Novel sanitizer against viral infections with long lasting effect

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI124738-01A1
Agency Tracking Number: R41AI124738
Amount: $192,601.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA15-270
Timeline
Solicitation Year: 2015
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-02-01
Award End Date (Contract End Date): 2017-11-30
Small Business Information
1120 15TH ST CA 2151, Augusta, GA, 30912-0004
DUNS: 968429386
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: N
Principal Investigator
 STEPHEN HSU
 (706) 721-4816
 shsu@augusta.edu
Business Contact
 STEPHEN HSU
Phone: (706) 721-4816
Email: shsu@gru.edu
Research Institution
 AUGUSTA UNIVERSITY
 1120 15TH STREET
AUGUSTA, GA, 30912-0004
 Nonprofit college or university
Abstract
Project Summary Abstract Despite mandatory use of hand sanitizer on cruise ships there are reported cruise ship onboard norovirus outbreaks in exceeded the number of norovirus outbreaks outbreaks onboard cruise ships in One of the problems of currently available alcohol based hand sanitizer is that alcohol evaporates in less than seconds after each application to a surface leaving a surface or skin as a platform readily to transmit virus Unfortunately alcohol is not effective against nonenveloped viruses such as norovirus adenovirus hepatitis A virus human papilloma virus and polio virus Novel strategies for prevention of viral infection and outbreaks are in urgent need which should have efficacy and a persistent residue effect on skin or surface after each application EGCG especially lipophilic EGCG have been reported to be an antiviral compound against many types of viruses including HIV herpes Ebola norovirus hepatitis virus B and C influenza virus and many other pathogenic viruses without known toxicity to human or environment at physiological levels This revised STTR Phase I proposal is designed to test the proof of concept that EGCG palmitate in hand sanitizer formulation are effective against noroviruses a nonenveloped virus with persistent effect The unique ingredients in the novel sanitizer products are EGCG palmitate a fatty acyl esters of EGCG epigallocatechin gallate EGCG is a natural compound extracted from green tea leaves Previously published research data including ours indicate that EGCG is a potent inhibitor of various viruses and lipophilic EGCG such as EGCG palmitate and EGCG stearate is more effective than hydrophilic EGCG Due to its lipid soluble stable and non toxic properties lipophilic EGCG is suitable to be used in the next generation of sanitizer products either with or without alcohol to prevent viral infections and outbreaks among humans and animals Camellix LLC is marketing two OTC products containing lipophilic EGCG for treating cold sores herpes labialis which demonstrated high efficacy in a randomized clinical trial Zhao et al Recently Camellix launched an alcohol based ProtecTeaV EGCG hand sanitizer In this proposal investigators from Camellix and Augusta University will determine the efficacy and persistency of novel formulations containing EGCG palmitate on human norovirus surrogates The effective formulations against human norovirus surrogates will be tested for antibacterial activity in comparison to currently recommended hand hygiene methods The proposed Phase I work will lead to two novel formulations containing EGCG palmitate that possess virucidal capability We will apply for Phase II STTR funding to support pre commercialization effort Prototypes of novel products using the two novel formulations will be designed and tested according to FDA requirements for Topical Antimicrobial Drug Products for Over the Counter Human Use Project Narrative Currently used alcohol based hand sanitizers are ineffective against nonenveloped viruses such as norovirus the most common cause of Gastroenteritis and the effectiveness of alcohol only lasts for less than seconds Based on patented technology the SBC Camellix developed a novel hand sanitizer containing lipophilic EGCG which possesses potent antiviral activity This revised STTR Phase I proposal is aimed to test the proof of concept that EGCG palmitate in sanitizer formulations are highly effective against nonenveloped viruses with residue activity

* Information listed above is at the time of submission. *

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