Full Press Release Details
Anavex rapidly advances ANAVEX 2-73 for Alzheimer s disease,
Phase I clinical trial progressing well
Hoboken, NJ July 6, 2011 -- Anavex Life Sciences Corp.
( Anavex ) (OTCBB: AVXL) has commenced the 30 mg dose step in its ongoing Phase
I clinical trial to evaluate ANAVEX 2-73, the company s lead drug candidate for
Alzheimer s disease. This is the third of six potential dose steps and follows
the successful completion of the 1 mg and 10 mg dosing rounds. There have been
no adverse effects recorded after the administration of ANAVEX 2-73 at the doses
Trial participants are receiving single, ascending oral doses
of ANAVEX 2-73 with one group potentially advancing to a maximum single oral
dose of 240 mg. To that end, the ANAVEX 2-73 Phase I trial is rapidly and
positively advancing.
Positive safety data at lower doses has so far enabled the
company to skip one higher dosing step and increase the amount being
administered by ten times, from 1 mg to 10 mg, instead of from 1mg to 5mg. This
recommendation was unanimously recommended by the Safety Review Committee for
ANAVEX 2-73 following their evaluation of the available safety data from the
first group of healthy human volunteers in the initial dose step.
After each dose step, the Safety Review Committee meets to
discuss the safety data in a blinded manner and determine whether the next
higher dose should be administered. The committee bases its decision on clinical
safety and tolerability data and on laboratory and available pharmacokinetic
data (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) from the preceding dose step(s). In
addition, each volunteer is contacted by phone for a further safety check on day
seven following drug administration. Preclinical data is also considered.
Data from the Phase I trial is expected to build upon the
excellent safety profile of ANAVEX 2-73 in preclinical studies conducted with
mice, rats and dogs. In addition to a favorable safety profile to date,
preclinical studies of ANAVEX 2-73 have already generated evidence of improving
and reversing the memory and learning deficits in animal models which may mimic
the effects of Alzheimer s disease. Specifically, there is evidence of
neuroprotection -- in other words certain brain cells that are ordinarily lost
in these animal models are preserved.
The primary objective of the Phase I clinical trial is to
evaluate the safety and tolerability of ANAVEX 2-73 in humans for the first
time. The secondary objective of the Phase I trial is to determine the
pharmacokinetic profile of single oral ascending doses of ANAVEX 2-73.
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
male volunteers between the ages of 18 and 55. The trial seeks to determine the
maximum tolerated single dose, safety and pharmacokinetics.
The Phase I clinical trial is being 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.
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
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.
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 ANAVEX 2-73 Phase I trial is rapidly and positively advancing, that
data from the Phase I trial is expected to build upon the excellent safety
profile of ANAVEX 2-73, 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. 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
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