ALZN002 / Alzamend Neuro - LARVOL DELTA

Alzamend Neuro Reports Second Quarter 2025 Financial Results and Provides Update on Clinical Programs (Businesswire) - "Following successful Phase I and IIA trials, AL001 is positioned for five Phase II trials in partnership with Massachusetts General Hospital in 2025...Alzamend’s secondary candidate, ALZN002, is an active immunotherapy aimed at strengthening the ability of a patient’s immunological system to combat Alzheimer’s. The Phase I/IIA trial assesses its safety and efficacy, with trial resumption planned for 2025 following re-engagement of a new clinical research organization."

New P2 trial • P1/2 data • Alzheimer's Disease • CNS Disorders • Dementia

Study in Subjects With Mild-to-Moderate Alzheimer's Dementia (clinicaltrials.gov) - P1/2 | N=30 | Active, not recruiting | Sponsor: Alzamend Neuro, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • IO biomarker • Alzheimer's Disease • CNS Disorders • Dementia

Study in Subjects With Mild-to-Moderate Alzheimer's Dementia (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Alzamend Neuro, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • IO biomarker • Alzheimer's Disease • CNS Disorders • Dementia

Study in Subjects With Mild-to-Moderate Alzheimer's Dementia (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Alzamend Neuro, Inc.

IO biomarker • New P1/2 trial • Alzheimer's Disease • CNS Disorders • Dementia

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 (Businesswire) - "Alzamend Neuro...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....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."

New P1/2 trial • Trial status • Alzheimer's Disease • CNS Disorders

Ault Alliance Announces Alzamend Neuro Has Initiated Its Phase I/IIA Trial for Its Immunotherapy Vaccine (ALZN002) to Treat Mild to Moderate Dementia of the Alzheimer’s Type (Businesswire) - "Ault Alliance...announce that Alzamend Neuro, Inc. (Nasdaq: ALZN) ('Alzamend') has initiated its Phase I/IIA clinical trial for its immunotherapeutic vaccine (ALZN002) to treat mild to moderate dementia of the Alzheimer’s type. The Company believes this marks a key milestone in clinical drug discovery and development, and Ault Alliance congratulates Alzamend Neuro on this achievement. The primary goal of this clinical trial is to determine the 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."

Trial status • Alzheimer's Disease • CNS Disorders

Alzamend Neuro Reports Third Fiscal Quarter Financial Results and Provides a Business Update (Businesswire) - “Initiation of Phase I/IIA Clinical Trial for ALZN002 to Treat Mild to Moderate Dementia of the Alzheimer’s Type Expected in March 2023. Topline Data from Phase IIA Multiple Ascending Dose Clinical Trial for AL001 in Treatment of Dementia Related to Alzheimer’s Expected in June 2023.”

New P1/2 trial • P2a data • Alzheimer's Disease • CNS Disorders

Alzamend Neuro Partners With Biorasi to Conduct a First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase I/IIA Clinical Trial (Businesswire) - "Alzamend Neuro...announced that it is partnering with Biorasi as its contract research organization ('CRO') to conduct a first-in-human, randomized, double-blind, placebo-controlled, parallel group, phase I/IIA 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....'We are thrilled to add Biorasi to the team and have full confidence in their ability to conduct our Phase I/IIA clinical trial of ALZN002. With the Miller School of Medicine, Interdisciplinary Stem Cell Institute at the University of Miami manufacturing the vaccine as announced on December 28, 2022, Biorasi’s appointment to the team completes all logistics encompassing our ALZN002 clinical trial. We are advancing the process and expect to initiate this study by the end of March 2023.'"

Licensing / partnership • New P1/2 trial • Alzheimer's Disease • CNS Disorders

Alzamend Neuro Partners With the Miller School of Medicine, Interdisciplinary Stem Cell Institute at the University of Miami for ALZN002 Phase I/IIA Immunotherapy Vaccine Clinical Trial to Treat Mild to Moderate Dementia of the Alzheimer’s Type (Businesswire) - "Alzamend Neuro, Inc...announced that it is partnering with the Miller School of Medicine, Interdisciplinary Stem Cell Institute at the University of Miami for its Phase I/IIA clinical trial of 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....'We are advancing the process and expect to initiate this study in the first quarter of 2023'....'We look forward to reporting topline data from the Phase IIA MAD study in the second quarter of 2023...'"

