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
clinical findings published in Cancer Chemotherapy and Pharmacology
regarding MN-166 (ibudilast) as a treatment for prevention of
chemotherapy-induced peripheral neuropathy (CIPN).
The publication, entitled “Ibudilast for
prevention of oxaliplatin-induced acute
neurotoxicity: a pilot study assessing preliminary efficacy,
tolerability, and pharmacokinetic interactions in patients with
metastatic gastrointestinal cancer”, is the result of a
collaborative effort between MediciNova and Dr. Janette Vardy,
Professor of Cancer Medicine, University of Sydney Concord Cancer
Centre in Australia. The authors report that co-administration of
MN-166 (ibudilast) with oxaliplatin resulted in improvement or
stabilization of oxaliplatin-induced neurotoxicity in the majority
of participants treated with oxaliplatin.
This prospective, open-label, sequential
crossover study was conducted to assess whether MN-166 (ibudilast)
can reduce acute peripheral neuropathy symptoms in patients with
metastatic upper gastrointestinal or colorectal cancer. A total 16
patients consented, and 14 patients completed two cycles of
oxaliplatin-containing chemotherapy, one cycle with conventional
chemotherapy (Cycle A) and one cycle of chemotherapy with
concurrent MN-166 treatment (Cycle B). As a cross-over design, each
participant acted as their own control. Participants underwent a
number of assessments for neurotoxicity on Day 3 of each cycle, and
at the completion of each cycle, including the Oxaliplatin-Specific
Neurotoxicity Scale (OSNS), the Total Neuropathy Score Clinical
(TNSc), the Functional Assessment of Cancer Therapy/Gynaecologic
Oncology Group—Neurotoxicity (FACT/GOG-Ntx13), and the National
Cancer Institute Common Terminology Criteria for Adverse Events
(NCI-CTCAE) neuropathy subscale.
Major findings from the publication are as
follows:
-
Across all neurotoxicity measures, a majority of participants
experienced either an improvement or no worsening of neurotoxicity
with MN-166 (ibudilast) treatment
-
According to OSNS assessments, 12 out of 14 participants reported
acute neurotoxicity (Grade 1 or 2) in both cycles. Of those, 10 out
of 12 participants were unchanged and 2 participants had improved
symptoms from Grade 2 to Grade 1 with MN-166 (ibudilast)
co-treatment.
-
According to score changes with FACT/GOG-Ntx13, TNSc and NCI-CTCAE,
a majority of participants had no worsening of scores at the Day 3
and end of cycle time-points for Cycle B compared to Cycle A.
-
Pharmacokinetic analysis indicated no effect of MN-166 (ibudilast)
on systemic exposure of oxaliplatin.
Yuichi Iwaki, M.D., Ph.D., President and Chief
Executive Officer of MediciNova, Inc., commented, “We are very
pleased to report positive results from this study. Acute
neurotoxicity, which predicts chronic CIPN, usually recurs with
oxaliplatin chemotherapy and in most cases, patients experience
worsening of neurotoxicity symptoms with continued
chemotherapy. What makes this remarkable is that half
of participants reported improved symptoms in the acute period and
showed improved neurological parameters on clinical assessment with
ibudilast treatment.”
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 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
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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