HOBOKEN, NJ, May 23, 2011 /CNW/ - Anavex Life Sciences Corp. ("Anavex")
(OTCBB: AVXL) is pleased to provide an update on its ongoing Phase I
clinical trial to evaluate ANAVEX 2-73, the company's lead candidate
for Alzheimer's disease. After reviewing all the safety data from the
first group of healthy human volunteers in the initial dose step, the
Safety Review Committee for ANAVEX 2-73 unanimously approved skipping
the 5 mg dose and moving directly to the 10 mg dose step. The next
group of eight healthy volunteers was dosed late last week. The
clinical trial protocol allowed for the next dose to be studied as
either 5 mg or 10 mg, if the safety review warranted the higher dose.
"We are very pleased with the clinical trial data results to date for
the safety profile of ANAVEX 2-73," said Dr. Angelos Stergiou, Vice
President of Clinical Development and Medical Affairs for Anavex. "Our
Safety Review Committee meets regularly to discuss and review the
clinical trial data in a blinded manner. Following an extensive review
of the current results, the Safety Review Committee was confident in
allowing us to move directly into the 10 mg dose step."
"I am honored to be the Principal Investigator and a member of the
Safety Review Committee for this potential disease-modifying drug,
ANAVEX 2-73, in Alzheimer's disease. The healthy volunteers to date
have been successfully dosed according to the study protocol at the
Technical University of Dresden and there has been no evidence at all
to date of any treatment-related adverse effects. Our Safety Review
Committee has reviewed and discussed all data in detail and agreed to
proceed to the 10 mg dose stage. With such promising preclinical data I
am hopeful that we can continue to advance ANAVEX 2-73 through its
development path," said PD Dr. Christoph Schindler, MD, of the
Technical University of Dresden.
The Safety Review Committee is comprised of the following members: PD
Dr. Christoph Schindler, Clinical Pharmacologist and Principal
Investigator for the ANAVEX 2-73 Phase I clinical trial at the Medical
Faculty of the Technical University of Dresden, Dr. Juergen Wurziger,
MD, the study physician on behalf of ABX-CRO, the Clinical Research
Organization running the trial, and Dr. Angelos Stergiou, MD, the
responsible study physician for Anavex Life Sciences.
To make its decision, the Safety Review Committee assessed all of the
following safety data to date in a blinded manner:
Laboratory reports of safety data as described in the protocol up to 48
hours (day three) after dosing
Electrocardiograph (ECG) and vital data as described in the protocol up
to 48 hours (day three) after dosing
A summary on any adverse events that occurred in this dosing group
Each volunteer is contacted by phone for a further safety check on day
seven following drug administration
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 Technical University of Dresden. Dosing of at
least 16 healthy human volunteers is expected to be completed in
approximately two months as per the trial protocol.
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).
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 dosing of at least 16 healthy human
volunteers is expected to be completed in approximately two months as
per the trial protocol, that ANAVEX 2-73 is the first of a new class of
oral, disease-modifying drugs which could potentially treat Alzheimer's
disease and that we can continue to advance ANAVEX 2-73 through its
development path. 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