NanoViricides chooses clinical anti-flu candidate for FDA submission

Drug maker NanoViricides (OTCBB:NNVC) announced Tuesday that it has selected its first clinical candidate for its anti-flu program to be submitted to the FDA.
The candidate, now termed NV-INF-1, is part of its FluCide drug program designed to combat influenza, using nanomaterials for viral therapy. The company's nanoviricide class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them.
The company said it is now developing additional information on NV-INF-1, with the help of FDA consultants, for the pre-investigational new drug application to the FDA.
Two separate indications for the drug are planned. The first - a high strength dosage for hospitalized patients with severe flu - and the second - a single course therapy for out-patients with a less serious form of the virus. The out-patient treatment would be given as a single injection that could be easily administered in a medical office.
NanoViricides has previously reported that its optimized FluCide drug candidates tested positively in pre-clinical animal studies, with one of these candidates having been chosen for FDA submission after further testing and analysis. Results showed effectiveness in inhibiting the cycle of infection, and the spread of the virus, as well as long-lasting effects after drug use was stopped.
In the US alone, there are approximately 300,000 severe influenza cases that require hospitalization every year, resulting in approximately 40,000 deaths, said the company.
In addition, during the 2009 H1N1 "swine flu" pandemic, approximately 61 million cases of out-patient influenza were estimated in the US alone.
"NV-INF-1 promises to be a highly effective anti-influenza drug, based on the extremely high efficacy observed in animal studies, and the company believes that it would receive rapid and widespread acceptance for the treatment of hospitalized patients with severe influenza," it added in a statement.
Indeed, the NV-INF-1 is expected to be effective against a majority of flu strains, including swine flu, bird flu, and seasonal flu types. According to NanoViricides, the market size for anti-influenza drugs is currently estimated to be approximately $4 to $7 billion worldwide.
Aside from the flu, the company is developing nanoviricide drugs against a number of viral diseases including HIV, oral and genital Herpes, viral diseases of the eye, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.