Alzamend Neuro Partners With Biorasi to Conduct a First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase I/IIA Clinical Trial
Alzamend Neuro, Inc. (NASDAQ: ALZN) announced a partnership with Biorasi to conduct a Phase I/IIA clinical trial evaluating the safety, tolerability, and efficacy of ALZN002, an immunotherapy for mild-to-moderate Alzheimer's dementia. The trial will involve 20-30 subjects, with initial results expected to inform a larger Phase IIB trial within three months. ALZN002, a patient-specific therapy, utilizes autologous dendritic cells to target amyloid-beta proteins. The company aims to initiate the trial by March 2023, marking a significant step in Alzheimer’s treatment research.
- Partnership with Biorasi for conducting a Phase I/IIA clinical trial.
- ALZN002 is a patented immunotherapy aiming to treat mild-to-moderate Alzheimer's.
- Expected initiation of the trial by March 2023, with results to guide further studies.
- Patient-specific therapy utilizing autologous dendritic cells may enhance treatment effectiveness.
- Phase I/IIA trial's results remain uncertain, as this is the first human study.
Study to Assess the Safety, Tolerability, and Efficacy of Autologous Amyloid Beta Mutant Peptide-Pulsed Dendritic Cells (ALZN002) in Subjects With Mild-to-Moderate Dementia of the Alzheimer's Type
The purpose of this trial will be 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 dementia of the Alzheimer’s type. Also, the trial will be designed to determine the optimal dosage of ALZN002 for treatment of patients with Alzheimer’s in a larger Phase IIB efficacy and safety clinical trial (ALZN002-02), which Alzamend expects to initiate within three months of receiving data from the initial trial. ALZN002 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.
“Biorasi is a global, award-winning, full-service CRO with a plethora of experience with immunotherapeutic vaccines,” 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.
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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