NanoViricides, Inc. (OTCBB:NNVC) (the "Company") announced today that it has selected a clinical candidate, now designated NV-INF-1, for FDA submission in its highly successful FluCide™ anti-influenza therapeutics program. The Company is now developing certain additional information on NV-INF-1, with input from its FDA consultants, for the pre-IND application to the FDA. The Company is planning on two separate indications for NV-INF-1: High strength dosage form for hospitalized patients with severe influenza, and a single course therapy for the out-patients with less severe influenza.
In the USA alone, there are approximately 300,000 severe influenza cases that require hospitalization every year resulting in approximately 40,000 deaths. Expert physician advice suggests that the dosage form should be a high strength solution suitable for "piggy-back" incorporation into the standard IV fluid supplement system that is commonly used in hospitalized patients. Since current influenza treatments have limited effectiveness in these patients because of the severity of the infection, there is a significant unmet medical need for the treatment of hospitalized influenza patients, which include immunocompromised patients.
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.
The Company is planning the out-patient treatment as a single injection that a medical office can easily administer when the patient goes for the first clinical visit. The Company believes that in most instances no follow-on treatment would be necessary. This expectation is based on the following results from its animal studies: (1) the extremely high treatment effectiveness in inhibiting the cycle of infection, virus expansion and spread of infection and, (2) the significantly long lasting effects of the drug treatment after the drug is discontinued.
A single course treatment for out-patients is a highly sought after goal in influenza therapeutics. During the 2009 H1N1 "swine flu" pandemic, approximately 61 million cases of out-patient influenza were estimated in the USA alone.
This clinical drug candidate is expected to be effective against a majority of strains and types of influenzas including novel epidemic influenza strains such as the one encountered in 2009-2010 (so called "swine flu"); seasonal flu such as H1N1, H3N2; highly pathogenic types such as H7N and H9N; as well as the highly lethal type, so called "bird flu" or H5N1. All influenza viruses use the same common receptor to bind to human cells. Therefore the Company believes that its influenza drug candidate should work against most of the influenza viruses.
The market size for anti-influenza drugs is currently estimated to be approximately $4-$7 billion worldwide. The Company believes that if its FluCide™ drug becomes available, the influenza drug market size could become substantially larger. The market size for OTC medications for control of influenza symptoms is approximately $2.1 billion dollars annually in the USA, and about £0.6 billion (about $1 billion) in the UK (source: http://www.mintel.com/press-centre/press-releases/410/consumers-cough-up-for-remedies-as-flu-season-starts-early). Similar large market sizes are reported for other countries across the globe.
The Company has previously reported on the extremely high efficacies of its optimized FluCide™ drug candidates. The Company is now advancing one of the tested optimized FluCide candidates as the clinical drug candidate after performing substantial further analysis.
A call for robust H5N1 influenza preparedness and response