Norovirus is the most common cause of acute gastroenteritis in the United States, associated annually with 19-21 million illnesses, 56,000-71,000 hospitalizations and 570-800 deaths (US CDC, Overview about Norovirus). Norovirus is one of the nonenveloped viruses that are resistant to alcohol sanitization. According to US CDC Guidelines for the Prevention and Control of Norovirus Gastroenteritis Outbreaks in Healthcare Settings, the primary method for prevention of norovirus transmission by hand is hand wash with soap and water. However, this method does not inactivate norovirus, but rather releases and washes the virus off the skin. Currently available agents that are able to inactivate norovirus are toxic to human cells. In fact, viral outbreaks worldwide are on the rise despite the increased effort to prevent them. Our goal is to develop several effective, non-toxic, environment-friendly hand sanitizer/surface disinfectants to aid in the prevention of viral outbreaks, particularly norovirus prevention. During Phase I of the STTR project, we focused on testing the proof-of-concept that novel sanitizer formulations (ProtecTeaV) containing EGCG-palmitate are capable of inactivating norovirus and bacteria. We have successfully identified ProtecTeaV formulations with virucidal activity and this activity persists on a clean surface beyond a 12-hour period. The new findings have been published in the International Journal of Microbiology & Infectious Diseases (Widjaja et al, 2018). The objectives of our Phase II proposal include optimization and finalization of the ProtecTeaV formulation in several prototypes; testing these prototypes and receiving approval from regulatory agencies; and conversion of the prototypes to large scale production-ready products. The R&D effort will continue to be based on the existing strong partnership between Camellix and Augusta University, our current manufacturer partner, and experts in formulation, regulatory, production, and business development. We expect to launch the first ProtecTeaV product at the completion of this project.
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, we have identified an effective, non-toxic, environment-friendly, and long-lasting sanitizer formulation against norovirus. In the Phase II proposal, we will optimize and finalize the formulation to produce several prototypes for regulatory approval and prepare to scale-up for mass production.