Full Press Release Details
ANAVEX RECEIVES APPROVAL TO COMMENCE PHASE I CLINICAL
IN ALZHEIMER S DISEASE
ANAVEX 2-73 trial to be initiated immediately in
Hoboken, NJ March 15, 2011 -- Anavex Life Sciences
Corp. ( Anavex ) (OTCBB: AVXL) today announced that its clinical trial
application (CTA) for ANAVEX 2-73, the company s lead compound for Alzheimer s
disease, has been approved by the German regulatory health authority, BfArM. The
Phase I trial of ANAVEX 2-73, which includes testing in healthy human
volunteers, will commence immediately. In this Phase I program Anavex will
assess the safety, maximally tolerated dose, pharmacokinetics and
pharmacodynamics of ANAVEX 2-73.
We are excited to have received the German regulatory health
authority s approval to take ANAVEX 2-73 into the clinic. This marks a key
milestone for our company, said Dr. Cameron Durrant, Executive Chairman of
We are very pleased to have received this approval, which
supports the data generated thus far on ANAVEX 2-73. The CTA package submitted
was of the quality required to pass this stringent regulatory review by the
Germany Health Authority, BfArM, said Dr. Angelos Stergiou, Anavex s Vice
President, Clinical Development & Medical Affairs.
ANAVEX 2-73 is the first of a new class of wholly owned
compounds that act through sigma-1 receptor agonism as well as muscarinic and
cholinergic effects and modulation of endoplasmic reticulum stress to trigger a
series of intracellular effects thought to modify ion channel signalling at the
mitochondrial level.
I wholeheartedly support ANAVEX 2-73 progressing into Phase I.
I have been following the progress of this drug and I hope this important trial
will be just the beginning of an exciting journey we have ahead of us, said Dr.
Jeffrey Cummings, member of the Anavex Scientific Advisory Board, Professor of
Neurotherapeutics and Drug Development in the Neurological Institute, Cleveland
Clinic and Director of the Cleveland Clinic Lou Ruvo Center for Brain Health,
Las Vegas, Nevada and Cleveland, Ohio.
The Phase I clinical trial of ANAVEX 2-73 will be carried out
in collaboration with ABX-CRO and the University of Dresden in Germany.
Management will host a live investor conference call on
Wednesday, March 16, 2011 at 4:30pm ET to discuss the commencement of the ANAVEX
2-73 Phase I trial. Please call 1-877-653-3361 (toll free in the United States
and Canada) or +1 970-315-0801 and use conference ID 52335582 to
A recorded version of the call will be posted on our web site
shortly after the call.
About Alzheimer s Disease
While Alzheimer s disease is most common in people over the age
of 65, it can strike adults of any age irrespective of their gender, background
or socioeconomic status. According to the Alzheimer s Association an estimated
5.3 million Americans are currently living with Alzheimer s disease. The number
of Americans aged 65 and over with Alzheimer s is estimated to reach 7.7 million
in 2030. By 2050, between 11 million and 16 million Americans over 65 are
expected to have Alzheimer s disease.
ANAVEX 2-73 is the first of a new class of oral,
disease-modifying drugs being studied to potentially treat Alzheimer s disease
itself, versus treating its symptoms.
About Anavex Life Sciences Corp.
Anavex Life Sciences
Corp. (www.anavex.com) is a specialty pharmaceutical company engaged in the
discovery and development of novel drug candidates for the treatment of
neurological diseases and cancer. The Anavex proprietary SIGMACEPTOR Discovery
Platform involves the rational design of drug compounds targeted to specific
receptors involved in the modulation of multiple cellular biochemical signaling
The SIGMACEPTOR -N program involves the development of novel
drug candidates that target neurological and neurodegenerative diseases
(Alzheimer's disease, epilepsy, depression, pain). The company's lead drug
candidates exhibit high affinity for sigma receptors, which have been
extensively documented as potentially valuable drug targets and have
demonstrated anti-amnesic and neuroprotective properties.
Anavex is a publicly traded company under the symbol
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.
Forward-looking statements in this press release include that the Phase I trial
of ANAVEX 2-73 will commence immediately and that ANAVEX 2-73 is the first of a
new class of oral, disease-modifying drugs being studied to potentially treat
Alzheimer s disease itself, versus treating its symptoms. Actual events or
results may differ materially from those projected in any of such statements due
to various factors, including the risks and uncertainties inherent in drug
discovery and development, which include, without limitation, the potential
failure of development candidates to advance through preclinical studies or
demonstrate safety and efficacy in clinical testing and the ability to pass
clinical trials so as to move on to the next phase, our ability to retain key
employees and our ability to finance development or satisfy the rigorous
regulatory requirements for new drugs. 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
For Further Information
Anavex Life Sciences Corp.
Research & Business Development
Email: info@anavex.com
Shareholder & Media Relations
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com