NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that March 29th, 2012 has been confirmed by the US FDA as the date for its initial meeting with the Company's scientists. This pre-IND meeting will focus on FluCide™, designated as NV-INF-1, the Company's novel anti-influenza drug.
The Company continues to work with the Biologics Consulting Group, Inc., Alexandria, VA (BCG), to prepare for this meeting. We have conducted face-to-face discussions with BCG regarding the pre-IND meeting, in addition to the customary ongoing teleconferences.
The Company's initial indications for the drug are anticipated to be (a) a "piggy-back" solution for delivery via the customary IV infusion for hospitalized patients presenting with Influenza-Like-Illness (ILI), and (b) out-patient influenza. The Company continues to develop injectable formulations for both of these indications, as its first generation anti-influenza drugs.
The Company has also planned a strategy for a future second generation oral anti-influenza drug for out-patient influenza cases, based on our discussions with BCG. While the Company believes that it is feasible to design and formulate our nanoviricide® drugs for oral uptake, the Company has not yet begun the necessary development work. The Company therefore continues to work on development of our injectable drug against influenza towards US and International approvals.
In the USA alone, there are approximately 300,000 severe influenza cases that require hospitalization every year, with 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.
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.
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