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 plans
to initiate a multi-center, placebo-controlled, randomized Phase 2b
trial to evaluate MN-166 (ibudilast) in chemotherapy-induced
peripheral neuropathy (CIPN).
The clinical trial is a collaborative effort
between MediciNova, the University of Sydney, and the Australasian
Gastro-Intestinal Trials Group (AGITG). Dr. Janette Vardy,
Professor of Cancer Medicine, University of Sydney in Australia,
will be the lead principal investigator. The proposed clinical
trial will evaluate MN-166 (ibudilast) as a potential treatment to
reduce acute neurotoxicity severity and CIPN in patients with
metastatic colorectal cancer. AGITG will provide funding for this
study and MediciNova will provide study drug and regulatory
support.
Yuichi Iwaki, MD, PhD, President and Chief
Executive Officer of MediciNova, Inc. commented, “We are excited to
collaborate with Dr. Vardy on this grant-funded study to further
explore the potential of MN-166 as a pharmacotherapy for CIPN. As
we recently reported, our first clinical trial in CIPN showed that
half of participants reported improved symptoms in the acute period
and showed improved neurological parameters on clinical assessment
with ibudilast treatment. There is a large unmet medical need for
patients with this disorder.”
Dr. Janette Vardy, the Principal Investigator
for this study, commented, “The findings from our initial study
were encouraging, and with the support of AGITG and MediciNova, we
plan to explore further the potential clinical utility of ibudilast
in a larger sample of patients who experience oxaliplatin-induced
acute neurotoxicity and chronic CIPN.”
About the
Chemotherapy-induced Peripheral Neuropathy
Trial
This study is a multi-center, randomized,
double-blind, placebo-controlled Phase 2b trial to determine
whether MN-166 (ibudilast) can decrease acute neurotoxicity
symptoms and CIPN, and to determine whether ibudilast treatment
results in fewer neurotoxicity-induced dose reductions in patients
with metastatic colorectal cancer receiving oxaliplatin up to six
months. We plan to enroll a total 100 patients in a 1:1
(ibudilast:placebo) ratio. Treatment (MN-166 (ibudilast) 60 mg/day
or matching placebo) will commence two days prior to the first
cycle of oxaliplatin chemotherapy and will continue for the
duration of the oxaliplatin chemotherapy.
About
Chemotherapy-induced Peripheral Neuropathy
Peripheral neuropathy is a set of symptoms
caused by damage to the nerves that are outside of the brain and
spinal cord. These distant nerves are called peripheral nerves.
Some of the chemotherapy and other drugs used to treat cancer can
damage peripheral nerves that carry sensations to the hands and
feet. This damage results in chemotherapy-induced peripheral
neuropathy (CIPN) and is a common side effect of cancer
chemotherapy. Most commonly, people complain of “pins and needles”
in their toes and fingers. CIPN may affect cancer outcomes due to
reductions in chemotherapy dosing and/or premature treatment
discontinuation and have a profound impact on quality of life and
survivorship. According to a meta-analysis which included more than
4,000 patients, CIPN prevalence was 68% when measured in the first
month after chemotherapy, 60% at 3 months, and 30% at 6 months or
more (Seretny et al., 2014). Long-term neurotoxicity is an
important issue for the growing number of cancer survivors, with
the highest number of affected patients having been treated for
breast and/or colon cancer.
About MN-166
(ibudilast)
MN-166 (ibudilast) is a first-in-class, orally
bioavailable, small molecule macrophage migration inhibitory factor
(MIF) inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor
that suppresses pro-inflammatory cytokines and promotes
neurotrophic factors. Our earlier human studies demonstrated
significant reductions of serum MIF level after treatment with
MN-166 (ibudilast). It also attenuates activated glial cells, which
play a major role in certain neurological conditions. MN-166
(ibudilast)'s anti-neuroinflammatory and neuroprotective actions
have been demonstrated in preclinical and clinical studies, which
provide the rationale for treatment of amyotrophic lateral
sclerosis (ALS), progressive multiple sclerosis (MS) and other
neurological diseases such as glioblastoma (GBM), and substance
abuse/addiction. MediciNova is developing MN-166 for ALS,
progressive MS and other neurological conditions such as
degenerative cervical myelopathy (DCM), glioblastoma, substance
abuse/addiction, and chemotherapy-induced peripheral neuropathy, as
well as prevention of acute respiratory distress syndrome (ARDS)
caused by COVID-19. MediciNova has a portfolio of patents which
covers the use of MN-166 (ibudilast) to treat various diseases
including ALS, progressive MS, and drug addiction.
About
MediciNova
MediciNova, Inc. is a publicly-traded
biopharmaceutical company founded upon developing novel,
small-molecule therapeutics for the treatment of diseases with
unmet medical needs with a primary commercial focus on the U.S.
market. MediciNova's current strategy is to focus on BC-PIV
SARS-COV-2 vaccine for COVID-19, MN-166 (ibudilast) for
neurological disorders such as progressive multiple sclerosis (MS),
amyotrophic lateral sclerosis (ALS), degenerative cervical
myelopathy (DCM), substance dependence (e.g., alcohol use disorder,
methamphetamine dependence, opioid dependence) and glioblastoma
(GBM), as well as prevention of acute respiratory distress syndrome
(ARDS) caused by COVID-19, 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) and MN-029 (denibulin). 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 BC-PIV SARS-COV-2 vaccine, MN-166,
MN-001, MN-221, 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 BC-PIV SARS-COV-2 vaccine, MN-166, MN-001, MN-221, 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, 2019 and its subsequent periodic
reports on Form 10-Q and current reports on Form 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'BrienVice PresidentMediciNova, Inc.info@medicinova.com |
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