TAMPA, Fla.– 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 submitted a pre-IND meeting request for AL002 and supporting briefing documents to the Center for Biological Evaluation and Research of the U.S. Food and Drug Administration. 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.
“Preclinical work supports AL002 being associated with a positive anti-inflammatory response and a decrease in brain amyloid contents. Based on AL002’s recent positive good laboratory practices toxicology results, we are proposing to conduct a first-in-human Phase 1 study. We believe AL002 could potentially reverse the effects of Alzheimer’s,” said Stephan Jackman, the Chief Executive Officer of Alzamend.
Overview of the proposed clinical study
The Phase 1 clinical study will be a controlled clinical trial conducted at Emory University School of Medicine, with Ihab Hajjar, MD, as the principal investigator, with the involvement of the Emory Personalized Immunotherapy Center. This initial study will be a placebo-controlled, double-blinded, clinical trial in patients with early stage, mild to moderate, Alzheimer’s, designed to evaluate feasibility based on efficacy measures, toxicity, safety, and tolerability of AL002 treatment. Participants will be enrolled and dosed for six months, and then followed for another six months for safety, for a total enrollment of one year. An interim statistical analysis is planned after six months which follows the multiple-dosing phase of the study.
