Despite mandatory use of hand sanitizer on cruise ships, there are 15 reported cruise ship onboard norovirus outbreaks in 2015, exceeded the number of norovirus outbreaks (9 outbreaks) onboard cruise ships in 2014. One of the problems of currently available alcohol-based hand sanitizer is that alcohol evaporates in less than 20 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-1/2, 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-3-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, 2015). 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, 2015).
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 20 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.
