Anavex completes successful preclinical studies on lead Alzheimer`s drug candidate

Released on: September 2, 2008, 7:08 am

Press Release Author: ANAVEX Life Sciences Corp.

Industry: Pharmaceuticals

Press Release Summary: Anavex completes successful preclinical studies on ANAVEX
2-73, a novel sigma-1 receptor agonist for the treatment of Alzheimer\'s disease.

Press Release Body: ATHENS, GREECE, Sept. 2 - Anavex Life Sciences Corp. (\"ANAVEX\")
(OTCBB: AVXL), a biopharmaceutical company engaged in the discovery and development
of novel therapeutics to treat Central Nervous System (CNS) diseases and cancer,
today announced the successful completion of preclinical studies (in-vitro and
in-vivo in mice) on ANAVEX 2-73, a novel sigma-1 receptor agonist for the treatment
of Alzheimer\'s disease. This success enables ANAVEX to start preparing the
Investigational New Drug (IND) (or IMPD) file to move to Phase 1 human clinical
trials.
\"The completion of preclinical studies is a key milestone for our company, and means
that we are now ready to prepare our first IND for Alzheimer\'s disease and move
towards human trials,\" said Harvey Lalach, President of ANAVEX. \"Our novel approach
is based on ANAVEX\'s expertise and leadership in the field of sigma receptors and
our highly productive drug discovery platform. This approach has made it possible
for us to develop the first in a series of novel, new-generation drugs using sigma
ligands to treat a range of CNS and oncological conditions. We are excited to be
advancing this first novel compound for Alzheimer\'s disease toward clinical trials.\"
In preparation for an IND/IMPD filing, ANAVEX is engaging an expert Contract
Research Organization (CRO) to perform final toxicity, pharmacokinetic,
pharmacodynamic and metabolism studies in various animal species. Thereafter the IND
(or IMPD) file will be submitted to the FDA (or the EMEA respectively) for approval
in order to start Phase 1 clinical trials targeted for the first half of 2009.
ANAVEX 2-73 is a novel tetrahydrofuran that exhibits high affinity and selectivity
to sigma-1 receptors and synergistic action with muscarinic receptors. Additional
beneficial effects have been demonstrated on NMDA receptors. During preclinical
studies (in-vitro and in-vivo in mice), ANAVEX 2-73 demonstrated significant
neuroprotective, anti-amnesic and anti-convulsive properties. It also exhibited an
excellent safety profile and therapeutic activity at very low doses.
ANAVEX 2-73 has been shown to provide protection from oxidative stress, which
damages and destroys neurons and is believed to be a primary cause of Alzheimer\'s
disease. Research in recent years indicates that oxidative stress is a precursor to
amyloid-beta plaques and tau (Neuro-Fibrillary Tangles or NFT) and, as such, is the
appropriate therapeutic target. ANAVEX 2-73 is not focused on reducing or dissolving
amyloid-beta protein, unlike drug candidates from other biopharmaceutical companies
that have recently produced disappointing clinical results.
Preclinical studies on ANAVEX 1-41, another lead compound targeting Alzheimer\'s
disease and depression, are scheduled for completion in Q4 2008.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (www.anavex.com) is an emerging biopharmaceutical company
engaged in the discovery and development of novel drug targets for the treatment of
cancer and neurological diseases such as Alzheimer\'s, epilepsy and depression. The
company\'s proprietary SIGMACEPTOR(tm) Discovery Platform involves the rational
design of drug compounds that fulfill specific criteria based on unmet market needs
and new scientific advances. Selected drug candidates demonstrate high,
non-exclusive affinity for sigma receptors, which are involved in the modulation of
multiple cellular biochemical signaling pathways.


ANAVEX\'s SIGMACEPTOR(tm)-N program involves the development of novel and original
drug candidates that target neurological and neurodegenerative diseases (Alzheimer\'s
disease, epilepsy, depression, pain). The company\'s lead drug candidates exhibit
high, non-exclusive affinity for sigma receptors with strong evidence for
anti-amnesic, neuroprotective, anti-apoptotic, anti-oxidative, anti-inflammatory,
anti-convulsive, anti-depressant and anxiolytic properties. The company believes
that oxidative stress, not amyloid-beta, is the cause of Alzheimer\'s. ANAVEX 1-41,
uses sigma receptors, a unique class of receptor molecules, to guard against
oxidative stress and repair cells compromised by its effects. So far, through the
advanced pre-clinical phase of development, the compound has performed extremely
well in well-recognized animal models of Alzheimer\'s disease, underscoring the
promise of this alternative approach to the disease.
ANAVEX SIGMACEPTOR(tm)-C program involves the development of novel and original drug
candidates targeting cancer. The company\'s lead drug candidates exhibit high,
non-exclusive affinity for sigma receptors with strong evidence for selective
pro-apoptotic, anti-metastatic and low toxicity properties in various types of solid
cancers such as colon, prostate, breast and lung. ANAVEX 7-1037 has already
demonstrated its ability to significantly delay the growth of cancerous tumors in
patient-derived xenografts during advanced pre-clinical studies.
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 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 file an IND
or commence clinical studies. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. This caution is
made under the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. 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.






Web Site: http://www.anavex.com

Contact Details: 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

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