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 the first
glioblastoma patient has enrolled in the clinical trial of MN-166
(ibudilast) in combination with temozolomide (TMZ, Temodar‑®) for
the treatment of recurrent glioblastoma (GBM). The principal
investigators are Patrick Y. Wen, M.D., Professor of Neurology,
Harvard Medical School and Director, Neuro-Oncology Division at the
Dana-Farber Cancer Institute (DFCI) in Boston, and Kerrie McDonald,
Ph.D., Associate Professor and Head of Biomarkers and Translational
Research at the Lowy Cancer Research Centre, University of New
South Wales, Australia.
The scientific rationale for this clinical trial is based on
positive results from preclinical studies conducted by Dr. McDonald
and her team. MN-166 (Ibudilast) and temozolomide (TMZ) combination
treatment significantly increased GBM cell apoptosis and cell cycle
arrest in an in-vitro study. Combination treatment of MN-166
(ibudilast) with TMZ resulted in significantly extended survival
times compared to TMZ monotherapy in a GBM animal model study with
complete tumor regression observed in two out of 16 mice.
This is the first clinical trial to evaluate the safety,
tolerability and preliminary efficacy of MN-166 (ibudilast) in
combination with temozolomide for the treatment of recurrent
GBM.
Patrick Y. Wen, M.D., principal investigator, commented, “We are
very excited to study ibudilast with TMZ combination treatment as
we believe ibudilast’s mechanisms of action and good penetration of
the blood-brain barrier could benefit patients with recurrent
GBM.”
Kerrie McDonald, Ph.D., Associate Professor, University of New
South Wales, Australia, commented, “Earlier studies indicate that
macrophage migration inhibitory factor (MIF) and phosphodiesterase
(PDE)-4 may factor in proliferation of GBM tumors. MIF was
found to be highly expressed within GBM cells, and especially
around necrotic areas and in close proximity to blood vessels.
Ibudilast in combination with TMZ resulted in significant blockage
of MIF expression, increased apoptosis, and longer survival in
vivo.”
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of
MediciNova, Inc., commented, "We are very pleased that enrollment
has commenced for this trial at Dana-Farber Cancer Institute, one
of the most highly rated cancer treatment institutions in the U.S.
We believe MN-166 offers a novel approach to treating GBM, a highly
lethal form of cancer that develops from glial cells.”
About the Clinical Trial
This Phase 1/2 clinical trial is divided into a dose-escalation
phase (Part 1) followed by a fixed-dose phase (Part 2). A total of
15-18 adult subjects are planned to be enrolled in Part 1 and
approximately 32 subjects are planned to be enrolled in Part 2.
Part 1 will evaluate the safety and tolerability of MN-166
(ibudilast) when given in combination with TMZ, and determine the
dose of MN-166 (ibudilast) to be used in Part 2 of the study. Part
2 will evaluate the efficacy of MN-166 (ibudilast) and temozolomide
combination treatment in patients with recurrent GBM as measured by
the proportion of patients who are progression-free at 6 months.
Other outcome measures include the evaluation of overall survival,
response rate, and median six-month progression-free survival.
About Glioblastoma
According to the American Association of Neurological Surgeons,
GBM is a devastating brain cancer that typically results in death
in the first 15 months after diagnosis. GBM develops from glial
cells (astrocytes and oligodendrocytes) and rapidly grows and
commonly spreads into nearby brain tissue. GBM 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 GBM represents 15% of all brain tumors and 56% of all
gliomas and has the highest number of cases of all malignant
tumors, with an estimated 12,760 new cases predicted for 2018.
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 GBM. Median survival is 14.6 months and
two-year survival is 30%. Approximately 5% of GBM patients survive
longer than 36 months.
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. It 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 progressive multiple sclerosis (MS) and
other neurological diseases such as amyotrophic lateral sclerosis
(ALS), substance abuse/addiction and glioblastoma (GBM). MediciNova
is developing MN-166 for progressive MS and other neurological
conditions such as ALS, substance abuse/addiction,
chemotherapy-induced neuropathy, and glioblastoma. MediciNova has a
portfolio of patents which cover the use of MN-166 (ibudilast) to
treat various diseases including progressive MS, ALS, and drug
addiction.
About MediciNovaMediciNova,
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),
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-221, MN-001, 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-221, MN-001, 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, 2017 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'Brien Vice President MediciNova, Inc.
info@medicinova.com
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