NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has submitted a pre-IND Meeting Request to the US FDA. The Company has requested an initial meeting with the US FDA to review the Company's proposed strategy and plan for conducting safety/toxicology studies and human clinical trials required for approval of its anti-influenza clinical drug candidate, FluCide™ (i.e. NV-INF-1).
“This submission is a major milestone in the Company's program to obtain US FDA approval for FluCide™”
"This submission is a major milestone in the Company's program to obtain US FDA approval for FluCide™," said Eugene Seymour, MD, MPH, CEO, adding, "FluCide has demonstrated excellent efficacy and safety when treating influenza infections in our animal studies. We anticipate similar strong results in humans when the drug becomes available for human use."
The Company has submitted required introductory documentation with the meeting request letter in consultation with the Company's regulatory matters consultants, viz. the Biologics Consulting Group. The Company plans to submit additional briefing documents at least thirty days before the FDA meeting, in compliance with the FDA guidelines.
This pre-IND meeting request submission follows the Company's recent announcement that it has chosen a clinical candidate, NV-INF-1, in its anti-influenza drug program (FluCide™) to develop for regulatory submissions both domestically and internationally. It is estimated that there are about 50 million cases of influenza annually in the USA alone, and about 250,000 patients are hospitalized for influenza. The Company believes that a single course of therapy that can be easily administered by a medical office is likely to be feasible for out-patients, with no additional follow-on treatment 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. In addition to out-patients, the Company also plans to develop an indication for hospitalized severe cases of influenza.
The Company has recently announced that it is working on developing cGMP ("current Good Manufacturing Practices") manufacturing capability for the production of its drug candidates. cGMP manufactured materials will be required when the Company is ready to file an Investigational New Drug (IND) application to the US FDA.
Researchers develop new way to make vegan food more appetizing