NanoViricides submits FDA new drug meeting request for FluCide

NanoViricides, Inc. (OTC:NNVC)  has submitted a pre-investigational new drug meeting request to U.S. health regulators to review its drug candidate FluCide, the company announced Monday.

The company said it has asked for an initial meeting with the Food and Drug Administration to review the company’s plan for conducting safety and toxicology studies and human clinical trials needed for approval. 

NanoViricides chief executive Eugene Seymour said: "This submission is a major milestone in the company’s program to obtain FDA approval for FluCide."

The anti-virus vaccine-focused company, which submitted the required introductory documentation, said it plans to submit extra briefing documents about 30 days prior to the FDA meeting. 

NanoViricides’ meeting request follows the company’s recent announcement it has chosen a clinical candidate, FluCide, to develop for regulatory submissions both domestically and abroad.   

It is estimated that there are about 50 million cases of influenza a year in the U.S. alone, and about 250,000 patients are hospitalized for influenza. 

NanoViricides said that FluCide has shown excellent efficacy and safety when treating for influenza infections during animal studies and expects to see similar strong results in humans when the drug becomes available for human use. 

Recently, NanoViricides said it is working on developing current Good Manufacturing Practices manufacturing capability for production of its drug candidates, which will be required when the company is ready to file an investigational new drug application to the FDA. 

Currently, NanoViricides has five drug development programs within its pipeline, including FluCide, a vaccination program against all forms of influenza, including bird flu, high path flus, seasonal flus, and epidemic flus, and HIVCide, a drug that works against the HIV/AIDS virus, which the company says could become a "functional cure" for the disease. 

NanoViricides makes anti-viral therapies using nanomaterials. The company also develops its therapies against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and  genital Herpes, and Hepatitis C, among others. 

Shares of NanoViricides rose six cents, or 8.96 percent, to trade at 73 cents today on the OTC, or over the counter markets.