MediciNova Announces Initiation of a Cooperative Phase 2b Trial of MN-166 in Progressive Multiple Sclerosis

MediciNova Announces Initiation of a Cooperative Phase 2b Trial of MN-166 in
Progressive Multiple Sclerosis

Unique Collaboration of Medical Centers, National Multiple Sclerosis Society,
and MediciNova, With Primary Funding and Coordination by the NIH

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 Diagnosed well after transition from
than relapsing MS                  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, theimplication 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.

CONTACT: INVESTOR CONTACT:
        
         Mike Coffee
         Chief Business Officer
         MediciNova, Inc.
         (858) 736-7180
         coffee@medicinova.com
        
         MEDIA CONTACT
         Stephanie Ashe
         (650)  245-0425
         sashe@continuumhealth.com

MediciNova, Inc. Logo