Anavex Life Sciences Receives TGA Special Access Scheme Approval for ANAVEX®2-73 (blarcamesine) for Alzheimer’s Disease Pa...
06 August 2020 - 6:05AM
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) diseases, today announced that patients from the
ANAVEX®2-73-003 phase 2a Alzheimer’s disease trial will continue
treatment with ANAVEX®2-73 (blarcamesine) via the Australian
Government Department of Health - Therapeutic Goods Administration
(TGA) compassionate use Special Access Scheme following completion
of over 5-years daily dosing of ANAVEX®2-73 (blarcamesine) and
recommendation by their physicians.
The TGA approved the Special Access Scheme
Category B applications based on the safety profile of ANAVEX®2-73
(blarcamesine), as well as clinical evidence that ANAVEX®2-73
(blarcamesine) may benefit patients. Anavex will facilitate
continued access to ANAVEX®2-73 (blarcamesine) through the Special
Access Scheme at the physicians’ request.
“We are honored to support medical professionals
and their patients seeking treatment for Alzheimer’s disease and
who have very few medical options,” commented Christopher U
Missling, PhD, President and Chief Executive Officer of Anavex.
“The Phase 2a clinical ANAVEX®2-73-002/-003 studies are exploring
the long-term effect of daily treatment with ANAVEX®2-73
(blarcamesine) over 5 years, however it is pleasing that physicians
have requested extended treatment of their patients with
ANAVEX®2-73 (blarcamesine) beyond these 5 years.”
The Special Access Scheme:
Most therapeutic goods are required to undergo
an evaluation for quality, safety, and efficacy, and be included on
the Australian Register of Therapeutic Goods (ARTG) before they can
be supplied in Australia. In recognition that there are
circumstances where patients need access to therapeutic goods that
are not listed on the ARTG, the TGA facilitates a Special Access
Scheme (SAS) for physicians seeking to use medicines that have not
yet been approved in Australia. The SAS refers to arrangements,
which provide for the supply of an unapproved therapeutic good for
individual patients. Applications under the SAS are made to the TGA
by their treating doctor, and approval to treat the patient takes
into account the safety of the drug as well as supporting evidence
that the drug may benefit the patients, along with the failure of
any current therapies.1
1
https://www.tga.gov.au/form/special-access-scheme
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. S1R
activation has demonstrated ability to reduce key
pathophysiological signs of Alzheimer’s disease: beta amyloid,
hyperphosphorylated tau, and increased inflammation. In the Phase
2a 57-week Alzheimer’s disease (AD) ANAVEX®2-73-002
(ClinicalTrials.gov NCT02244541) study, ANAVEX®2-73 (blarcamesine)
has shown dose dependent improvement in exploratory endpoints of
cognition (MMSE) and function (ADCS-ADL). Its open-label extension
study ANAVEX®2-73-003 (ClinicalTrials.gov NCT02756858) for an
additional 208 weeks included full genomic analysis of patients
with Alzheimer’s disease treated with ANAVEX®2-73 (blarcamesine). A
48-week Phase 2b/3 study ANAVEX®2-73-AD-004 (ClinicalTrials.gov
NCT03790709) of ANAVEX®2-73 (blarcamesine) in 450 patients with
early Alzheimer’s disease is ongoing and currently over 60%
enrolled.
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 clinical 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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