MediciNova Announces Positive Results in Study of MN-001 in Mouse Model of
SAN DIEGO, June 11, 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 positive results from a study that examined the potential clinical
efficacy of MN-001 (tipelukast) for the treatment of pulmonary fibrosis.
MN-001, which was administered orally once daily (30, 100 and 300 mg/kg) for 2
weeks, was evaluated in a mouse model of bleomycin-induced pulmonary fibrosis
(PF) as measured by CT evaluation of lung density, degree of pulmonary
fibrosis using the Ashcroft score based on histopathological staining, and
hydroxyproline content, which is an indicator of fibrosis or storage of
collagen in tissue.
MN-001 significantly decreased (p<0.05) the Ashcroft score compared to Vehicle
group after 2 weeks of treatment and MN-001 reduced lung density when compared
to the Vehicle-treated group. Moreover, lung hydroxyproline content was
significantly reduced compared to the Vehicle group (p<0.01). These results
show that treatment with MN-001 has significant anti-fibrogenic effects in
bleomycin-induced pulmonary fibrosis in mice.
Earlier this year (January 14, 2014), MediciNova reported that MN-001
significantly reduced fibrosis area in the liver compared with vehicle
(p<0.01) in the mouse model of nonalcoholic steatohepatitis (NASH), as
demonstrated by a reduction in liver hydroxyproline content, and MN-001
significantly improved NAFLD activity score (NAS) (p <0.01). Together with
today's reported results, MN-001 has demonstrated anti-fibrotic properties in
multiple models of fibrosis.
MediciNova previously opened an Investigational New Drug (IND) application
with the Division of Pulmonary, Allergy, and Rheumatology Products (DPARP) for
MN-001 and will consult with the Division regarding proceeding with Phase 2
clinical development for the treatment of pulmonary fibrosis.
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.
About Bleomycin-induced Pulmonary Fibrosis Model
Bleomycin is an anti-cancer drug used for treatment of different types of
malignant tumors. One of the known side effects of bleomycin treatment is
pulmonary fibrosis. Bleomycin-induced pulmonary fibrosis in the mouse is
widely used as animal model of pulmonary fibrosis.
About Pulmonary Fibrosis
Pulmonary fibrosis (PF) is a progressive disease characterized by scarring of
the lungs that thickens the lining, causing an irreversible loss of the
tissue's ability to transport oxygen. The causes of PF are variable such as
anti-cancer drug therapy or exposure to chemicals. Idiopathic Pulmonary
Fibrosis (IPF) is one type of PF without a clear cause.According to the
Coalition for Pulmonary Fibrosis, IPF affects approximately 128,000
individuals in the U.S., with about 48,000 new cases diagnosed annually. The
prognosis for IPF is poor and about two-thirds of patients die within 5 years
of diagnosis. There are no pharmaceutical treatments approved for IPF in the
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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