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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
Topline Data for Phase IIA Multiple Ascending Dose Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s Expected in Second Quarter of 2023
About this update from Alzamend Neuro, Inc.
[{"type":"text","content":"\n\nTopline Data for Phase IIA Multiple Ascending Dose Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s Expected in Second Quarter of 2023\n\n\n ATLANTA--(BUSINESS WIRE)--\nAlzamend 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 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.\n\n“We are thrilled to add the Miller School of Medicine, Interdisciplinary Stem Cell Institute at the University of Miami to the team and have full confidence in their ability to assist us with our Phase I/IIA clinical trial of ALZN002,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We strongly believe that the ALZN002 patient-specific immunotherapeutic vaccine has the potential of fostering 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. We are advancing the process and expect to initiate this study in the first quarter of 2023.”\n\nOn October 5, 2022, Alzamend announced the addition of healthy adult subject to its Phase IIA multiple ascending dose (“MAD”) study of AL001 in subjects with dementia related to Alzheimer’s. This blinded, placebo-controlled trial (AL001-02) was initiated in May 2022 and is designed to evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions and determine the maximum tolerated dose. This addition to the MAD study was based upon a recommendation by the U.S. Food and Drug Administration after its review and commentary on Alzamend’s pre-investigational new drug briefing package for development of AL001 for bipolar disorder, MDD and PTSD. As the safety and tolerability of AL001 would need to be tested in healthy and elderly adults before Alzamend could initiate later-stage testing o...