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 its
participation at the Kick-off Meeting for the Phase 3 trial,
“REgeneration in CErvical DEgenerative Myelopathy (RECEDE
Myelopathy)”, a collaboration with University of Cambridge
researchers, as well as at the first UK Academic Spine Symposium,
which took place on Tuesday, May 7, 2019 at the Royal Society of
Medicine in London, UK
.
Following the events, Yuichi Iwaki, M.D., Ph.D., President and
Chief Executive Officer gave a speech for the official launch of
Myelopathy.org hosted by Lord Carter of Coles in the UK Parliament
House of Lords on supporting innovative science through its
collaboration in the RECEDE Myelopathy Phase 3 trial to evaluate
MN-166 (ibudilast) in degenerative cervical myelopathy (DCM)
patients. Fellow speakers included H.E. Mr. Koji Tsuruoka,
Ambassador Extraordinary and Plenipotentiary, Embassy of Japan in
the UK as well as world-renown Spine Surgeon and Researcher,
Professor Michael Fehlings, M.D., Ph.D., Vice-Chair Research for
the Department of Surgery at the University of Toronto.
The RECEDE Myelopathy Phase 3 trial is being conducted under an
agreement between MediciNova, the University of Cambridge, and
Cambridge University Hospitals NHS Foundation Trust. Funding for
the trial is being provided by the United Kingdom National
Institute for Health Research (NIHR). Its Chief Investigator is
Mark Kotter, M.D., Ph.D., NIHR Clinician Scientist and Consultant
in Neurosurgery at the University of Cambridge. The trial will
evaluate MN-166 (ibudilast) as an adjuvant treatment for DCM
following spinal surgery and determine whether MN-166 (ibudilast)
is more effective than placebo in improving outcomes.
Myelopathy.org, founded by myelopathy sufferer Iwan Sadler, Dr.
Kotter and his colleagues, is the world’s first patient support
charity for DCM, a collaborative initiative between researchers,
health professionals, myelopathy patients and their advocates.
Mark Kotter, MD PhD, Chief Investigator of the RECEDE Myelopathy
study, commented, “We are very excited to collaborate with
MediciNova to evaluate MN-166 for the treatment of DCM. MN‑166 has
the potential to benefit DCM by addressing the three hallmarks of
DCM pathology: by promoting nerve re-growth, stimulating the repair
of myelin sheaths, and by alleviating the consequences of reduced
blood flow in the spinal cord. We believe that MN-166 has potential
clinical utility in DCM. We are also highly appreciative to
MediciNova and the Japanese Embassy’s support for Myelopathy.org,
the first charity for the DCM community.”
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of
MediciNova, Inc., commented, “We are very pleased to provide our
promising new treatment, MN-166 to DCM patients and we are excited
to work in collaboration with Dr. Kotter to explore the effects of
MN-166 as a pharmacotherapy in DCM. We are also highly appreciative
of the funding and support by NIHR.”
About the RECEDE Myelopathy Trial
The clinical trial, titled “Regeneration in
Cervical Degenerative
Myelopathy – a multi-centre, double-blind,
randomised, placebo-controlled trial assessing the efficacy of
ibudilast as an adjuvant treatment to decompressive surgery for
degenerative cervical myelopathy,” plans to enroll up to 80
subjects in the initial phase of the trial (stage 1) with planned
enrollment of 362 subjects, overall. Two to three months prior to
decompressive surgery, eligible subjects will be randomly assigned
to receive either MN‑166 (ibudilast) at doses up to 100 mg/day or
matching placebo. Study drug treatment will continue for 8 months
and subjects will be evaluated at the clinic at 3, 6, and 12 months
following surgery. The study was designed on the basis of patient
input, including a survey of 481 patients hosted by Myelopathy.org
regarding their recovery priorities. Its two co-primary endpoints
assess changes in pain and function 6 months after surgery as
compared to baseline at enrollment. Pain will be measured using the
Visual Analogue Scale (VAS). Changes in function will be measured
using the modified Japanese Orthopaedic Association (mJOA) Score,
which evaluates motor dysfunction in upper and lower extremities,
loss of sensation, and sphincter dysfunction. Other study outcome
measures include neurological exam, GRASSP (measures hand
function), Spinal Cord Independence Measure version 3, or SCIMv3
(measures activities of daily independent living), 30-meter walk
test, Neck Disability Index (NDI), EQ-5D and SF-36 questionnaires
(measures quality of life), QuickDASH (measures disabilities of the
arm, shoulder, and hand) and safety and tolerability.
About Degenerative Cervical Myelopathy
According to British Medical Journal Article
(BMJ 2018; 360 doi: https://doi.org/10.1136/bmj.k186)
Degenerative Cervical Myelopathy (DCM) is defined as compression of
the spinal cord in the neck which can lead to paralysis. DCM is a
common, progressive neurological disease caused by aging,
arthritis, and degenerative spinal conditions such as spinal
stenosis, central disc herniation, and ossification of the
posterior longitudinal ligament (oPLL). Information of the American
Association of Neurological Surgeons, states that more than 200,000
cervical procedures are performed each year to relieve compression
on the spinal cord or nerve roots. Compression of spinal nerves
leads to neurological dysfunction such as numbness, tingling, pain
and stiffness in the neck and pain and numbness in the arms,
fingers, or hands. Patients may experience muscular abnormalities
including, but not limited to, problems with balance and walking,
incoordination, muscle weakness in arms, shoulders, or hands,
rhythmic muscle spasm, stiff muscles, loss of muscle, overactive
reflexes, and loss of bladder and bowel control. Depending on the
severity of symptoms, the options for treatment of DCM are a
movement-restricting collar, physical therapy, pain relievers,
muscle relaxants, and surgery. Currently, no cure exists and there
is no approved medication to treat DCM.
About Myelopathy.org
Myelopathy.org is the first nonprofit organization dedicated to
DCM. Its mission is “to raise awareness and support patients,
carers and professionals who live and deal with the condition”.
Dr Mark Kotter, Ben Davies, trainee neurosurgeon and Research
Fellow of the Royal College of Surgeons, and myelopathy-sufferer
Mr. Iwan Sadler, co-founded Myelopathy.org as a forum for
individuals with myelopathy where they can come together and share
their experiences. It aims to provide people with myelopathy a
unified voice, to educate health professionals and to disseminate
accurate information about DCM. Further aims are to support
research and to effect change, for example by improving diagnosis
of DCM and patient pathways.
About MN-166 (ibudilast)
MN-166 (ibudilast) is a first-in-class, orally bioavailable,
small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and
macrophage migration inhibitory factor (MIF) inhibitor that
suppresses pro-inflammatory cytokines and promotes neurotrophic
factors. It modulates 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 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 acquiring and 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, 2018 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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