Alzamend Neuro: Positive Pre-IND FDA Response for Alzheimer's Candidate

 FDA Agrees to Alzamend’s Plan to Conduct a Combined Phase 1 and 2 Clinical Trial for AL002

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 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. 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.

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.

https://finance.yahoo.com/news/alzamend-neuro-receives-positive-pre-141100659.html