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.