Anavex Life Sciences Announces Notice of Allowance for U.S. Patent Application with Expanding Claims Covering ANAVEX®2-73 (b...
November 30 2020 - 7:00AM
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 disorders including Alzheimer’s disease,
Parkinson’s disease, Rett syndrome and other central nervous system
(CNS) disorders, today announced it received a Notice of Allowance
from the United States Patent and Trademark Office (USPTO) for its
patent application number 16/717,921 expanding coverage of
treatment methods for ANAVEX®2-73 (blarcamesine) and related
sigma-1 receptor agonist drug candidates, for treating a range
neurodevelopmental disorders including Rett syndrome, autism
spectrum disorder, Angelman syndrome, cerebral palsy and multiple
sclerosis, among other indications.
Data suggests, that activation of the sigma-1
receptor is pivotal to restoring neural cell homeostasis and
promoting neuroplasticity.1
This newest U.S. patent is expected to remain in
force at least until 2037, not including any patent term
extensions. Together with U.S. Patent No. 10,507,196 granted to
Anavex in January 2020, the new patent will expand claim coverage
for use of Anavex’s sigma-1 receptor agonists in oral, transdermal
and parenteral compositions as well as for both pediatric and adult
patients.
"This patent allowance by the USPTO is not only
another important milestone in protecting the commercial potential
of ANAVEX®2-73 (blarcamesine) and Anavex’s other lead compounds,
but along with other recent allowances, demonstrates our strong
overall commitment to protecting the innovation and commercial
opportunity of our entire product portfolio," said Christopher U.
Missling, PhD, President and Chief Executive Officer of Anavex.
ANAVEX®2-73 (blarcamesine) is currently
evaluated for Rett syndrome in one completed and two ongoing
placebo-controlled clinical studies. In the U.S. Phase 2 study
(ANAVEX®2-73-RS-001)2 adult Rett syndrome patients were treated
with low-dose ANAVEX®2-73 (blarcamesine) oral liquid formulation,
while the subsequent international AVATAR Phase 2 adult Rett
syndrome study (ANAVEX®2-73-RS-002)3 and EXCELLENCE Phase 2/3
pediatric Rett syndrome study (ANAVEX®2-73-RS-003)4 is treating
patients with high-dose ANAVEX®2-73 (blarcamesine) oral liquid
formulation. ANAVEX®2-73 (blarcamesine) had previously received
Fast Track designation, Rare Pediatric Disease designation and
Orphan Drug designation from the FDA for the treatment of Rett
syndrome.
_________________________
1 Advances in Experimental Medicine and Biology
Volume 964 (2017) Sigma Receptors: Their Role in Disease and as
Therapeutic Targets.2 ClinicalTrials.gov Identifier: NCT037589243
ClinicalTrials.gov Identifier: NCT039414444 ClinicalTrials.gov
Identifier: NCT04304482
About
Rett
Syndrome
Rett syndrome is a devastating, non-inherited
genetic post-natal progressive neurodevelopmental disorder that
occurs almost exclusively in girls and leads to severe impairments,
affecting nearly every aspect of the child’s life: their ability to
speak, walk, eat and easily breathe. The hallmark of Rett syndrome
is near constant repetitive hand movements while awake. The disease
is characterized by normal early growth and development (6 to 18
months) followed by a slowing of development, loss of purposeful
use of the hands, distinctive hand movements, autistic features,
slowed brain and head growth, ataxia, seizures and intellectual
disability. Rett syndrome is caused by mutations in the MECP2 gene
and strikes all racial and ethnic groups. The disease occurs
worldwide in approximately one in every 10,000 to 15,000 live
births. There is currently no cure for Rett syndrome.
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 successfully a Phase 2a clinical trials for
Alzheimer’s disease and a Phase 2 proof-of-concept study in
Parkinson’s disease dementia. 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 clinical stage 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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