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ANAVEX RECEIVES APPROVAL TO COMMENCE PHASE I CLINICAL TRIAL IN ALZHEIMER’S DISEASE

March 15, 2011
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ANAVEX 2-73 trial to be initiated immediately in Germany

HOBOKEN, NJ, March 15 /PRNewswire-FirstCall/ – 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 Anavex.

“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.

Conference Call

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
participate. 

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.

About ANAVEX 2-73

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(TM) Discovery
Platform involves the rational design of drug compounds targeted to
specific receptors involved in the modulation of multiple cellular
biochemical signaling pathways.

The SIGMACEPTOR(TM)-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 “AVXL”.

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 date hereof.

Anavex Life Sciences Corp.
Research & Business Development
Email: info@anavex.com

Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com

SOURCE Anavex Life Sciences Corp.


Source: newswire