VANCOUVER, March 18, 2013 /PRNewswire/- Anavex Life Sciences Corp. ("Anavex") (OTCQB: AVXL) today commented on
the United States Food and Drug Administration's (FDA) plan to expedite
the approval of new treatments for Alzheimer's disease. As reported by
the New York Times, drugs in clinical trials would qualify for approval if people with
very early-stage Alzheimer's showed even subtle improvement in memory
or reasoning tests. ANAVEX 2-73, the company's lead compound for
Alzheimer's disease, has successfully completed a Phase 1 clinical
trial in humans.
"Anavex strongly supports this proposal to accelerate the approval of
drugs that could slow down or prevent Alzheimer's disease," said Tom
Skarpelos, director of Anavex. "This FDA proposal has the potential to
help tens of millions of Americans, including those at risk of
developing the devastating disease and those in the early stages, when
disease-modifying medications would be extremely useful."
Data from the ANAVEX 2-73 Phase 1 human clinical trial indicates that
the drug is well tolerated with no dose-limiting toxicities unrelated
to the drug's mechanism of action. World-renowned Alzheimer's
scientists have published studies showing that ANAVEX 2-73 protects
neurons to prevent cell death and reverses symptoms of the disease in
mouse models. Pre-clinical animal studies showed early signs of
efficacy, improvement in the memory of animals and, in some cases, a
The FDA has approved only five drugs for the treatment of Alzheimer's
disease. Each of these drugs is symptomatic, meaning they treat
symptoms, rather than the disease itself. They do not have the ability
to stop the onset or progression of Alzheimer's disease.
ANAVEX 2-73 was developed to treat Alzheimer's through a mechanism of
action that modifies the disease, rather than temporarily addressing
symptoms of the disease.
"We are excited by the potential of ANAVEX 2-73 to help conquer
Alzheimer's disease," added Mr. Skarpelos. "The data generated to date
supports our approach to potentially prevent, halt and/or reverse the
course of Alzheimer's disease."
The FDA proposal was published in the New England Journal of Medicine on March 13, 2013.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (www.anavex.com) is a pharmaceutical company engaged in the development of novel drug
candidates. ANAVEX 2-73, a drug candidate developed to treat
Alzheimer's disease through disease modification, has undergone an
initial Phase 1 human clinical trial and was well tolerated in doses up
to 55mg. Sponsored pre-clinical studies indicate that ANAVEX 2-73
demonstrates anti-amnesic and neuroprotective properties. Anavex is a
publicly traded corporation quoted as 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. 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 finance development or satisfy the rigorous
regulatory requirements for new drugs, our ability to attract and
retain quality personnel, and that despite positive results, our
competitors may offer better or cheaper alternatives. 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.
Anavex Life Sciences Corp.
Research & Business Development
Shareholder & Media Relations
Outside North America: +1 (416) 489-0092
SOURCE Anavex Life Sciences Corp.