SEC Filings

8-K
DPW HOLDINGS, INC. filed this Form 8-K on 02/25/2019
Entire Document
 
 

Our Science Alzamend ™ Therapeutic Drug Synopsis Strength Status LiProSal™ ▪ Use of patented Ionic Cocrystal (ICC) technology delivering a therapeutic combination of Lithium, Proline, and Salicylate ▪ Lithium as a treatment of agitation and other possible symptoms in patients with indication of Alzheimer’s disease ▪ Other potential indications: Dementia, Parkinson’s Disease, ALS, Depression, Bi - Polar Disorder, Mania, Post Traumatic Stress Disorder (PTSD), Suicidality, etc. ▪ Exclusive license for Cocrystal delivery system for AD and psychiatric indications ▪ Eligible for “breakthrough therapy” designation from FDA ▪ Repurpose of Lithium, recognized as mood stabilizer by FDA, with the potential to receive approval of 505(b)(2) clinical trial pathway from FDA ▪ FDA has established a separate fast - track clinical process for Cocrystal based technologies ▪ Accelerated path for the treatment of Alzheimer’s, deemed “unmet need” by the FDA ▪ Filing pre - IND and IND in Q2 2019 ▪ Commencing human clinical trials in Q3 2019 CAO22W ▪ A patented method using a mutant peptide sensitized cell as a cell - based therapeutic vaccine that reduces beta - amyloid plaque and seeks to restore the ability of the patient’s immunological system to combat Alzheimer’s disease. ▪ Also seeks to mitigate adverse reactions from a patient’s immunological system experienced during pre - clinical trials including the highly publicized Elan study (AN - 1972) ▪ This is the only therapeutic vaccine designed for the treatment and prophylactics of Alzheimer’s ▪ Difficult to manufacture and hence not easily replicated by competitors ▪ Eligible for “breakthrough therapy” status via FDA ▪ Significant support that beta - amyloid plaque is a cause in the development/progression of AD from recent Phase II Clinical Trial results released by Biogen/ Esai ▪ Accelerated path for the treatment of Alzheimer’s, deemed “unmet need” by the FDA. ▪ Completing pre - clinical studies and filing pre - IND in Q2 2019 ▪ Filing IND in Q3 2019 ▪ Commencing human clinical trials in Q4 2019 Alzamend Neuro, Inc. Information cannot be disclosed or reprinted without prior written permission from Alzamend Neuro, Inc . February 2019 116