MediciNova to Present Data on MN-001 for the Treatment of NASH (Nonalcoholic
Steatohepatitis) During the JDDW 2014 (Japan Digestive Disease Week 2014)
LA JOLLA, Calif., July 7, 2014 (GLOBE NEWSWIRE) -- MediciNova, Inc. a
biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and
the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today
announced that it will present at the 56th Annual Meeting of the Japanese
Society of Gastroenterology and the 18th General Meeting of the Japan Society
of Hepatology during the Japan Digestive Disease Week (JDDW) 2014 in Kobe,
Preclinical data have demonstrated the benefits of MN-001 for the treatment of
NASH (nonalcoholic steatohepatitis) in an animal model. The presentation at
the 56th Annual Meeting of the Japanese Gastroenterology and the 18th General
Meeting of the Japan Society of Hepatology will extend understanding about the
mechanism by which MN-001 improves pathology in NASH, for which there is a
large unmet medical need.
Details of the presentation are as follows:
Meeting: The 56th Annual Meeting of the Japanese Society of Gastroenterology
Time: October 23, 2014, Thursday, 14:50 pm
Title: The Effect of Tipelukast (MN-001) on Mouse NASH
Meeting: The 18th General Meeting of the Japan Society of Hepatology
Time: October 24, 2014, Friday, 10:15 am
Title: The Genetic Analysis of Mouse NASH Model treated by Tipelukast (MN-001)
About NASH (nonalcoholic steatohepatitis)
According to the U.S. National Digestive Diseases Information Clearinghouse
(NDDIC), NASH prevalence in the U.S. is 2-5%. An additional 10-20% of
Americans have fat in their liver, but no inflammation or liver damage, a
condition called "fatty liver." The underlying cause of NASH is unclear, but
it most often occurs in persons who are middle-aged and overweight or obese.
Many patients with NASH have elevated serum lipids, diabetes or pre-diabetes.
Progression of NASH can lead to liver cirrhosis. Liver transplantation is the
only treatment for advanced cirrhosis with liver failure. At this time, there
is no treatment for NASH.
MN-001 is a novel, orally bioavailable small molecule compound thought to
exert its effects through several mechanisms to produce its anti-inflammatory
activity in preclinical models, including leukotriene (LT) receptor
antagonism, inhibition of phosphodiesterases (PDE) 3 and 4, and inhibition of
5-lipoxygenase (5-LO). It is postulated that inhibition of the 5-LO pathway
exerts anti-inflammatory actions, which has implications in various
inflammatory diseases such as arthritis, osteoarthritis, and allergy.
Recently, 5-LO has been postulated as a pathogenic factor in fibrotic changes.
MN-001's inhibitory effect on 5-LO and the 5-LO/LT pathway is considered to be
a novel approach to treat fibrosis.
Previously, MediciNova evaluated MN-001 for its potential clinical efficacy in
asthma and had positive Phase 2 results. MN-001 has been exposed to more than
600 subjects and considered generally safe and well-tolerated.
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 MN-166 (ibudilast) for
neurological disorders, MN-221 for the treatment of acute exacerbations of
asthma, and MN-001 for NASH and IPF. 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 its 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 the future
development and efficacy of MN-001. 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," "considering," "planning" 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-001 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, 2013 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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