NanoViricides (OTCBB:NNVC) says that its orphan drug application in Europe for its DengueCide candidate has been submitted, putting the company one step closer to developing a drug to treat the mosquito-borne dengue virus.
The application was submitted to the European Medicines Agency on behalf of the company by the European associates of consulting firm Cote Orphan Consulting. The drug candidate already has orphan status in the U.S., which the company announced last month.
DengueCide, which is in pre-clinical development stage, still has to go through the human trial stage.NanoViricides, which has six commercially important drug candidates in its pipeline that together address a market size of greater than $40 billion, says DengueCide 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. There is currently no drug treatment or vaccine for the dengue virus, with the orphan drug status expected to help the company give DengueCide a higher priority and move it forward rapidly following the development of its own flu treatment, FluCide.
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.
The company said in its statement Tuesday that interest in the disease in Europe was confirmed by the announcement last week that Johnson & Johnson has signed a collaboration with the Wellcome Trust and the University of Leuven in Belgium to develop antiviral drugs for the dengue infection.
According to the NanoViricides release, 13 European countries have reported 82 imported dengue cases, including a major outbreak on the Portuguese island of Madeira.
Aside from DengueCide, the drug development company is first focused on bringing its FluCide treatment to market. 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.
So far in 2013, NanoViricides' stock has surged over 160 per cent, closing Friday at $1.21.