Anavex Confirms Data from Phase 2a Study of ANAVEX 2-73 in Alzheimer’s Patients Presented at AAIC 2016
July 29 2016 - 9:20AM
Anavex Life Sciences Corp. (“Anavex” or the “Company”)
(Nasdaq:AVXL), confirms the information in the July 27, 2016 press
release announcing positive results from the Phase 2a Alzheimer’s
trial for ANAVEX 2-73.
Dr. Norman Relkin, MD, PhD, an Alzheimer
clinical trialist and an advisor to Anavex, commented: “To
interpret the ANAVEX 2-73 results presented at the 2016 AAIC
meeting, it is important to keep in mind the stated goals of this
first in Alzheimer’s patients study. This was a Phase 2a
study, primarily designed to determine which ANAVEX 2-73 dosages
are safe to administer to mild to moderate stage Alzheimer’s
patients. The study was successful in establishing the
maximum tolerated dose and in revealing the range of ANAVEX 2-73
doses that are well-tolerated by Alzheimer patients. It also
provided encouraging evidence that previously reported positive
trends in certain cognitive and biologic measures persisted over a
period of approximately 31 weeks. However, this analysis was
based on pooled data from a relatively small number of subjects
receiving a variety of doses. It is therefore unlikely that
these findings reflect the full potential ANAVEX 2-73 in treating
Alzheimer’s disease. It is unreasonable to draw conclusions
about any limits to the long-term efficacy of ANAVEX 2-73 based on
the interim Phase 2a findings, especially since no statistically
significant decline from baseline was reported, which is
impressive. Detailed pre-planned analysis of the
pharmacodynamic results is in progress, which is one of the key
factors of relevance for regulatory agencies and which will also
determine the optimal dose for future studies.“
Anavex confirms that there has been no change
with regards to its science, data or the fundamentals of the
Company. Anavex remains dedicated to advancing ANAVEX 2-73 and will
be reporting new data to investors as it becomes available.
Anavex confirms the data included in its news
release dated July 27, 2016.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq:AVXL) is a
publicly traded biopharmaceutical company dedicated to the
development of differentiated therapeutics for the treatment of
neurodegenerative and neurodevelopmental diseases including
Alzheimer’s disease, other central nervous system (CNS) diseases,
pain and various types of cancer. Anavex’s lead drug candidate,
ANAVEX 2-73, is currently in a Phase 2a clinical trial for
Alzheimer’s disease. ANAVEX 2-73 is an orally available drug
candidate that targets sigma-1 and muscarinic receptors and
successfully completed Phase 1 with a clean safety profile.
Preclinical studies demonstrated its potential to halt and/or
reverse the course of Alzheimer’s disease. It has also exhibited
anticonvulsant, anti-amnesic, neuroprotective and anti-depressant
properties in animal models, indicating its potential to treat
additional CNS disorders, including epilepsy and others. The
Michael J. Fox Foundation (MJFF) for Parkinson’s Research has
awarded Anavex a research grant to develop ANAVEX 2-73 for the
treatment of Parkinson’s disease to fully fund a preclinical study,
which could justify moving ANAVEX 2-73 into a Parkinson’s disease
clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1
muscarinic receptors, is a promising preclinical drug candidate
demonstrating disease modifications against the major Alzheimer’s
hallmarks in transgenic (3xTg-AD) mice, including cognitive
deficits, amyloid and tau pathologies, and also with beneficial
effects on neuroinflammation and mitochondrial dysfunctions.
Further information is available at www.anavex.com.
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.
Actual events or results may differ materially from those projected
in any of such statements due to various factors, including the
risks set forth in the Company’s most recent Annual Report on Form
10-K filed with the SEC. 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.
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Matthew Haines
River East Investor Relations, LLC
917-733-9297
mhaines@rivereastir.com
Media:
Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com
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