NanoViricides Inc., a development stage company that is creating special purpose nanomaterials for antiviral therapy, announced that on behalf of the company, the European associates of the consulting firm Cote' Orphan Consulting (COC) have submitted an Orphan Drug Application to the European Medicines Agency (EMA) for DengueCide, a drug candidate for the treatment of dengue and dengue hemorrhagic fever.
The company previously engaged the consulting firm Cote' Orphan Consulting, headed by Dr Tim Cote', to assist with the DengueCide orphan drug applications. 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 received Orphan Drug Designation for DengueCide from 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 per cent survival rate.
Interest in a treatment for dengue fever in Europe was confirmed today by the announcement that J&J has signed a collaboration with the Wellcome Trust and the University of Leuven in Belgium.
Recently, thirteen European countries have reported 82 imported dengue cases including a major outbreak on the Portuguese island of Madeira. Dengue fever is considered an “orphan” disease by the EMA.
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.