Anavex Life Sciences Reports Potential Normalization of Hypertension with ANAVEX®2-73 Published in The Journal of Clinical H...
January 16 2018 - 7:00AM
Anavex Life Sciences Corp. (“Anavex” or the “Company”)
(Nasdaq:AVXL), a clinical-stage biopharmaceutical company
developing differentiated therapeutics for the treatment of
neurodegenerative and neurodevelopmental diseases today reports
that the peer-reviewed scientific journal The Journal of Clinical
Hypertension [1] has published a post-hoc analysis of blood
pressure data collected during the Phase 2a study in
mild-to-moderate Alzheimer’s disease patients demonstrating that
ANAVEX®2-73 seems to normalize systolic blood pressure (SBP) in a
patient population with risk for hypertension.
Statistical analyses including paired t-testing and
multivariable linear mixed effects modeling (adjusted for time of
measurement, gender, age, body mass index, and use of
antihypertensives) indicate a normalization of SBP from the first
reading (baseline) of 143.3 mmHg to the subsequent readings after
ANAVEX®2-73 administration of 132.5 mmHg (p=0.048) at day 25 and of
135.3 mmHg (p=0.008) at day 36, respectively.
High blood pressure, or hypertension, occurs when either
systolic or diastolic pressure remains elevated over time. High
blood pressure is dangerous because it makes the heart work too
hard and its extra force can damage arteries. Uncontrolled high
blood pressure can lead to heart disease, kidney damage or stroke.
New evidence also links high blood pressure to increased risk of
cognitive decline and dementia. [2]
Thirty-two mild-to-moderate Alzheimer’s disease patients took
part in the ANAVEX2-73 Phase 2a study. Mean age was 69.5 years, 60%
were male, mean body mass index was 26.5 kg/m2, and 50% were on
antihypertensive medication. No patients reported any changes in
their antihypertensive regimen while taking part in the study.
Raymond R. Townsend, MD, Professor of Medicine and Director of
the Hypertension Program at the Hospital of the University of
Pennsylvania, the senior author of the paper, notes “Intriguingly,
systolic blood pressure was selectively normalized, the mediation
of which is key in reducing the likelihood of heart attack, stroke
and other cardiovascular issues in older patients.”
“The systolic blood pressure findings may be quite clinically
meaningful. There are properties of the medication that support a
compelling mechanism for how it can lower high blood pressure,”
states Jordana B. Cohen, MD, MSCE, Instructor of Medicine in the
Renal-Electrolyte and Hypertension Division at the University of
Pennsylvania and lead author of the paper. “Nonetheless, given that
the Phase 2a study was not designed to measure changes in blood
pressure over time, the results require further corroboration.”
“While in a previously reported Phase 1 study ANAVEX2-73 did not
affect blood pressure in healthy subjects, who demonstrated normal
blood pressure levels at baseline, the results of the post-hoc
analysis of the Phase 2a study in mild-to-moderate Alzheimer’s
disease patients with majority of patients with elevated blood
pressure, warrant cautious interpretation. Blood pressure
measurement was not a primary goal of this trial, however, the
potential beneficial effect of sigma-1 receptor activation
restoring homeostasis on blood pressure normalization merits
further investigation in future clinical studies,” stated
Christopher U. Missling, PhD, President and Chief Executive Officer
of Anavex.
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, recently
completed a successful a Phase 2a clinical trial for Alzheimer’s
disease. ANAVEX®2-73 is an orally available drug candidate that
restores cellular homeostasis by targeting sigma-1 and muscarinic
receptors. 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.
The Michael J. Fox Foundation for Parkinson’s Research has awarded
Anavex a research grant to develop ANAVEX®2-73 for the treatment of
Parkinson’s disease. The grant fully funds 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. You can
also connect with the company
on Twitter, Facebook and LinkedIn.
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 & Media:
Clayton Robertson The Trout Group (646) 378-2900
crobertson@troutgroup.com
[1] Cohen J1, Perlis M2, Townsend R1, Systolic Blood
Pressure as a Potential Target of Sigma-1 Receptor Agonist
Therapy, The Journal of Clinical Hypertension. 2018
January 15
1Renal-Electrolyte and Hypertension Division, Perelman School of
Medicine, University of Pennsylvania, Philadelphia, PA2Department
of Psychiatry, Perelman School of Medicine, University of
Pennsylvania, Philadelphia, PA, Michael Perlis, PhD is a consultant
for Anavex Life Sciences
[2] https://www.alz.org/we_can_help_blood_pressure.asp
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