Anavex Life Sciences Announces Initiation of the EXCELLENCE ANAVEX®2-73-RS-003 Clinical Study in Pediatric Patients with Ret...
September 04 2019 - 6:00AM
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) diseases, today announced the approval to initiate the
ANAVEX®2-73-RS-003 clinical study of approximately 69 pediatric
patients with Rett syndrome, aged 5 to 18, called EXCELLENCE
(ANAVEX®2-73 (blarcamesine) in a Double-Blind, Randomized,
Placebo-Controlled Safety and Efficacy Study in Pediatric Patients
with Rett Syndrome). The EXCELLENCE study is designed as an
international study with the first approval by the Australian Human
Research Ethics Committee and scheduled to initiate within the next
quarters.
Safety and efficacy will be investigated in
approximately 69 patients over a 12-week treatment period including
ANAVEX®2-73-specific precision medicine biomarkers using a
convenient once-daily oral liquid ANAVEX®2-73 (blarcamesine)
formulation to treat Rett syndrome. All patients who participate in
the study will be eligible to receive ANAVEX®2-73 (blarcamesine)
under a voluntary open label extension protocol. This study is part
of the planned Anavex Rett Syndrome Program including ongoing and
further studies of ANAVEX®2-73 (blarcamesine) in wider age range
and other geographic regions.
For parents who wish to learn more about
the EXCELLENCE pediatric
Rett syndrome clinical study, please visit the
website,
www.rettsyndrometrial.com.
Previously, administration of ANAVEX®2-73
resulted in both significant and dose-related improvements in an
array of neurologic paradigms in the Mecp2 heterozygous Rett
syndrome mouse model at different ages. These paradigms measured
different sensory, motor, and autonomic abnormalities of relevance
to Rett syndrome, including motor coordination and balance; gait
abnormalities; hindlimb clasping, a model of the characteristic
hand stereotypies in individuals with Rett syndrome; acoustic
startle response; and, in older animals, visual acuity and
breathing abnormalities. This data was presented at scientific
meetings and is scheduled to be published in a peer-reviewed
journal. Anavex is utilizing innovative strategies in trial design
in order to effectively and efficiently translate preclinical and
clinical findings into an exploration of ANAVEX®2-73 (blarcamesine)
as a potential therapeutic in Rett syndrome.
Rett syndrome, which is seen almost exclusively
in girls, is a severe genetic disorder in which the brain does not
mature properly and there is progressive neurologic impairment that
leads to shorter lifespan and diminished quality of life. It
affects multiple neurologic aspects, including ability to
communicate, ability to walk and other intellectual functions, hand
function, and also to certain extent breathing abnormalities,
behavioral problems, and seizures.
“This study highlights Anavex’ commitment to all
families of young girls with Rett syndrome to be able to offer a
potential treatment to a broader age range complementing the
ongoing clinical studies in the U.S. and the AVATAR study in adult
patients with Rett syndrome,” said Christopher U Missling, PhD,
Chief Executive Officer of Anavex. “There are currently no approved
therapies for Rett syndrome and we are looking forward to working
with the Rett syndrome community worldwide to developing
transformative therapies for people and their families living with
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 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 M1 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
Anavex Life Sciences (NASDAQ:AVXL)
Historical Stock Chart
From Apr 2024 to May 2024
Anavex Life Sciences (NASDAQ:AVXL)
Historical Stock Chart
From May 2023 to May 2024