MediciNova Announces MN-166 (ibudilast) ALS Abstract Accepted for Presentation at the 27th International Symposium on ALS/MND...
October 30 2016 - 7:00PM
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 an abstract
regarding MediciNova’s ongoing clinical trial of MN-166 (ibudilast)
in ALS has been accepted for oral presentation at the 27th
International Symposium on ALS/MND (amyotrophic lateral
sclerosis/motor neurone disease) to be held December 7-9, 2016 in
Dublin, Ireland.
The presentation entitled "Adaptive Design
Single Centre Phosphodiesterase Type 4 (PDE-4) Inhibitor [MN-166
(Ibudilast)] Phase 1b/2a Clinical Trial Double Blind with Open
Label Extension for ALS Patients: Interim-blinded Analysis,
Behaviour of Creatinine as a Biomarker in Short Clinical Trials
[NCT02238626]" will be given by Principal investigator Dr.
Benjamin Rix Brooks, Director, Carolinas HealthCare System’s
Neuromuscular/ALS-MDA Center.
Presentation details are as
follows:
Session Date and Time: Friday, December 9,
2016, 8:50 – 9:10 am
Session: Clinical Trials
Location: Convention Center Dublin (CCD),
Spencer Dock, North Wall Quay, Dublin 1, Ireland
About the ALS Trial
MediciNova, in collaboration with Dr. Benjamin Rix
Brooks, Director, Carolinas HealthCare System's
Neuromuscular/ALS-MDA Center, is currently evaluating MN-166
(ibudilast) in both early and advanced stage ALS patients.
This ongoing trial is a randomized, double-blind,
placebo-controlled study which includes a six-month treatment
period followed by a six-month open-label extension. The study is
evaluating several efficacy endpoints including functional activity
(ALSFRS-R), respiratory function and muscle strength in subjects
with ALS. The study is configured to enroll up to 60 ALS patients
without NIV (Non-Invasive Ventilator) and up to 60 ALS patients
with NIV.
About ALS
Amyotrophic lateral sclerosis (ALS), also known as
Lou Gehrig's disease, is a progressive neurodegenerative disease
that affects nerve cells in the brain and the spinal cord. The
nerves lose the ability to trigger specific muscles, which causes
the muscles to become weak. As a result, ALS affects voluntary
movement and patients in the later stages of the disease may become
totally paralyzed. Life expectancy of an ALS patient is usually 2-5
years. According to the ALS Association, there are approximately
30,000 ALS patients in the U.S. and approximately 5,600 people in
the U.S. are diagnosed with ALS each year. Riluzole is the only
pharmaceutical treatment approved for ALS, but it has limited
efficacy.
About MN-166 (ibudilast)
MN-166 (ibudilast) has been marketed in Japan and
Korea since 1989 to treat post-stroke complications and bronchial
asthma. MediciNova is developing MN-166 for progressive MS and
other neurological conditions such as ALS and drug use disorders.
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 and promotes neurotrophic
factors. It attenuates activated glia cells, which play a major
role in certain neurological conditions. Ibudilast's
anti-neuroinflammatory and neuroprotective actions have been
demonstrated in preclinical and clinical study results and provide
the rationale for its therapeutic utility in neurodegenerative
diseases (e.g., progressive MS and ALS), substance use disorders
and chronic neuropathic pain. MediciNova has a portfolio of
patents which cover the use of MN-166 (ibudilast) to treat various
diseases including progressive MS, ALS, and drug addiction.
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 MN-166
(ibudilast) for neurological disorders such as progressive MS, ALS
and substance dependence (e.g., alcohol use disorder,
methamphetamine dependence, opioid dependence) and MN-001
(tipelukast) for fibrotic diseases such as nonalcoholic
steatohepatitis (NASH) and idiopathic pulmonary fibrosis
(IPF). MediciNova’s pipeline also includes MN-221
(bedoradrine) for the treatment of acute exacerbations of asthma
and MN-029 (denibulin) for solid tumor cancers. MediciNova is
engaged in strategic partnering and other potential 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-166, MN-221, MN-001, and MN-029.
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-166, MN-221, MN-001, and MN-029 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, 2015 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.
INVESTOR CONTACT:
Geoff O'Brien
Vice President
MediciNova, Inc.
info@medicinova.com
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