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 has
received a Notice of Allowance from the U.S. Patent
and Trademark Office for a pending patent application
which covers MN-166 (ibudilast) for the treatment of glioblastoma.
This new patent has improved therapeutic claims compared to
the first patent which covers MN-166 (ibudilast) for the treatment
of glioblastoma, which was granted last year, and has a later
expiration date than the first patent.
Once issued, the patent maturing from this allowed patent
application is expected to expire no earlier than February
2039. The allowed claims cover a method of treating a patient
diagnosed with glioblastoma or recurrent glioblastoma, wherein the
patient expresses methylated MGMT (O6-methylguanine-DNA
methyltransferase), using MN-166 (ibudilast) in combination with
one or more other therapeutic agents including temozolomide (TMZ),
carmustine, bevacizumab, procarbazine, hydroxyurea, irinotecan,
lomustine, nimotuzumab, sirolimus, mipsagargin, cabozantinib,
onartuzumab, patupilone (epothilone B), and recombinant oncolytic
poliovirus (PVS-RIPO). The allowed claims cover a wide range
of doses of MN-166 (ibudilast) during an optionally repeating
dosing cycle. The allowed claims also cover different types
of glioblastoma including classical glioblastoma, proneural
glioblastoma, mesenchymal glioblastoma, and neural
glioblastoma.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer
of MediciNova, Inc., commented, "We are very pleased to
receive notice that this new patent will be granted as it offers
better coverage than our first patent covering glioblastoma.
We believe it could substantially increase the potential
value of MN‑166 as we have an ongoing clinical trial of MN-166 in
combination with temozolomide for the treatment of recurrent
glioblastoma at the Dana-Farber Cancer Institute, Harvard Medical
School. Results of the glioblastoma animal model study showed
that median survival was longer in the group that received
combination treatment with MN-166 plus temozolomide compared to the
group that received the standard treatment of temozolomide alone,
and this data was presented at the American Society of Clinical
Oncology (ASCO) annual meeting. Encouragingly, the FDA
granted orphan-drug designation to MN-166 as adjunctive therapy to
temozolomide for the treatment of glioblastoma based on this
data."
About Glioblastoma
According to the American Association of Neurological
Surgeons, glioblastoma is an aggressive brain cancer that often
results in death during the first 15 months after 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 about 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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