Phase 2a Trial With Ibudilast Funded by the National Institute of Drug Abuse (NIDA)
SAN DIEGO, Nov. 20, 2012 (GLOBE NEWSWIRE) -- MediciNova, Inc. a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), announced the initiation of enrollment of a Phase 2a clinical trial with MN-166 (ibudilast) in prescription opioid or heroin abusers. The trial will be conducted at Columbia University and the New York State Psychiatric Institute and is funded by the National Institutes for Drug Abuse (NIDA), part of the National Institutes of Health.
"We are excited to expand our investigation of MN-166 to include prescription opioids such as OxyContin and Vicodin, which will increase the number of people who would qualify for this trial," said Sandra Comer, Ph.D., Professor of Clinical Neurobiology with joint appointments at Columbia University and the New York State Psychiatric Institute and primary investigator of the trial. "We have seen positive signals with MN-166 in our earlier Phase 1b work in heroin addiction and look forward to pursuing this unique therapeutic approach for opioid addiction, a very complex and difficult health condition that can affect anyone and often requires long-term treatment and care."
The MN-166 Phase 2a trial signifies the next step in the development of MN-166 and is the second of a strategic set of trials assessing the potential for MN-166 in opioid abuse and withdrawal. MN-166 is also in a Phase 2 trial for methamphetamine addiction at UCLA and will soon begin a separate Phase 2 trial for patients with multiple sclerosis.
"We believe the initiation of this Phase 2a opioid dependence trial is the next logical step in the development for MN-166 and builds upon the momentum created through our clinical program for MN-166 in drug addiction and other neurological disorders," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. "MN-166 is a very unique therapeutic that may have the potential to help patients with debilitating disorders who have little to no other options. We are committed to strategically moving forward our broad-scale program for this important therapy."
About the Trial
The NIDA-supported trial will enroll 24 healthy abusers of prescription opioids (including OxyContin, Vicodin, Percocet) or heroin. The goal of the trial is to assess MN-166's ability to not only reduce withdrawal symptoms following opioid detoxification, but to reduce the tendency to self-administer oxycodone, a frequently prescribed and abused opioid, and improve the acute pain relief action of oxycodone. The clinical trial subjects will complete two 20-day periods in a clinical research unit wherein they are detoxified and randomized to placebo or 100mg/day ibudilast (MN-166).
MN-166 is a first-in-class, orally bioavailable small molecule glial attenuator. It suppresses pro-inflammatory cytokines IL-1 beta, TNF alpha, and IL-6, and may upregulate the anti-inflammatory cytokine IL-10 and neurotrophic factors like GDNF. While considered a New Molecular Entity (NME) in the United States and Europe, the therapy was first approved in Japan more than 15 years ago. The drug has been prescribed in Japan to over one million patients for asthma and post-stroke complications.
MN-166 acts on glial cells, which outnumber neurons by nearly 10 to 1. Most current therapies for opioid addiction involve the administration of compounds that bind to the same neuronal receptors as the opioids, including opioid antagonists that block the action of opioids throughout the brain and nervous system. MN-166's unique mechanism of action involves attenuation of glial cell activation. Research has shown that opioids not only affect neurons but also activate glial cells. Glial cell activation is gaining increasing appreciation as a contributing factor in abuse of opioids and methamphetamine. Accordingly, MN-166 is additionally being developed for methamphetamine dependence. A Phase 1b safety interaction trial is nearing completion at UCLA and, as recently reported, a NIDA-supported Phase 2 outpatient trial at UCLA is expected to begin enrollment early next year.
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. 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 coverage 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 ibudilast (MN-166) for neurological disorders. MN-221 is involved in clinical trials under U.S. INDs. MN-166 is being developed in Phase 1b/2 trials for pain and drug addiction, largely through Investigator INDs 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 ibudilast/MN-166 programs. Additionally, MediciNova will seek to monetize opportunistically its other pipeline 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 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 or 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 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 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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