SAN DIEGO, July 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 Tokyo Stock Exchange (Code Number: 4875), today announced the funding and regulatory approvals of a NIH-based grant for a Phase 2b trial of MN-166 (ibudilast) in subjects with progressive multiple sclerosis (progressive MS). The principal investigator will be Robert Fox, M.D., M.S., FAAN, Staff Neurologist at the Mellen Center for Multiple Sclerosis at Cleveland Clinic.
The grant is for a funded cooperative effort by the NeuroNEXT clinical trial network within the National Institute of Neurological Disorders and Stroke (NINDS) at the U.S. National Institutes of Health (NIH). The collaboration additionally includes multiple academic centers, MediciNova and advocacy support from the National Multiple Sclerosis Society.
"MS is the leading cause of non-traumatic neurologic disability in young adults and there are no approved therapies to alter the long-term course of this disease," noted Dr. Robert Fox, who has no financial relationship with MediciNova. He further added that "this will be a very important trial in the U.S. as we will have an opportunity to both evaluate the safety and efficacy of a potential neuroprotective therapy and to advance the development of clinical tools for studying neurodegenerative disorders."
Dr. Fox became intrigued with the potential for MN-166 (ibudilast) as a peer-review expert of the summary data from MediciNova's Eastern European trial in relapsing multiple sclerosis wherein neuroprotective activity was indicated (1, 2). He and MediciNova leaders recognized that ibudilast may be best positioned for utility as a new treatment for progressive multiple sclerosis (MS) and, together, began exploring a grant option with the NINDS' NeuroNEXT Phase 2 clinical trial network. Dr. Fox concluded that "we are very pleased to have successfully completed the requisite NIH and FDA review phases and look forward to initiating patient enrollment this fall."
"There is a significant, unmet need for treatments that can benefit people with progressive forms of MS," says Timothy Coetzee, PhD, Chief Research Officer of the National MS Society. "This clinical trial of ibudilast will provide important information on a potential way to stop MS damage, as well as how to measure treatment benefits, and aligns well with the Society's research agenda for stopping MS progression."
"We are pleased with the selection of MN-166 for this NeuroNEXT trial and the opportunity to advance its development in progressive MS.," said Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, Inc. "The safety and efficacy data derived from this trial will add to our overall development efforts and will complement efforts underway for Phase 2 trials of MN-166 in methamphetamine addiction and opioid addiction in the U.S."
About the Trial
The Phase 2 Secondary and Primary Progressive Ibudilast NeuroNEXT trial in Multiple Sclerosis (SPRINT-MS) involves 28 enrolling clinical sites across the U.S. and is designed to evaluate the safety, tolerability and efficacy of MN-166 (ibudilast) administered twice daily to subjects with primary or secondary progressive multiple sclerosis (PPMS or SPMS, respectively). 250 qualifying subjects will be randomly assigned 1:1 to inactive control (placebo) or MN-166 (ibudilast) administered at a dose of 100 mg/day (i.e. 50 mg twice daily). The progressive MS subjects may be either untreated with long-term disease modifying therapy (DMT) or may continue either glatiramer acetate (GA) or interferon beta (IFNβ-1a or IFNβ-1b) treatment. Hence, randomization will be controlled (stratified) by two factors: therapy status (IFN/GA vs. no DMT) and disease status (PPMS vs. SPMS). The primary objectives of the study are: 1) to evaluate the activity of ibudilast (MN-166) versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF), and 2) to evaluate the safety and tolerability of ibudilast (MN-166) (100 mg/day) versus placebo administered orally in subjects with primary or secondary progressive multiple sclerosis. Secondary measures include imaging analyses of brain and retinal tissue integrity, cortical atrophy, disability, cognitive impairment, quality-of-life, and neuropathic pain. Exploratory objectives include pharmacokinetic and biomarker analyses. The trial is expected to require approximately three years for enrollment, treatment, and data analyses.
