Anavex Life Sciences Announces Commitment for Financial Investment by Shake It Up Foundation for Parkinson’s Research for C...
19 August 2020 - 9:00PM
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:
AVXL), a clinical-stage biopharmaceutical company developing
differentiated therapeutics for the treatment of neurodegenerative
and neurodevelopmental diseases including Alzheimer’s disease,
Parkinson’s disease, Rett syndrome and other central nervous system
(CNS) diseases, today announced that the Shake It Up Foundation for
Parkinson’s Research and its international partners has committed
to invest into Anavex up to 50% of the costs of a disease modifying
clinical study to develop ANAVEX®2-73 (blarcamesine) for the
disease modifying treatment of Parkinson’s disease.
“Shake It Up is proud and excited to support
research like this that may create opportunities for breakthroughs
that could be a game-changer for people with
Parkinson’s,” said Clyde Campbell, Founder and CEO of the Shake It
Up Foundation. “The potential of a disease modifying treatment for
Parkinson’s disease could be a very promising next step in further
human testing of ANAVEX®2-73 (blarcamesine), in which the therapy
goes through a rigorous process to determine whether it is safe,
tolerable and efficacious.”
“We see this collaboration as an important step
in our global effort to expedite the development of ANAVEX®2-73
(blarcamesine) and to evaluate ANAVEX®2-73 (blarcamesine) for
Parkinson’s disease as a potential disease modifying agent. Shake
It Up Foundation shares our commitment to move rapidly to address
the unmet need for treatments for Parkinson’s disease, and brings
deep experience and an extensive network within the Parkinson’s
community,” said Christopher U Missling, PhD, President and Chief
Executive Officer of Anavex.
The planned clinical study will use a
convenient, once-daily oral ANAVEX®2-73 (blarcamesine) formulation
to confirm the previously established potential disease modifying
features of ANAVEX®2-73 (blarcamesine) in an animal model of
Parkinson’s disease. Safety and efficacy will be investigated in an
appropriately powered placebo-controlled clinical study of
Parkinson’s disease patients over at least 48-weeks including
ANAVEX®2-73-specific precision medicine biomarkers. All patients
who participate in the study will be eligible to receive
ANAVEX®2-73 (blarcamesine) under a voluntary open label extension
protocol.
About Shake It Up Australia Foundation for Parkinson’s
Research
Shake It Up Australia Foundation for Parkinson’s
Research is a not-for-profit organization established in 2011 and
in partnership with The Michael J. Fox Foundation (MJFF) promotes
and funds Parkinson’s disease research in Australia aimed at better
treatments and ultimately a cure. Further information is available
at https://shakeitup.org.au/.
About Parkinson’s Disease
Parkinson’s disease is a chronic and progressive
neurological disorder that is characterized by well-known motor
symptoms including tremors, stiffness of limbs, slowness of
movements, and difficulties with posture and balance, as well as by
non-motor symptoms. It is the second most common neurological
disorder and approximately one million people in the United States,
and from four to six million people worldwide, live with this
disease. Parkinson’s disease is more common in people over 60 years
of age and its prevalence is expected to increase significantly as
the average age of the population increases. Current Parkinson’s
treatments are only effective in managing symptoms of the disease,
mainly through the use of levodopa and dopamine agonists. As the
disease progresses and dopaminergic neurons continue to be lost,
these drugs eventually become less effective at treating the
symptoms.
About ANAVEX®2-73 (blarcamesine)
ANAVEX®2-73 (blarcamesine) activates the Sigma-1
receptor (S1R) protein, which serves as a molecular chaperone and
functional modulator involved in restoring homeostasis. In a Phase
2a Alzheimer’s disease (AD) study, ANAVEX®2-73 (blarcamesine) has
shown dose dependent improvement in exploratory endpoints of
cognition (MMSE) and activities of daily living (ADCS-ADL). Full
genomic analysis of ANAVEX®2-73 (blarcamesine) Phase 2a AD patients
was performed. The ANAVEX®2-73 (blarcamesine) Phase 2 Parkinson’s
disease dementia (PDD) study design includes genomic biomarkers
identified in the ANAVEX®2-73 (blarcamesine) Phase 2a AD study.
Studies of ANAVEX®2-73 (blarcamesine) in a disease modifying model
of Parkinson’s disease indicates that ANAVEX®2-73 (blarcamesine) is
well tolerated, induces significant motor recovery (p<0.05),
induces neurohistological restoration (p<0.05) and reduces
microglial activation (p<0.05), a potential biomarker of
Parkinson’s disease. Behavioral patterns were completely normal,
meaning no signs of either dystonia or stereotypic behaviors were
detected in animals receiving the treatment. These studies were
funded by The Michael J. Fox Foundation for Parkinson’s
Research.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a
publicly traded biopharmaceutical company dedicated to the
development of differentiated therapeutics for the treatment of
neurodegenerative and neurodevelopmental disorders including
Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other
central nervous system (CNS) diseases, pain and various types of
cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine),
recently completed a successful Phase 2a clinical trial for
Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) is an orally
available drug candidate that restores cellular homeostasis by
targeting sigma-1 and muscarinic receptors. Preclinical studies
demonstrated its potential to halt and/or reverse the course of
Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) also exhibited
anticonvulsant, anti-amnesic, neuroprotective and anti-depressant
properties in animal models, indicating its potential to treat
additional CNS disorders, including epilepsy. The Michael J. Fox
Foundation for Parkinson’s Research previously awarded Anavex a
research grant, which fully funded a preclinical study to develop
ANAVEX®2-73 (blarcamesine) for the treatment of Parkinson’s
disease. ANAVEX®3-71, which targets sigma-1 and muscarinic
receptors, is a promising preclinical drug candidate demonstrating
disease-modifying activity against the major hallmarks of
Alzheimer’s disease in transgenic (3xTg-AD) mice, including
cognitive deficits, amyloid and tau pathologies. In preclinical
trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial
dysfunction and neuroinflammation. Further information is available
at www.anavex.com. You can also connect with the company on
Twitter, Facebook and LinkedIn.
Forward-Looking Statements
Statements in this press release that are not
strictly historical in nature are forward-looking statements. These
statements are only predictions based on current information and
expectations and involve a number of risks and uncertainties.
Actual events or results may differ materially from those projected
in any of such statements due to various factors, including the
risks set forth in the Company’s most recent Annual Report on Form
10-K filed with the SEC. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof. All forward-looking statements are qualified in
their entirety by this cautionary statement and Anavex Life
Sciences Corp. undertakes no obligation to revise or update this
press release to reflect events or circumstances after the date
hereof.
For Further Information:
Anavex Life Sciences Corp.Research & Business
DevelopmentToll-free: 1-844-689-3939Email:
info@anavex.com
Investors & Media:
Email: ir@anavex.com
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