Licensing / partnership • New P1/2 trial • P2a data • Alzheimer's Disease • CNS Disorders

Alzamend Neuro Receives FDA “Study May Proceed” Letter for Phase I/IIA Trial Under Its Investigational New Drug Application for an Immunotherapy Vaccine (ALZN002) to Treat Mild to Moderate Dementia of the Alzheimer’s Type (Businesswire) - “Alzamend Neuro, Inc…today announced receipt of a ‘Study May Proceed’ letter from the U.S. Food and Drug Administration (‘FDA’) for a phase I/IIA clinical trial under its Investigational New Drug (‘IND’) application for an immunotherapy (ALZN002) to treat mild to moderate dementia of the Alzheimer’s type….‘We are advancing the process and expect that the first patient will be dosed in the first quarter of 2023.’”

IND • New P1/2 trial • Alzheimer's Disease • CNS Disorders

BitNile Holdings Announces That Alzamend Neuro Receives FDA “Study May Proceed” Letter for Phase I/IIA Clinical Trial Under Its Investigational New Drug Application for an Immunotherapy Vaccine (ALZN002) to Treat Alzheimer’s Disease (Businesswire) - "BitNile Holdings, Inc...announced that Alzamend Neuro, Inc...received a 'study may proceed' letter from the U.S. Food and Drug Administration ('FDA') for a Phase I/IIA clinical trial under Alzamend’s Investigational New Drug ('IND') application for an immunotherapy vaccine (ALZN002) to treat mild to moderate dementia of the Alzheimer’s type....Alzamend reported that it expects to initiate the clinical trial in the first quarter of 2023. BitNile is a significant beneficial owner of Alzamend common stock."

IND • New P1/2 trial • Alzheimer's Disease • CNS Disorders

Alzamend Neuro Submits IND Application for Phase I/IIA Trial for an Immunotherapy (ALZN002) to Treat Mild to Moderate Dementia of the Alzheimer’s Type (Businesswire) - “Alzamend Neuro, Inc…announced that it submitted an investigational new drug ('IND') application to the U.S. Food and Drug Administration (‘FDA’) for its immunotherapy product candidate ALZN002….The submitted IND supports initial deployment of a clinical trial, ALZN002-01, a first-in-human, randomized, double-blind, placebo-controlled, parallel-group, Phase I/IIA clinical trial. 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.”

IND • Alzheimer's Disease • CNS Disorders • Dementia

"@AlzamendNeuro CEO Stephan Jackman on a potential cure (AL001 & AL002) (lithium 2.0) @alzfdn @TheADDF @alzassociation @alzheimerssoc @DBSAlliance @IntlBipolar" (@Lifeof_JonB)

Alzheimer's Disease • CNS Disorders

Alzamend Neuro Announces Date for Delivery of Topline Data for Phase 1 First-in-Human Clinical Trial for AL001 for Dementia Related to Alzheimer’s (Businesswire) - "Alzamend Neuro, Inc....today announced that it has received confirmation that topline data for its Phase 1 clinical trial for AL001 for dementia related to Alzheimer’s will be delivered mid- to late-December 2021....'We look forward to utilizing these data to move swiftly into a Phase 2 multiple ascending dose study involving Alzheimer’s patients in the first quarter of 2022.'...'We believe it is important to incorporate all of the FDA’s recommendations and guidance, and now anticipate submitting our IND for AL002 in the second quarter of 2022 and commencing a combined Phase 1/2 clinical trial as soon as possible after approval of the IND from the FDA.'"

IND • New P2 trial • P1 data • Alzheimer's Disease • CNS Disorders

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 (Businesswire) - “Alzamend Neuro, Inc…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….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….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.”

IND • New P1/2 trial • Alzheimer's Disease • CNS Disorders