Rett Syndrome Association of Australia and Anavex Life Sciences Announce Initiation of the Phase 2 AVATAR Clinical Study in P...
May 08 2019 - 8:00AM
Rett Syndrome Association of Australia and 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 the approval by the Australian Human Research Ethics
Committee to initiate an approximately 30 patient Phase 2
double-blind, randomized, placebo-controlled, study of ANAVEX®2-73
for the treatment of Rett syndrome, called AVATAR (ANAVEX®2-73
assessment of safety and efficacy in Rett syndrome patients). The
AVATAR study is scheduled to initiate this quarter.
The Phase 2 study will use a convenient
once-daily oral liquid ANAVEX®2-73 formulation to treat Rett
syndrome. Safety and efficacy will be investigated in approximately
30 patients over a 7-week treatment period including
ANAVEX®2-73-specific precision medicine biomarkers. All patients
who participate in the study will be eligible to receive
ANAVEX®2-73 under a voluntary open label extension protocol. This
study is part of a planned Anavex Rett syndrome program including
further studies of ANAVEX®2-73 in wider age range and other
geographic regions.
About the AVATAR Rett Syndrome Clinical Phase 2
Study
For patients who wish to learn more about this study,
please visit the website,
www.rettsyndrometrial.com.
RSAA will also make the necessary bookings and
pay for them directly so as not to burden and leave participants
and their families out of pocket for major expenses whilst directly
participating in the AVATAR trial. Please contact Claude Buda, RSAA
President, directly by phone or email for any inquiries:
Claude Buda, RSAA PresidentPhone: +61
(0)411 089 156Email:
claudebuda@rettaustralia.org.au
Previously, administration of ANAVEX®2-73
resulted in both significant and dose related improvements in an
array of behavioral paradigms in two MECP2 HET Rett syndrome
disease models. These behavioral paradigms measured different
aspects of muscular coordination, balance, motor learning and
muscular strengths, some of the core deficits observed in Rett
syndrome. 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 as a potential
therapeutic in Rett syndrome.
“Rett syndrome, which is seen almost exclusively
in females, is a genetic disorder in which the brain does not
mature in the way it should. For most affected children, their
early development appears normal but then slows down or suddenly
halts, said Claude Buda, President of RSAA. “There are currently no
approved therapies for Rett syndrome and we welcome the opportunity
to explore a disease-modifying treatment option to Australian
families.”
“We are proud to have partnered with the Rett
Syndrome Association of Australia in the design of the AVATAR study
and thrilled that we have taken an important step in advancing the
development of a potential treatment for Rett syndrome that may
benefit the families and individuals living with this disorder,”
said Christopher U Missling, PhD, Chief Executive Officer of
Anavex.
Walter E Kaufmann, MD, Chief Medical Officer of
Anavex commented, “ANAVEX®2-73 highlights our commitment to
developing transformative therapies for people and their families
living with Rett syndrome.”
About Rett Syndrome Association of Australia
(RSAA)
Formed in Melbourne in July 1989, the Rett
Syndrome Association of Australia Inc. (RSAA) is a not-for-profit
organisation which is managed by a Committee of volunteers, most of
whom are parents of Rett syndrome children. July 2019 will mark
RSAA’s 30th anniversary. The Association seeks to improve the
quality of life for persons with the syndrome and their families
and be of assistance to anyone interested in the disorder.Please
click www.rettaustralia.org.au to read more about RSAA.
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 diseases 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, recently
completed a successful Phase 2a clinical trial for Alzheimer’s
disease. ANAVEX®2-73 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 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 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
neuroinflammation and mitochondrial dysfunction. 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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