Alzamend Neuro Announces the Initiation of a Phase I/IIA Trial for Its Immunotherapy Vaccine (ALZN002) to Treat Mild to Moderate Dementia of the Alzheimer’s Type
03 Abril 2023 - 7:50AM
Business Wire
Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early
clinical-stage biopharmaceutical company focused on developing
novel products for the treatment of Alzheimer’s disease
(“Alzheimer’s”), bipolar disorder, major depressive disorder
(“MDD”) and post-traumatic stress disorder (“PTSD”), today
announced the initiation of a phase I/IIA clinical trial for its
immunotherapy vaccine (ALZN002) to treat mild to moderate dementia
of the Alzheimer’s type. The purpose of this trial is to assess the
safety, tolerability, and efficacy of multiple ascending doses of
ALZN002 compared with that of placebo in 20-30 subjects with mild
to moderate morbidity. The primary goal of this clinical trial is
to determine an appropriate dose of ALZN002 for treatment of
patients with Alzheimer’s in a larger Phase IIB efficacy and safety
clinical trial, which Alzamend expects to initiate within three
months of receiving data from the initial trial.
“Alzamend’s motto is ‘Making Alzheimer’s just a memory.’ There
remains a need to develop new therapies that alter the progression
of Alzheimer’s and prevent, reverse or slow neurodegeneration and
cognitive decline. Today, we are on the threshold of importantly
advancing the art and science of anti-beta amyloid therapy by
treating each Alzheimer’s patient’s individual immune system,” said
Stephan Jackman, Chief Executive Officer of Alzamend. “Intermittent
use of our immunotherapeutic vaccine (ALZN002) may be expected to
limit the number of infusions needed, may reduce the potential for
adverse reactions, and provide more substantive cognitive and
functional outcomes to the millions of Americans afflicted with
this devastating disease.”
About ALZN002
ALZN002 is a proprietary “active” immunotherapy product, which
means it is produced by each patient’s immune system. It consists
of autologous dendritic cells (“DCs”), which are activated white
blood cells taken from each individual patient that are then
engineered outside of the body to attack Alzheimer’s-related
amyloid-beta proteins. These DCs are pulsed with a novel
amyloid-beta peptide (E22W) designed to bolster the ability of the
patient’s immune system to combat Alzheimer’s; the goal of this
treatment approach is to foster tolerance to treatment for safety
purposes while stimulating the immune system to reduce the brain’s
beta-amyloid protein burden, resulting in reduced Alzheimer’s signs
and symptoms.
The ALZN002 DC treatment is, by definition, an
individual-patient-specific therapy since these autologous DCs are
administered to the same patient from whom they were removed. Each
patient will undergo leukapheresis, i.e., removal and return to the
body of white blood cells. This procedure will isolate each
patient’s peripheral blood monocytes from the obtained white blood
cells. These are subsequently differentiated outside the body into
DCs that are engineered to induce immunogenicity (search and
destroy capability) towards amyloid, the protein associated with
Alzheimer’s in the patient’s body, but to be otherwise tolerated as
natural to the body to avoid adverse side effects.
Compared to passive immunization treatment approaches that use
foreign blood products (such as monoclonal antibodies), active
immunization with ALZN002 is anticipated to offer a more robust and
long-lasting effect on the clearance of amyloid. This is expected
to provide a safe and effective treatment for Alzheimer’s sufferers
that requires considerably less frequent treatment visits compared
to passive immunity approaches.
Multiple pre-clinical studies have been conducted using a
transgenic (or genetically modified) mouse model of Alzheimer’s
disease at the University of South Florida and Charles River
Laboratories that reported encouraging Alzheimer’s disease-related
measurements and neurobehavioral effects, supporting this IND
application. Strong evidence of significant ALZN002‑mediated
amyloid plaque reductions was observed in mouse disease models.
There were no undue adverse findings in a good laboratory practices
toxicology study, which consisted of five injections administered
over a 90-day period and evaluated for 90 days after the last dose.
Histopathology results demonstrated that there were no indication
of T-cell infiltration or meningoencephalitis (inflammation of the
membranes that surround the brain), suggesting that ALZN002 is safe
and tolerable. In addition, there were no treatment-related
mortalities or reports of adverse effects on clinical observations
during the main study or the recovery phase.
About Alzamend Neuro
Alzamend is an early clinical-stage biopharmaceutical company
focused on developing novel products for the treatment of
Alzheimer’s, bipolar disorder, MDD and PTSD. Our mission is to
rapidly develop and market safe and effective treatments. Our
current pipeline consists of two novel therapeutic drug candidates,
AL001 - a patented ionic cocrystal technology delivering lithium
via a therapeutic combination of lithium, proline and salicylate,
and ALZN002 - 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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