Alzamend Neuro Receives Positive Results for AL002 in a GLP Toxicology Study Using a Transgenic Mouse Model of Alzheimer’s Disease
July 23 2021 - 6:30AM
Business Wire
AL002 is a Patented Method Using a Mutant-Peptide Sensitized
Cell as a Cell-Based Therapeutic Vaccine
Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a
preclinical stage biopharmaceutical company focused on developing
novel products for the treatment of neurodegenerative diseases and
psychiatric disorders, today announced that it has received
positive toxicology results for AL002 in a good laboratory
practices (“GLP”) toxicology study using a transgenic mouse
model of Alzheimer’s disease. The study was conducted by Charles
River Laboratories. AL002 is a patented method using a
mutant-peptide sensitized cell as a cell-based therapeutic vaccine
that seeks to restore the ability of a patient’s immunological
system to combat Alzheimer’s.
“The positive GLP toxicology results represent a key milestone
for Alzamend as we continue to advance our proprietary pipeline. We
believe AL002 could potentially reverse the effects of Alzheimer’s
disease. We look forward to providing more details on the timeline
and market opportunity as we prepare for the submission of our
Pre-Investigational New Drug Application for AL002 to the U.S. Food
and Drug Administration in the near future,” commented Stephan
Jackman, the Chief Executive Officer of Alzamend.
Overview of the GLP toxicology study
A five-dose GLP study with AL002-sensitized cells was completed
using a transgenic (or genetically modified) mouse model of
Alzheimer’s disease to investigate the tolerability of AL002.
Single injections were administered on days 1, 30, 50, 70, and 90.
The mice were evaluated for potential toxicity and reversibility of
any findings at 75 and 90 days after dosing.
Histopathology results demonstrate that there was no indication
of T-cell infiltration or meningoencephalitis suggesting that AL002
therapy is safe and tolerable as there were no adverse findings
over a 90-day period and 90 days after the last dose. There were no
treatment-related mortalities or reports of adverse effects on
clinical observations, body weight parameters, organ weight
parameters, clinical pathology parameters, gross pathology
observations, or histopathologic observations during the main study
or the recovery phase.
About AL002
AL002 is a patented method using a mutant-peptide sensitized
cell as a cell-based therapeutic vaccine that reduces beta-amyloid
plaque and seeks to restore the ability of the patient’s
immunological system to combat Alzheimer’s disease. This therapy is
intended to work by stimulating the body’s own immune system to
prevent the formation and breakdown of beta amyloids, which build
up in the brain to form a plaque and subsequently block the
neurological brain signals, ultimately leading to the symptoms and
onset of Alzheimer’s.
About Alzamend Neuro
We are a preclinical stage biopharmaceutical company focused on
developing novel products for the treatment of neurodegenerative
diseases and psychiatric disorders, including Alzheimer’s disease.
With our product candidates, we aim to bring treatments or cures to
market at a reasonable cost as quickly as possible. Our current
pipeline consists of two novel therapeutic drug candidates, AL001 -
a patented ionic cocrystal technology delivering a therapeutic
combination of lithium, proline and salicylate, and AL002 - a
patented method using a mutant-peptide sensitized cell as a
cell-based therapeutic vaccine that seeks to restore the ability of
a patient’s immunological system to combat Alzheimer’s. Both of our
product candidates are licensed from the University of South
Florida Research Foundation, Inc. pursuant to royalty-bearing
exclusive worldwide licenses.
Forward-Looking Statements
This press release contains “forward looking statements” within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These forward-looking statements generally include
statements that are predictive in nature and depend upon or refer
to future events or conditions, and include words such as
“believes,” “plans,” “anticipates,” “projects,” “estimates,”
“expects,” “intends,” “strategy,” “future,” “opportunity,” “may,”
“will,” “should,” “could,” “potential,” or similar expressions.
Statements that are not historical facts are forward-looking
statements. Forward-looking statements are based on current beliefs
and assumptions that are subject to risks and uncertainties.
Forward-looking statements speak only as of the date they are made,
and Alzamend undertakes no obligation to update any of them
publicly in light of new information or future events. Actual
results could differ materially from those contained in any
forward-looking statement as a result of various factors. More
information, including potential risk factors, that could affect
Alzamend’s business and financial results are included in
Alzamend’s filings with the U.S. Securities and Exchange
Commission. All filings are available at www.sec.gov and on
Alzamend’s website at www.Alzamend.com.
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