The economic costs of nonmedical use of prescription opioids in the U.S. was estimated at $53.4 billion in 2006, according to a study published in The Clinical Journal of Pain (Hansen RN et al., 2011 Mar-Apr; 27(3):194-202). Most of the medications currently approved by the FDA for the treatment of opioid dependence are opioid agonists that carry the risk of secondary dependence or abuse and have opioid-related safety risks.
In this clinical study, heroin addicts were randomized into separate treatment groups of placebo, 40 mg/day MN-166 or 80 mg/day MN-166. Safety and tolerability and preliminary efficacy were major analyzed outcomes. Dose-related ibudilast efficacy was also observed in the study. For example, physical withdrawal symptoms were significantly reduced (p≤0.05) by MN-166 treatment as measured by the Subjective Opioid Withdrawal Scale (SOWS) and oxycodone-mediated analgesia (McGill pain questionnaire) was significantly enhanced (p≤0.05) by 80 mg/day ibudilast compared to placebo. Moreover, opioid-related pupil constriction was greater in the 80 mg/day ibudilast group compared to the placebo group (p≤0.05) suggesting lessened tolerance development. Ibudilast was safe and well-tolerated in the study with no serious adverse events, no discontinuations due to treatment and no impact on opioid respiratory changes compared to placebo.
"We are pleased with the outcome of this study and excited that it was selected for presentation at AAN," commented Dr. Yuichi Iwaki, President and CEO of MediciNova. "We look forward to the next milestone in this indication which will be completion of the ongoing Phase 2a clinical trial of MN-166 in subjects addicted to prescription opioids or heroin."
About the Study
The trial was led by Sandra Comer, Ph.D., Professor of Clinical Neurobiology, and additional drug addiction researchers, including Ziva Cooper, Ph.D., Assistant Professor of Clinical Neurobiology at Columbia. The 21-day, inpatient, double-blind, placebo-controlled study enrolled 30 non-treatment-seeking, heroin-dependent volunteers who were maintained on oral morphine for the first 14 days. In the first week, all subjects received placebo and on day 8, participants were randomized to continue placebo (P), low dose (L; 20 mg twice daily (40 mg/day)) ibudilast, or high dose (H; 40 mg twice daily (80 mg/day)) ibudilast. Data were analyzed from 10 subjects completing each treatment arm. In the third week, morphine was no longer administered so that withdrawal phenomena during detoxification could be monitored.
Primary endpoints were safety/tolerability and changes in total subjective opioid withdrawal scale (SOWS) score. Secondary endpoints included other withdrawal scales and analgesia and physiological measurements. Indicators of altered analgesia or tolerance (reduced opioid effects with repeat morphine exposure) were assessed in laboratory sessions with oxycodone administration and cold water immersion of the hand followed by objective and subjective pain endpoints.
About MN-166 Clinical Development in Addiction
Clinical development of MN-166 is ongoing in both methamphetamine addiction and opioid addiction. These clinical trials are conducted by some of the country's leading experts in opioid and methamphetamine addiction. A Phase 1b clinical trial of MN-166 in methamphetamine dependence is near completion at UCLA. A Phase 2 outpatient clinical trial of MN-166 in methamphetamine dependence, led by investigators at UCLA, has been funded by NIDA. In opioid addiction, a second NIDA-funded clinical trial of MN-166 in prescription opioid or heroin abusers is currently ongoing with the investigators at Columbia University and the New York State Psychiatric Institute. This ongoing Phase 2a trial involves in-unit treatment for six weeks with either placebo or 100 mg/day MN-166 and is tailored to confirm some prior endpoints and to assess the effect of MN-166 on opioid craving and self-administration behavior.
About MN-166 (ibudilast)
MN-166 has been marketed in Japan and Korea since 1989 to treat cerebrovascular disorders, including post-stroke complications, and bronchial asthma. MediciNova licensed MN-166 (ibudilast), from Kyorin Pharmaceutical in October 2004 for potential utility in relapsing remitting multiple sclerosis. MediciNova scientists and collaborators independently established evidence of ibudilast utility in opioid and methamphetamine addiction as well as chronic neuropathic pain.
MN-166 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 including IL-1ß, TNF-a, and IL-6, and may upregulate the anti-inflammatory cytokine IL-10 and neurotrophic factors. It attenuates the activation of brain glial cells in neurological disorders and that cellular action is thought to contribute to its therapeutic action. Accordingly, MediciNova's development efforts in progressive MS and chronic neuropathic pain are founded upon both anti-neuroinflammatory and neuroprotective actions which have been demonstrated in preclinical and clinical data.
MediciNova's method-of-use patent for MN-166 for the treatment of addiction expires no earlier than 2030 in the U.S. In the approved and pending grant-funded MN-166 trials, one of MediciNova's commitments is to provide delayed-release ibudilast final product. A drug supply collaboration with Taisho Pharmaceutical Industries, Ltd., owned by Teva Pharmaceuticals, has expanded to include development of higher dosage strength ibudilast capsules.
MediciNova, Inc. is a publicly traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet need with a commercial focus on the U.S. market. MediciNova's current strategy is to focus on its two prioritized product candidates, MN-166 (ibudilast) for neurological disorders, and MN-221 for the treatment of acute exacerbations of asthma. MN-166 is being developed in Phase 1 and Phase 2 clinical trials for drug dependence and pain, largely through investigator sponsored trials and outside funding. Proceeding with proof-of-concept Phase 2b trial(s) in Progressive MS is dependent on receipt of funding, which we are pursuing. MediciNova is engaged in strategic partnering and consortium funding discussions to support further development of both the MN-221 and ibudilast/MN-166 programs. 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 our clinical development strategies, including future development, statements regarding the progress of clinical trials, statements regarding expectations for the ibudilast/MN-166 program, including development of ibudilast/MN-166 for certain indications and expectations on future progress in the development of our drug candidates, expected timing of clinical trial results and any implication as to the results of our development, partnering and funding efforts, the implication of patent terms and potential product exclusivity and the implication that the company will have the ability to execute on its priorities. 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, risks of obtaining future partner or grant funding for development of 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 obtained 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, 2011 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.
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