NanoViricides (OTCBB:NNVC) has submitted a letter of intent to file an orphan drug application with European regulatory authorities for DengueCide, the company's drug candidate for treating the mosquito-borne dengue virus.
The European Medicines Agency, unlike the U.S. counterpart, requires at least 60 days notice of intent to file prior to the actual application.
The drug developer has already filed an application for orphan drug designation in the U.S., having hired Cote Orphan Consulting to assist with the process.
DengueCide is a nanoviricide drug that has proven, according to the company's statement released Monday, to be highly effective in animal studies. Indeed, during the pre-clinical study conducted at the University of California, mice left untreated when infected with the virus were 100 per cent fatal, while the mice that were treated with DengueCide showed a 50 per cent survival rate.
NanoViricides said that there is neither an effective drug nor vaccine candidate 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 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.
Shares of NanoViricides have rallied almost 53 per cent so far this year, closing Monday at 71 cents.
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