About the Cooperative Effort
The collaborating entities include NeuroNEXT, the Cleveland Clinic, the National MS Society and MediciNova. NINDS's Network for Excellence in Neuroscience Clinical Trials, or NeuroNEXT, was created to conduct studies of treatments for neurological diseases through partnerships with academia, private foundations, and industry. NeuroNEXT sites include many of the leading medical centers in the U.S. The goals of NeuroNEXT include testing of promising neurological therapies in Phase 2 clinical trials, optimizing drug development time and cost components through an established clinical trials infrastructure, and the coordination of public/private sector efforts by leveraging NINDS' existing relationships with academic investigators and patient advocacy groups. A clinical coordinating center for the network is based at Massachusetts General Hospital and the data coordinating center is at University of Iowa. Dr. Fox and colleagues at the Cleveland Clinic will collaborate with co-investigators at over 20 additional academic medical centers in the NeuroNEXT network. The National MS Society is providing patient advocate input and trial enrollment awareness. MediciNova holds the trial IND with the FDA Division of Neurology Products and additionally provides scientific and analytical support and drug and placebo supply.
About Progressive Multiple Sclerosis
According to the National MS Society, MS affects approximately 2.1 million people worldwide. Approximately 85% of MS patients are initially diagnosed with relapsing remitting MS (RRMS). Approximately 50% of RRMS patients transition into secondary progressive MS (SPMS) in which there are fewer or no relapses but gradual worsening of health. Approximately 10% of MS patients are diagnosed with primary progressive MS (PPMS) at onset and exhibit increasing disabilities in walking, vision, mental acuity, and other bodily functions that are typical in both PPMS and SPMS, without ever experiencing relapses or remissions. Current therapies for multiple sclerosis (MS) affect the inflammatory response, but provide limited benefit for neurodegeneration and/or brain tissue repair. There is an unmet need for agents which may provide neuroprotection. A National MS Society multi-disciplinary focus group has described some of the key features of each type of MS as follows:
| Primary-Progressive MS | Secondary-Progressive MS |
| Younger at onset of progression | Older at onset of progression |
| More likely in men | More likely in women |
| Generally takes longer to diagnose than relapsing MS | Diagnosed well after transition from relapsing MS to SPMS has already occurred |
About MN-166 Clinical Development
Clinical development of MN-166 (ibudilast) is ongoing in Phase 2 trials in three neurological areas – all via external funding. In the drug addiction arena, a National Institute of Drug Abuse (NIDA)-funded Phase 2a trial of MN-166 (ibudilast) in opioid dependence is ongoing with investigators at Columbia University and the New York State Psychiatric Institute and a NIDA-funded Phase 2b proof-of-concept trial in methamphetamine dependence is anticipated to initiate enrollment later this year with investigators at UCLA. An investigator-funded Phase 2a trial in chronic medication overuse headache pain is near completion at the University of Adelaide in Australia.
"Our MN-166 development program is in a strong position to proceed on more than one commercial path with collaborating investigator expertise and generous funding and organizational support," said Dr. Iwaki. "We look forward to results of these important Phase 2 clinical trials" commented Dr. Iwaki.
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 for potential utility in MS. 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 including IL-1ß, TNF-a, and IL-6, and which upregulates the release of the anti-inflammatory cytokine IL-10 and neurotrophic factors such as NGF and GDNF. It attenuates the activation of brain glial cells in certain neurological conditions. Ibudilast's anti-neuroinflammatory and/or neuroprotective actions have been demonstrated in preclinical and clinical study results and provide the rationale for its therapeutic utility in progressive MS, drug addiction, and chronic neuropathic pain. MediciNova's development paths are firmly founded on issued method-of-use patents which, in the case for the treatment of Progressive MS, expires no earlier than 2029 in the U.S. A drug supply collaboration with Taisho Pharmaceutical Industries, Ltd., owned by Teva Pharmaceuticals, has expanded to include development of higher dosage strength ibudilast capsules.
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 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. 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 .
1. F. Barkhof et al., Neurology Apr 2010
2. R. Fox, Neurology Apr 2010
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 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, 2012 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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