HOBOKEN, NJ, Nov. 14, 2011 /CNW/ - Anavex Life Sciences Corp. ("Anavex")
(OTCBB: AVXL) today announced the successful completion of its Phase 1
single ascending dose (SAD) clinical trial of ANAVEX 2-73, the
company's lead drug candidate for the treatment of Alzheimer's Disease
(AD). ANAVEX 2-73 is the first of a new class of oral drugs being
studied to potentially treat AD through disease modification rather
than focusing only on symptomatic improvement.
In this Phase 1 SAD study, the maximum tolerated single dose was defined
per protocol as 55-60 mg. This dose is above the equivalent dose shown
to have positive effects in mouse models of AD. There were no
significant changes in laboratory or electrocardiogram (ECG)
parameters. ANAVEX 2-73 was well tolerated below the 55-60 mg dose with
only mild adverse events in some volunteers. Observed adverse events
at doses above the maximum tolerated single dose included headache and
dizziness, which were moderate in severity and reversible. These side
effects are often seen with drugs that target central nervous system
(CNS) conditions, including AD.
"With the successful completion of this trial, we will immediately begin
a multiple ascending dose trial," said Dr. George Tidmarsh, MD, PhD,
Executive Director of Anavex. "Further analysis of the data is ongoing
and we look forward to announcing complete results later this year.
These Phase 1 studies take us an important step closer to Phase 2
trials in patients with Alzheimer's Disease."
"Targeting the sigma-1 receptor represents a novel therapeutic avenue
with potential for the treatment of Alzheimer's Disease. I welcome new
treatment approaches to this devastating disease," 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 ANAVEX 2-73 Phase 1 trial was conducted as a randomized,
placebo-controlled study. Healthy male volunteers between the ages of
18 and 55 received single, ascending oral doses over the course of the
trial. Study endpoints included safety and tolerability together with
pharmacokinetic parameters. Pharmacokinetics includes the absorption
and distribution of a drug, the rate at which a drug enters the blood
and the duration of its effect, as well as chemical changes of the
substance in the body. This study was conducted in Germany in
collaboration with ABX-CRO, a clinical research organization that has
conducted several Alzheimer's Disease studies, and the Technical
University of Dresden.
Drug development of novel compounds prior to marketing authorization
involves Phase 1 single and multiple ascending dose studies prior to
initiating Phase 2 studies. Phase 2 studies are intended to further
assess the safety of the compound as well provide an initial evaluation
of activity. Phase 3 trials involve a much larger number of patients
and are designed to demonstrate clinical efficacy and further define
the safety profile of the compound.
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 double or triple to between 11 and
16 million by 2050 unless there are developments to prevent or more
effectively treat the disease.
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 the first of a new class of
oral drugs being studied to potentially treat Alzheimer's through
disease modification, that targeting the sigma-1 receptor represents a
novel therapeutic avenue with potential for the treatment of
Alzheimer's Disease, and that we will be announcing complete results
later this year. 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