SAN DIEGO, June 18, 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 the presentation of preliminary results from a Phase 1b study of MN-166 (ibudilast) in methamphetamine addiction at the 75th Annual Meeting of the College on Problems of Drug Dependence (CPDD) in San Diego on June 18, 2013. MN-166 was featured in both a poster session and a symposium at the meeting where leading researchers discussed the role of activated glia, and potential intervention with glial attenuators like MN-166, in drug abuse. Pre-clinical and early clinical results were summarized in the symposium session.
"We are excited to present the results of our initial analyses of data from our trial showing MN-166 does not cause significant changes in cardiovascular functioning in the presence of relevant doses of methamphetamine in people living with methamphetamine addiction. We are additionally encouraged with the discussion at the symposium of the strong potential for glial attenuators, like MN-166, to provide a novel approach to fighting drug addictions," said Steven Shoptaw, Ph.D., Professor, UCLA Departments of Family Medicine and Psychiatry and Biobehavioral Sciences and principle investigator of the trial. "Methamphetamine is toxic to the brain. MN-166 may act by reducing methamphetamine's neurotoxic inflammation and attenuating other actions contributing to dependence."
"MN-166 is a novel and exciting approach to treating drug addiction," said co-investigator Keith Heinzerling, M.D., Assistant Professor, UCLA Department of Family Medicine, Medical Director, UCLA Center for Behavioral and Addiction Medicine. "We look forward to initiating later this summer a National Institute on Drug Abuse-funded Phase 2 trial of MN-166 for methamphetamine dependence."
Preliminary results from one cognitive performance task, presented in a poster session, showed significant improvement in measures of sustained attention in subjects completing a treatment sequence ending with a one-week course of MN-166 dosing at 100 mg/day versus those subjects completing the treatment sequence on an inactive control ("placebo"). In addition, MN-166 was featured in a symposium panel titled "Preclinical to Clinical Evidence that Glia and Neuroinflammation Mediate Drug Abuse and Related Pathologies on Tuesday, June 18 at 10:00 am Pacific. The panel included researchers from UCLA, Columbia University in New York, and Virginia Commonwealth University. In the symposium, Dr. Shoptaw summarized results of cardiovascular safety analyses wherein infusions of methamphetamine administered at placebo, 40 mg/day and 100 mg/day MN-166 regimens. Analyses showed that in the presence of relevant doses of methamphetamine, MN-166 produced no significant changes in blood pressure or heart rate. These cardiovascular safety interaction endpoints were a primary objective in the study design. He also noted that MN-166 administration did not result in any serious or severe adverse events, or subject discontinuations due to adverse events. These findings provide support for moving forward with the Phase 2 trial.
"We are very pleased with the continuing safety data for MN-166 and look forward to advancing our program, focusing on drug addiction indications as well as progressive multiple sclerosis," said Dr. Yuichi Iwaki, President and CEO of MediciNova. "Congratulations to Drs. Shoptaw and Heinzerling on their unwavering efforts to test pharmacotherapies for this devastating disease."
About Methamphetamine Addiction
Methamphetamine is a very addictive stimulant that is closely related to amphetamine. It is long lasting and toxic to dopamine nerve terminals in the central nervous system. It is a white, odorless, bitter-tasting powder taken orally or by snorting or injecting, or a rock "crystal" that is heated and smoked.
Methamphetamine increases wakefulness and physical activity, produces rapid heart rate, irregular heartbeat, and increased blood pressure and body temperature. Long-term use can lead to memory loss, aggression, psychotic behavior, heart damage, malnutrition and severe dental problems. All users, but particularly those who inject the drug, risk infectious diseases such as HIV/AIDS and hepatitis.
According to the Substance Abuse and Mental Health Services Administration's (SAMHSA) 2011 National Survey on Drug Use and Health, there are approximately 439,000 methamphetamine abusers in the U.S. An independent study conducted by the Rand Corporation estimated the economic burden of methamphetamine use in the U.S. at $23.4 billion in 2005. There are no medications currently approved by the FDA for the treatment of methamphetamine dependence. Herbert D. Kleber M.D., founder and Director of the Division on Substance Abuse, New York State Psychiatric Institute, and Professor of Psychiatry at Columbia University Medical Center, and a prior Deputy Director at the White House Office of National Drug Control Policy noted that "there truly is an unmet need for pharmacotherapy treatment of methamphetamine dependence and the recognition of such need by the FDA is positive for the field."
About MN-166 Clinical Development in Addiction
Clinical development of MN-166 is ongoing in both methamphetamine addiction and opioid addiction. Potential utility in alcohol dependence is also under consideration. The ongoing or pending clinical trials are conducted by some of the country's leading experts in studying treatments for these drugs of abuse. 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 Phase 2a 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.
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. Potential utility in progressive multiple sclerosis arose from certain outcomes of a phase 2 trial reported in 2010.
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 like GDNF and NGF. It attenuates the activation of brain glial cells in neurological disorders and that cellular effect 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 issued method-of-use patent for MN-166 for the treatment of addiction expires no earlier than 2030 in the U.S. In the ongoing 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 multiple indications, largely through investigator sponsored trials and outside funding. Proof-of-concept Phase 2b trial(s) in Progressive MS are pending. MediciNova is engaged in strategic partnering and consortium funding discussions to support further development of both the MN-221 and MN-166 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 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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