Alzamend Neuro, Inc. (NASDAQ: ALZN) disclosed on Friday that the firm has presented a pre-IND request for AL002 and supporting briefing documents to the Center for Biological Evaluation and Research of the U.S. FDA. It has been confirmed by the firm that preclinical work back AL002 being linked with a positive anti-inflammatory response and a decrease in brain amyloid contents.
AL002 is a patented method using a mutant-peptide induced cell as a cell-based therapeutic vaccine that pursues to reinstate the power of an immunological system of sufferers to fight Alzheimer’s. Shares of Alzamend plunged -1.93% during the pre-market trading session of Friday.
Furthermore, the firm has disclosed that the Phase 1 clinical study will be a controlled clinical trial carried out at Emory University School of Medicine, with Ihab Hajjar, MD, as the principal investigator, with the participation of the Emory Personalized Immunotherapy Center.
It has been disclosed that this preliminary study will be a placebo-controlled, double-blinded, clinical trial in sufferers with early-stage, mild to moderate, Alzheimer’s. It is intended to assess feasibility depends on efficacy measures, toxicity, safety, and tolerability of AL002 cure.
Moreover, volunteers will be registered and medicated for six months, and then followed for another six months for safety, for a total registration of one year. A temporary statistical analysis is prearranged after six months which pursues the multiple-dosing phase of the study.