BEVERLY, MA--(Marketwired - July 07, 2016) - NanoAntibiotics, Inc. (OTC PINK: NNAB) (the "Company," soon to be known as BioVie Inc.), a development stage company focused on the discovery, development, and commercialization of innovative drug therapies, announced today the filing of US, Japanese and international (PCT) patent applications. The applications aim to achieve patent protection for the Company's novel CIPT Technology being developed for the treatment of ascites due to liver cirrhosis. The PCT filing is an important step towards safeguarding the technology in Europe and potentially other countries.
The FDA has never approved any drugs specifically for the treatment of ascites, and CIPT Technology offers the potential for a new therapeutic option for patients with this life-threatening condition. "This is an important component of our plan to develop a unique and proprietary new therapy for ascites, and ultimately improve patient care at home and abroad," commented Jonathan Adams, CEO of the Company.
The Company collaborated with its Italian advisor, Professor Paolo Angeli of the University of Padova, to generate data supporting the patent claims. Dr. Angeli is Head of the Unit of Hepatic Emergencies and Liver Transplantation at the University, and is a frequent speaker and widely published expert on liver disease. Penny Markham PhD, the Company's Chief Scientific Officer, also made important contributions to the applications.
NanoAntibiotics (BioVie) recently launched a new website, www.nanoantibiotics.com. The Company's goal is to commence a clinical trial program as early as 2017 upon FDA acceptance of an Investigational New Drug ("IND") application, currently in development.
About Liver Cirrhosis and Ascites
About 1 million Americans and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th leading cause of death due to disease in the US, killing an estimated 27,000 people each year. The condition results primarily from hepatitis, alcoholism, and fatty liver disease linked to obesity. Ascites is a common complication of advanced liver cirrhosis, involving kidney dysfunction and the accumulation of large amounts of fluid in the abdominal cavity. With no medications approved by the FDA specifically for treating ascites, an estimated 40% of patients die within two years of diagnosis. Certain drugs approved for other uses may provide initial relief, but patients may fail to respond to treatment as ascites worsens. This represents a critical unmet medical need. US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.
About NanoAntibiotics (BioVie)
NanoAntibiotics, Inc. (soon to be known as BioVie Inc.) is a development stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on commercializing CIPT Technology, a novel approach to the treatment of ascites due to liver cirrhosis. In early 2016 the Company held a pre-investigational new drug ("pre-IND") meeting with the FDA, which provided guidance for an IND submission. The Company's new drug candidate could potentially commence US clinical trials as early as 2017.
The Company's patent applications are subject to regulatory risks and may never be approved. This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause NanoAntibiotics' actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. NanoAntibiotics has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are NanoAntibiotics' need for, and the availability of, substantial capital in the future to fund its operations and research and development. The fact that NanoAntibiotics' compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in NanoAntibiotics' filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. NanoAntibiotics undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.