Meets major clinical development milestone for lead compound
HOBOKEN, NJ, Dec. 21 /CNW/ - Anavex Life Sciences Corp. ("Anavex",
AVXL:OB) announced today that it has filed the regulatory submission
for ANAVEX 2-73 with the German Health Authority, BfArM, and the local
Ethics Committee of Saxony to begin clinical studies for ANAVEX 2-73,
its lead compound for the treatment of Alzheimer's disease.
"This regulatory filing marks an important milestone in the clinical
development path for ANAVEX 2-73 and our strategy to aggressively
complete a Phase I and IIa study in healthy human volunteers and
patients, respectively," said Dr. Cameron Durrant, Executive Chairman
of Anavex Life Sciences Corp.
Phase I dosing of healthy human volunteers with ANAVEX 2-73 is scheduled
to begin shortly. A Phase IIa study in patients with Alzheimer's and
Mild Cognitive Impairment may provide efficacy data as well as further
safety data and is currently scheduled to commence in mid 2011.
"Our extensive pre-clinical program for ANAVEX 2-73 and the data
generated so far offers the possibility of excellent safety and
tolerability and encouraging signs of potential efficacy," added Dr.
"The Phase I study will be comprised of a total of 24 healthy human
volunteers to allow us to test the maximally tolerated dose,
pharmacokinetics, pharmacodynamics, safety and bioavailability of
ANAVEX 2-73," said Dr. Angelos Stergiou, Clinical Research Physician
leading the program on behalf of Anavex and President of Genesis
The Phase I study will be carried out in collaboration with ABX-CRO and
the University of Dresden in Germany.
ANAVEX 2-73 is the first of a new class of compounds which act through
sigma-1 receptor agonism as well as muscarinic cholinergic effects and
modulation of endoplasmic reticulum stress thought to trigger a series
of intracellular effects which modify ion channel signaling at the
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (www.anavex.com) is a biopharmaceutical 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 pathways.
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 publically traded company under the symbol "AVXL".
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 we will complete a Phase I and IIa study in
healthy human volunteers and patients, that Phase I will commence
shortly and Phase IIa is currently scheduled to commence in mid 2011,
and that our drug compounds show potential promise to combat certain
diseases. 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. 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.
SOURCE Anavex Life Sciences Corp.
For further information:
Anavex Life Sciences Corp.
Research & Business Development
Shareholder & Media Relations
Outside North America: +1 (416) 489-0092