Since 1970, dengue has grown to be a major health problem according to the World Health Organization Fact Sheet no. 117 (November 2012) and it’s one NanoViricides, Inc. hopes to tackle with its current European Medicines Agency (EMA) drug application. From the July 2, 2013 news item on Azonano,
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 has recently filed an Orphan Drug Designation application for DengueCide to the US FDA.
The July 1, 2013 NanoViricides news release, which originated the news item, goes on to explain (a direct link to the news release is not possible but you can find it on the company’s home page),
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).
The news release also describes the proposed DengueCide treatment’s effectiveness in animal trials,
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 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.
In an attempt to give their DengueCide application more heft, the news release provides a description of the company’s work with anti-influenza drugs,
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.
I hope they are successful with this new dengue drug. Oddly, the news release seemed to understate the scope of the problem. Here’s more from the WHO (World Health Organization) fact sheet no. 117,
The incidence of dengue has grown dramatically around the world in recent decades. Over 2.5 billion people – over 40% of the world’s population – are now at risk from dengue. WHO currently estimates there may be 50–100 million dengue infections worldwide every year.
Before 1970, only nine countries had experienced severe dengue epidemics. The disease is now endemic in more than 100 countries in Africa, the Americas, the Eastern Mediterranean, South-east Asia and the Western Pacific. The American, South-east Asia and the Western Pacific regions are the most seriously affected.
Cases across the Americas, South-east Asia and Western Pacific have exceeded 1.2 million cases in 2008 and over 2.3 million in 2010 (based on official data submitted by Member States). Recently the number of reported cases has continued to increase. In 2010, 1.6 million cases of dengue were reported in the Americas alone, of which 49 000 cases were severe dengue.
Not only is the number of cases increasing as the disease spreads to new areas, but explosive outbreaks are occurring. The threat of a possible outbreak of dengue fever now exists in Europe and local transmission of dengue was reported for the first time in France and Croatia in 2010 and imported cases were detected in three other European countries. A recent (2012) outbreak of dengue on Madeira islands of Portugal has resulted in over 1800 cases and imported cases were detected in five other countries in Europe apart from mainland Portugal.
An estimated 500 000 people with severe dengue require hospitalization each year, a large proportion of whom are children. About 2.5% of those affected die.