NanoViricides, Inc. (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.
About Dengue and Dengue Hemorrhagic Fever
Dengue fever, a very old disease, has reemerged in the past 20 years with an expanded geographic distribution of both the viruses and the mosquito vectors, increased epidemic activity, the development of hyper-endemicity (the co-circulation of multiple serotypes), and the emergence of dengue hemorrhagic fever in new geographic regions. In 2013, this mosquito-borne disease is one of the most important tropical infectious diseases globally, with an estimated 400 million cases of dengue fever, over one million cases of dengue hemorrhagic fever, and 50,000-100,000 deaths annually. Dengue virus occurs in four primary serotypes. Although the disease is endemic in many tropical parts of the world, it is considered an orphan disease in the USA and Europe. (From Clinical Microbiology Reviews).
NanoViricides is developing broad-spectrum anti-influenza drugs as part of its rich drug pipeline. The Company believes that its FluCide™ drug candidates will be effective against most if not all influenza viruses, including the H7N9 bird flu, H3N2 or H1N1 epidemic viruses, H5N1 bird flu, seasonal influenzas, as well as novel influenza viruses. This is because FluCide is based on the Company’s biomimetic technology, mimicking the natural sialic acid receptors for the influenza virus on the surface of a nanoviricide® polymeric micelle. It is important to note that all influenza viruses bind to the sialic acid receptors, even if they rapidly mutate. The FluCide drug candidates have already shown strong effectiveness against H1N1 and H3N2 influenza viruses in highly lethal animal models. The injectable FluCide drug candidates have shown 1,000X greater viral load reduction as compared to oseltamivir (Tamiflu®), the current standard of care, in a highly lethal influenza infection animal model. The Company believes that these animal model results should translate readily into humans.
NanoViricides has also developed an oral drug candidate against influenza. This oral version is also dramatically more effective than TamiFlu in the animals given a lethal influenza virus infection. This oral FluCide may be the very first nanomedicine that is effective when taken by mouth.
In addition, NanoViricides has developed drug candidates against Dengue, HIV/AIDS, Herpes, and Ocular Viral Diseases that have shown strong effectiveness in relevant animal and/or cell culture models.