MediciNova Announces New Data and Results of a Phase 2 Clinical Trial of MN-166 (ibudilast) in Glioblastoma Presented at the 28th Annual Meeting of the Society for Neuro-Oncology
19 Novembro 2023 - 8:00PM
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ
Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo
Stock Exchange (Code Number: 4875), today announced that
MediciNova’s collaborator, Justin Lathia PhD, Co-Director of the
Brain Tumor Research and Therapeutic Development Center of
Excellence at Cleveland Clinic Lerner Research Institute, and
Professor, Department of Molecular Medicine at Cleveland Clinic
Lerner College of Medicine of Case Western Reserve University, and
Patrick Wen, Director at the Center for Neuro-Oncology at
Dana-Farber Cancer Institute, Professor of Neurology, Harvard
Medical School, presented new data and results of a Phase 2
clinical trial of MN-166 (ibudilast) in glioblastoma (GBM) patients
at the 28th Annual Meeting of the Society for Neuro-Oncology (SNO)
held November 15 - 19, 2023 in Vancouver, Canada. The presentation
also included data from preclinical studies which evaluated the
combination of MN-166 (ibudilast) and anti-PD1 or anti-PD-L1
therapy in GBM models.
The primary endpoints of this Phase 2 clinical
trial were safety and tolerability of MN-166 (ibudilast) and
temozolomide (TMZ) combination treatment and efficacy of the
combination treatment defined as progression-free survival rate at
6 months using the RANO criteria. MN-166 (ibudilast) and TMZ
combination treatment was safe and well-tolerated, and no
unexpected adverse effects were reported.
The highlights of the presentation are as
follows:
Phase II clinical trial and immunohistochemistry
study
-
The trial enrolled a total of 62 patients, including 36 newly
diagnosed GBM (new GBM) patients and 26 recurrent GBM patients
-
Study participants’ mean age at screening was 58.9 years old for
new GBM and 59.6 years old for recurrent GBM
-
39% of patients were female in both groups
-
94% of new GBM patients and 100% of recurrent GBM patients were
Caucasian
-
All of the subjects received TMZ and MN-166 (ibudilast)
treatment
-
Progression-Free Survival at 6 months (PFS6) was 44% for new GBM
and 31% for recurrent GBM
-
Immunohistochemistry evaluation was performed for the patients
whose pre-treatment tumor tissue samples were available from
resected tumors at the initial surgery or biopsy to evaluate MIF
(macrophage migration inhibitory factor), pERK, Ki67, CD3, CD11b,
and CD74
-
CD3 expression was a good predictor for tumor progression at five
months in recurrent glioblastoma subjects treated with MN-166
(ibudilast) and TMZ as subjects with progression had higher CD3
tumor infiltration than subjects with no progression
(p<0.05)
Preclinical GBM model studies
-
C57BL/6 mice were intracranially injected with SB28 tumor cells at
4 weeks of life and then treated with either isotype control,
vehicle control, MN-166 (ibudilast), anti-PD1, anti-PDL1 or a
combination therapy
-
Median survival was 17 days for the vehicle and 28 days for the
anti-PD1 inhibitor treatment alone. The addition of MN-166
(ibudilast) to the anti-PD1 inhibitor treatment significantly
extended survival to a median of 66 days (p<0.001) for the
combination therapy.
-
Median survival was 18 days for the vehicle and 26 days for the
anti-PD-L1 inhibitor treatment alone. The addition of MN-166
(ibudilast) to the anti-PD-L1 inhibitor treatment significantly
extended survival to a median of 34 days (p<0.05) for the
combination therapy.
Kazuko Matsuda, M.D., Ph.D., M.P.H., Chief
Medical Officer of MediciNova, Inc., commented, “We are very
pleased to report the positive safety and efficacy results from the
first GBM clinical trial of MN-166. GBM’s rapid progression and
resistance to therapy poses a serious challenge to the medical
community. Evaluation of MN-166 (ibudilast) as an adjuvant therapy
with TMZ in GBM patients was generally safe and well tolerated. For
the PFS6 primary efficacy endpoint, recurrent GBM patients showed a
higher PFS6 rate compared to most historical studies. Moreover, the
preclinical studies presented at this meeting support our
postulation that adding MN-166 (ibudilast) to existing therapies,
e.g., TMZ, anti-PD1 or anti-PD-L1, improves survival more than the
individual therapies alone. We are excited by the findings
presented by our esteemed collaborators and look forward to
completing the full data analysis from the GBM clinical trial. We
are eager to evaluate MN-166 (ibudilast) in combination with
anti-PD1 and anti-PD-L1 therapies in a future clinical trial.
MediciNova is grateful to the patients and families for their
invaluable participation in our trial.”
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 such as ALS (amyotrophic lateral
sclerosis), progressive MS (multiple sclerosis), and DCM
(degenerative cervical myelopathy); and is also in development for
glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral
neuropathy), and substance use disorder. In addition, MN-166
(ibudilast) was evaluated in patients that are 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 Long COVID and substance
dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in
idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in
non-alcoholic fatty liver disease (NAFLD) is ongoing. 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, 2022 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
Medicinova (NASDAQ:MNOV)
Gráfico Histórico do Ativo
De Out 2024 até Out 2024
Medicinova (NASDAQ:MNOV)
Gráfico Histórico do Ativo
De Out 2023 até Out 2024