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
Alzamend Neuro, Inc. (Nasdaq: ALZN) has initiated a Phase I/IIA clinical trial for its immunotherapy vaccine ALZN002, aimed at treating mild to moderate Alzheimer's dementia. The trial seeks to evaluate the safety, tolerability, and efficacy of ALZN002 against a placebo, involving 20-30 subjects. The primary objective is to identify the suitable dosage for a larger Phase IIB trial, planned to launch within three months post-data collection. ALZN002, derived from patients' immune cells, targets amyloid-beta proteins associated with Alzheimer's, potentially offering a safer, less frequent treatment method. Pre-clinical studies show promising results with no adverse effects reported.
- Initiation of Phase I/IIA clinical trial for ALZN002, targeting Alzheimer's treatment.
- Positive results from pre-clinical studies indicating safety and efficacy of ALZN002.
- Proprietary active immunotherapy approach tailored to individual patients, potentially reducing treatment frequency.
- None.
“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
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
About
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
Forward-Looking Statements
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Email: Info@Alzamend.com or call: 1-844-722-6333
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FAQ
What is the purpose of the ALZN002 clinical trial initiated by Alzamend Neuro?
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