HOBOKEN, NJ, April 20 /CNW/ - Anavex Life Sciences Corp. ("Anavex")
(OTCBB: AVXL) today announced that the first healthy human volunteers
have been initially dosed in its Phase I clinical trial to evaluate
ANAVEX 2-73, the company's lead compound for Alzheimer's disease.
"We are pleased that the first volunteers have been dosed with the study
drug, according to the study protocol, and no adverse events have been
recorded post dosing to date," said Dr. Ozkan Yalkinoglou, Medical
Director of ABX-CRO.
"ANAVEX 2-73 is a proprietary, wholly owned drug that comes from a
family of compounds discovered and developed in-house. Its
first-in-human administration is the most significant and important
milestone in our corporate history. We eagerly anticipate the results
of this Phase I clinical trial," said Dr. Cameron Durrant, Executive
Chairman of Anavex.
"There is a significant need for new and effective oral treatments for
Alzheimer's disease. Based on several preclinical animal studies, we
believe ANAVEX 2-73 is a promising new anti-Alzheimer's compound that
has the potential to directly address the pathology of Alzheimer's
disease, potentially halting or even reversing its course," said Dr.
Angelos Stergiou, Vice President of Clinical Development & Medical
Affairs for Anavex.
The Phase I clinical trial is being conducted in Germany in
collaboration with ABX-CRO, which has conducted several Alzheimer's
disease studies, and the University of Dresden. Dosing of at least 16
healthy volunteers is expected to be complete in approximately three
About the ANAVEX 2-73 Phase I Clinical Trial
This Phase I clinical trial is a randomized, placebo-controlled study to
initially test ANAVEX 2-73 as a single, ascending oral dose in healthy
volunteers. The trial seeks to determine the maximum tolerated single
dose, safety, pharmacokinetics (the mechanisms of absorption and
distribution of the drug, the rate at which a drug begins to act and
the duration of its effect, as well as chemical changes of the
substance in the body) and pharmacodynamics (physiological effects of
drugs on the body, mechanisms of action and relationship between drug
concentration and effect).
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 5.4 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. This represents
a 50 percent increase from the 5.2 million Americans aged 65 and older
who are currently affected. The Alzheimer's Association further
projects that the number of Americans aged 65 and older who are
affected by Alzheimer's disease may triple to between 11 and 16 million
by 2050 unless there are developments to prevent or more effectively
treat the 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™ 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. A
portfolio of back-up compounds to ANAVEX 2-73 are also in development.
Anavex is a publicly 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 ANAVEX 2-73 is a promising new
anti-Alzheimer's compound that has the potential to directly address
the pathology of Alzheimer's disease, potentially halting or even
reversing its course, that dosing of at least 16 healthy volunteers is
expected to be complete in approximately three months and that ANAVEX
2-73 is the first of a new class of oral, disease-modifying drugs which
could potentially treat Alzheimer's disease. 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. Competitors may develop better or cheaper alternatives to
our products. 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