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
preclinical findings published in Frontiers in Immunology regarding
the prospect of MN-166 (ibudilast) as an adjunct treatment for
glioblastoma.
The publication, entitled “Glioblastoma
myeloid-derived suppressor cell subsets express differential
macrophage migration inhibitory factor receptor profiles that can
be targeted to reduce immune suppression”, was a collaborative
effort between MediciNova and the Cleveland Clinic, led by Tyler
Alban (doctoral candidate) and Dr. Justin Lathia, Co-Director of
the Brain Tumor Research and Therapeutic Development Center of
Excellence at the Lerner Research Institute, Cleveland Clinic, and
Associate Professor, Department of Molecular Medicine at Case
Western Reserve University. Dr. Lathia, Dr. Michael Vogelbaum
(previously at the Cleveland Clinic, now at Moffitt Cancer Center
in Tampa, FL) and colleagues previously reported on findings that
GBM patients had higher levels of immune suppressive
myeloid-derived suppressor cells (MDSCs) in the tumor
microenvironment and they tended to be resistant to and dependent
on macrophage migration inhibitory factor (MIF). In this research
publication, in collaboration with Dr. Richard Bucala (Yale
University), they report the monocytic subset of MDSCs (M-MDSCs)
expressed high levels of the MIF cognate receptor CD74 in the tumor
microenvironment. This finding is meaningful in that targeting
M-MDSCs with ibudilast, a brain penetrant MIF-CD74 interaction
inhibitor, resulted in decreased MDSC function and enhanced CD8 T
cell activity in the tumor microenvironment. They note that
clinical trial results to date suggest that treatment with an
immune stimulatory therapy alone is not effective in treating GBM
and hypothesized that better clinical outcomes will be seen when an
immune stimulatory therapy is combined with ibudilast, which has
been shown to reverse tumor-induced immune suppression.
Dr. Justin Lathia commented, “We found that the
receptor CD74 may play a greater role in GBM MDSC biology because
the subset of MDSCs primarily found in the tumor microenvironment
were M-MDSCs, which predominantly express CD74 as a MIF receptor.
These findings are significant for treating patients diagnosed with
GBM. Among multiple anti-MIF agents we tested, ibudilast was most
potent with reducing M-MDSCs. Ibudilast readily crosses the
blood-brain barrier, an advantage over other agents, and has a
strong safety profile. Our hope is that combining ibudilast and
immune stimulatory therapy will translate to decreased disease
progression in clinical trials.”
Yuichi Iwaki, MD, PhD, President and Chief
Executive Officer of MediciNova, Inc., commented, "We have an
ongoing clinical trial evaluating MN-166 in combination with
temozolomide for the treatment of GBM at the Dana-Farber Cancer
Institute, Harvard Medical School. Recently, we expanded our
target population to include patients with either recurrent or
newly diagnosed GBM. A recently published GBM animal model study
showed that median survival was longer in the group treated with
MN-166 plus temozolomide than in the group treated with
temozolomide alone. The new findings reported by Dr. Lathia and his
colleagues may lead to the use of MN-166 as combination therapy
with immune stimulatory treatment and may offer a new treatment
option to patients with GBM, one of the most serious refractory
cancers.”
About Glioblastoma
According to the American Association of
Neurological Surgeons, glioblastoma is an aggressive brain cancer
that often results in death within 15 months of diagnosis.
Glioblastoma develops from glial cells (astrocytes and
oligodendrocytes), grows rapidly, and commonly spreads into nearby
brain tissue. Glioblastoma is classified as Grade IV, the highest
grade, in the World Health Organization (WHO) brain tumor
grading system. The American Brain Tumor
Association reports that glioblastoma represents about 15% of
all primary brain tumors and approximately 10,000 cases of
glioblastoma are diagnosed each year in the U.S. Despite decades of
advancements in neuroimaging, neurosurgery, chemotherapy and
radiation therapy, only modest improvements have been achieved and
the prognosis has not improved for individuals diagnosed with
glioblastoma. Median survival is approximately 11-15 months
for adults with more aggressive glioblastoma (IDH-wildtype) who
receive standard treatment of surgery, temozolomide, and radiation
therapy.
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.
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 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), 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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