Benzinga | Jul 23, 2021 06:34AM EDT

Alzamend Neuro Highlights Receipt Of Toxicology Results For AL002 Ij GLP Toxicology Study Using A Transgenic Mouse Model Of Alzheimer's Disease

AL002 is a Patented Method Using a Mutant-Peptide Sensitized Cell as a Cell-Based Therapeutic Vaccine

Alzamend Neuro, Inc. (NASDAQ:ALZN) ("Alzamend"), a preclinical stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that it has received positive toxicology results for AL002 in a good laboratory practices ("GLP") toxicology study using a transgenic mouse model of Alzheimer's disease. The study was conducted by Charles River Laboratories. 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.

"The positive GLP toxicology results represent a key milestone for Alzamend as we continue to advance our proprietary pipeline. We believe AL002 could potentially reverse the effects of Alzheimer's disease. We look forward to providing more details on the timeline and market opportunity as we prepare for the submission of our Pre-Investigational New Drug Application for AL002 to the U.S. Food and Drug Administration in the near future," commented Stephan Jackman, the Chief Executive Officer of Alzamend.

Overview of the GLP toxicology study

A five-dose GLP study with AL002-sensitized cells was completed using a transgenic (or genetically modified) mouse model of Alzheimer's disease to investigate the tolerability of AL002. Single injections were administered on days 1, 30, 50, 70, and 90. The mice were evaluated for potential toxicity and reversibility of any findings at 75 and 90 days after dosing.

Histopathology results demonstrate that there was no indication of T-cell infiltration or meningoencephalitis suggesting that AL002 therapy is safe and tolerable as there were no adverse findings over a 90-day period and 90 days after the last dose. There were no treatment-related mortalities or reports of adverse effects on clinical observations, body weight parameters, organ weight parameters, clinical pathology parameters, gross pathology observations, or histopathologic observations during the main study or the recovery phase.