Alzamend Neuro Receives Positive Pre-IND Response from FDA for AL002, a Cell-Based Therapeutic Vaccine That Seeks to Restore the Ability of Patients’ Immunological System to Combat Alzheimer’s Disease
September 30 2021 - 10:11AM
Business Wire
FDA Agrees to Alzamend’s Plan to Conduct a Combined Phase 1 and
2 Clinical Trial for AL002
Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an
early clinical-stage biopharmaceutical company focused on
developing novel products for the treatment of neurodegenerative
diseases and psychiatric disorders, today announced that it has
received a written response to its meeting request relating to its
Type B Pre‑Investigational New Drug (“IND”) application from
the U.S. Food and Drug Administration (the “FDA”) providing
a path for Alzamend’s planned clinical development of AL002. 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.
“We appreciate the thorough and meaningful response from the
FDA, which provides us with the information and clarity needed to
submit the IND application to initiate a clinical trial for AL002,”
said Stephan Jackman, Alzamend’s Chief Executive Officer.
“Preclinical work supports AL002 being associated with a positive
anti-inflammatory response and a decrease in brain amyloid
contents. Based on AL002’s positive toxicology results, the
biologic nature of this product and the urgent need to deliver
treatments for Alzheimer’s to patients, Alzamend proposed, and the
FDA agreed, to conduct a combined Phase 1/2 study. We appreciate
the FDA’s recommendations, guidance and other helpful advice. We
plan to augment our proposed clinical trial protocols and proceed
accordingly.”
Based on the FDA’s written feedback, Alzamend anticipates filing
the IND by the end of November 2021 and initiating the clinical
trial of AL002 in the first quarter of 2022.
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 that subsequently block the
neurological brain signals, ultimately leading to the symptoms and
onset of Alzheimer’s.
About Alzamend Neuro
We are early clinical stage biopharmaceutical company focused on
developing novel products for the treatment of neurodegenerative
diseases and psychiatric disorders, including Alzheimer’s. 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 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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