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Monday, 22 July 2013
NanoViricides says European clinical coordinators appointed to review upcoming DengueCide orphan drug application
NanoViricides (OTCBB:NNVC) says it has been notified that clinical coordinators in Europe have been appointed to review the company's upcoming orphan drug application for its DengueCide candidate.
The drug is being developed to treat dengue and dengue hemorrhagic fever, a mosquito-borne disease.
The clinical coordinators were appointed by the Committee on Orphan Medicinal Products of the European Medicine Agency, in response to the company's submission of a letter of intent to file the orphan drug application.
NanoViricides said it intends to file this application after the appropriate notice period -- usually 60 days -- has expired. According to its statement released Monday, the actual application will need to be translated into 27 different languages prior to submission, with the company hiring consulting firm Cote Orphan Consulting to assist with the work.
The drug developer has also filed a an orphan drug application for DengueCide, which the company says has shown "very high effectiveness" in animal studies, in the U.S. Indeed, in the mouse study conducted at the University of California, those mice treated with DengueCide achieved a 50 per cent survival rate, as opposed to a 100 per cent fatality rate when left untreated.
NanoViricides said there is currently no drug treatment or vaccine for the dengue virus, with the orphan drug designation expected to help the company give the drug program a higher priority and move it forward rapidly following the development of its flu treatment.
Dengue fever is an old disease that has re-emerged in the past 20 years, with an estimated 400 million cases of the tropical infectious disease in 2013 and between 50,000 to 100,000 deaths annually.
NanoViricides, which has six commercially important drug candidates in its pipeline that together address a market size of greater than $40 billion, is focused first on bringing its FluCide drug candidate to market.
Should the orphan drug designation for DengueCide be granted, the company's plan is to prioritize this program, allowing it to quickly advance the drug following its development of FluCide. It currently has both an oral and injectable version of FluCide, which has the potential to wipe out virtually all strains of the pesky influenza A virus. The company is now preparing for toxicology studies for its first FluCide candidate, expected to be wrapped up before the middle of next year.
Earlier this month, it signed a "confidential disclosure agreement" with Public Health England - the British government's equivalent of the U.S. Center for Disease Control - to develop a specific proposal for the testing of different NanoViricides against viruses of "mutual interest" to both organizations. Specifically, the first two viruses will be H7N9, the flu virus that is now circulating in China, and the latest version of the coronavirus that is spreading in the Middle East and is now referred to as the MERS virus.