NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has submitted its letter of intent to file an Orphan Drug Application with the European Medicines Agency (EMA) for DengueCide™, its drug candidate for the treatment of dengue and dengue hemorrhagic fever. EMA requires a notification of intent to file at least 60 days prior to the actual filing, unlike the US FDA. The actual application will need to be translated into 27 different languages prior to submission.
The Company previously engaged the consulting firm Cote´ Orphan Consulting (COC), headed by Dr. Tim Cote´, to assist with the orphan drug application. The Company, in consultation with COC, has determined that its current lead DengueCide drug candidate is eligible for orphan drug status application in the European Union. The Company has recently filed an Orphan Drug Designation application for DengueCide to the US FDA.
DengueCide is a nanoviricide® that has shown very high effectiveness in an animal model of dengue virus infection. These animal studies were conducted in the laboratory of Dr. Eva Harris, Professor of Public Health and Infectious Diseases at the University of California, Berkeley. Professor Harris has developed a mouse model simulating antibody-dependent-enhancement (ADE) of dengue infection using a special laboratory mouse strain called AG129. ADE in humans is thought to lead to dengue hemorrhagic fever and is associated with a high fatality rate. In this model, infection with a dengue virus when the mice are left untreated is 100% fatal. In contrast, in the same study, animals treated with NanoViricides' DengueCide achieved an unprecedented 50% survival rate.
There is currently neither an effective drug treatment nor a vaccine for dengue virus infection. Tremendous efforts have been made for dengue vaccine development but, to date, no vaccine candidate has succeeded in clinical trials towards approval.
An orphan designation for our dengue drug candidate, if granted, is expected to help the Company assign a higher priority to its dengue drug program and undertake rapid development following the influenza drug candidates.