MediciNova Announces New Data regarding MN-166 (ibudilast) in Uveal Melanoma Presented at the CURE OM Global Science Meeting
November 10 2021 - 6:00PM
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 Grazia
Ambrosini, PhD, an associate research scientist at Columbia
University Vagelos College of Physicians and Surgeons, presented
data regarding MN-166 (ibudilast) in a uveal melanoma (UM) model
study at the 10th Annual CURE OM Global Science Meeting held online
as a part of the Society for Melanoma
Research International Congress on October 28, 2021.
This study was a collaborative effort between
MediciNova and Dr. Ambrosini, Richard D. Carvajal, MD, associate
professor of medicine at Columbia Vagelos College of Physicians and
Surgeons and co-director of the Precision Oncology and Systems
Biology research program at the Herbert Irving Comprehensive Cancer
Center (HICCC), and Gary Schwartz, MD, professor of oncology at
Vagelos College of Physicians and Surgeons, Division Chief of
Hematology/Oncology at Columbia University Irving Medical Center,
and Deputy Director at the HICCC.
The highlights of Dr. Ambrosini’s presentation
are follows:
-
The role of UM exosomes in the crosstalk with hepatic cells was
investigated in co-culture migration assays and in a mouse
metastatic model.
-
UM exosomes induce activation of cell signaling pathways and the
release of cytokines and growth factors from hepatocytes. The
exosome-stimulated hepatocyte conditioned media (HCM) could in turn
induce migration of UM cells.
-
Macrophage migration inhibitory factor (MIF) was the major player
in these mechanisms and its blockade inhibited cell migration in
co-cultures with exosome-stimulated hepatocytes and prevented the
development of metastases in vivo.
-
MN-166 reduced migrated UM cell count in UM-exosome-stimulated HCM
(p<0.001).
-
Quantified bioluminescence intensity for each animal in the
abdominal region was significantly reduced by MN-166 treatment in
the UM mouse model (p<0.05).
-
MN-166 prevented metastasis in a mouse UM metastasis model.
Dr. Carvajal commented, “We are excited about
the preclinical data generated with the MIF inhibitor MN-166 in
this uveal melanoma model study. Uveal melanoma is the most common
primary intraocular malignancy and nearly half of patients
ultimately will develop metastasis. Metastases are most frequently
localized to the liver and associated with a poor prognosis.
Currently there are no effective preventive treatments for uveal
melanoma. Previously, our group identified MIF as a critical
mediator of metastatic spread. In our new study, MN-166 treatment
prevented remote metastasis in the orthotopic uveal melanoma
model.”
Kazuko Matsuda, M.D. Ph.D, MPH., Chief Medical
Officer, MediciNova, Inc., commented, “In clinical practice, cancer
metastasis is often the major driver of cancer-related death rather
than the primary cancer. We are very excited about MN-166’s
potential to prevent metastasis in uveal melanoma. We previously
reported that MN-166 reduced levels of immune suppressive
myeloid-derived suppressor cells (MDSCs) and enhanced CD8 T cell
activity in the tumor microenvironment. The new data from this UM
model study suggested that treatment with MN-166 can potentially
address significant unmet medical needs for novel and effective
therapies for patients with UM at risk of metastasis. We are
looking forward to moving to a clinical trial and we are optimistic
that this project could help patients with uveal melanoma and other
malignancies.”
About MN-166 (ibudilast)
MN-166 (ibudilast) is a small molecule compound
that inhibits phosphodiesterase type-4 (PDE4) and inflammatory
cytokines, including macrophage migration inhibitory factor (MIF).
It is in late-stage clinical development for the treatment of
neurodegenerative diseases including ALS, progressive MS (multiple
sclerosis), and DCM (degenerative cervical myelopathy);
glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy),
and substance use disorder. In addition, MN-166 (ibudilast) is
being evaluated in patients at risk for developing acute
respiratory distress syndrome (ARDS).
About MediciNova
MediciNova, Inc. is a clinical-stage
biopharmaceutical company developing a broad late-stage pipeline of
novel small molecule therapies for inflammatory, fibrotic, and
neurodegenerative diseases. Based on two compounds, MN-166
(ibudilast) and MN-001 (tipelukast), with multiple mechanisms of
action and strong safety profiles, MediciNova has 11 programs in
clinical development. MediciNova’s lead asset, MN-166 (ibudilast),
is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and
degenerative cervical myelopathy (DCM) and is Phase 3-ready for
progressive multiple sclerosis (MS). MN-166 (ibudilast) is also
being evaluated in Phase 2 trials in glioblastoma, patients at risk
of developing acute respiratory distress syndrome (ARDS), and
substance dependence. MN-001 (tipelukast) was evaluated in a Phase
2 trial in idiopathic pulmonary fibrosis (IPF) and is in
preparation for a second Phase 2 trial in nonalcoholic
steatohepatitis (NASH). MediciNova has a strong track record of
securing investigator-sponsored clinical trials funded through
government grants.
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, 2020 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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