WEST HAVEN, CONNECTICUT -- January 31st, 2012 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has submitted a pre-IND briefing document to the US FDA. This submission provides the required information for the Company’s highly effective anti-influenza drug candidate, FluCide™, in support of a pre-IND Meeting. The Company anticipates that the pre-IND Meeting would take place in March-April 2012. The actual meeting date will be assigned by the FDA.
FluCide has been shown to be highly effective in controlling viral influenza in a lethal influenza infection mouse model. In addition, in a direct “head to head” comparison with TamiFlu, the current treatment standard, all of the NV-INF-1 treated animals survived the lethal infection through the duration of the study while none of the TamiFlu-treated animals survived beyond 8 days.
The Company intends to use the pre-IND Meeting opportunity to obtain concurrence from the FDA on its planned toxicological studies, as well as the general plan for the early human clinical trials. In addition, the Company plans to discuss its Chemical Manufacturing and Controls (CMC) program for the cGMP manufacture of FluCide™. cGMP production of FluCide™ is required for the human clinical studies. The Company also plans to discuss additional pre-clinical studies that may be necessary for completing an Investigational New Drug (IND) application.
Over the last several months, the Company has been working closely with its consultants at the Biologics Consulting Group, Inc., to develop this pre-IND briefing submission. Both our consultants and our scientists believe that this pre-IND briefing document fulfills all of the requirements for submission.
NV-INF-1, the selected candidate drug substance of the FluCide program, has been shown to be highly effective in controlling influenza viral infection in lethal infection mouse model. Depending upon the treatment protocol, NV-INF-1 has shown viral load reduction of 1.3 logs to 3 logs in these various studies, as previously reported. In contrast, oseltamivir (Tamiflu®) treatment in the same studies has resulted in viral load reductions of only about 0.2 logs to 0.8 logs. In addition, the animals survived for full duration of the study (21 days) when treated with NV-INF-1 on alternate days. In contrast, oseltamivir-treated animals (40mg/kg given every day) survived for only 8 days. Untreated animals survive only 5 days in this highly lethal influenza infection model. Further, the lung damage caused by the influenza virus infection is also substantially reduced upon FluCide treatment as compared to oseltamivir treatment. Our data indicate that NV-INF-1 is significantly more effective compared to the standard-of-care drug for influenza, viz. oseltamivir.
The Company believes that this anti-influenza drug candidate, NV-INF-1, is expected to be effective against most if not all strains of Influenza A. The Company has previously performed in vitro cell culture studies against two different strains of H5N1 bird flu in Vietnam at the National Institute of Hygiene and Epidemiology (NIHE). The un-optimized drug candidates then employed had shown significant efficacy against both strains of H5N1 in the cell culture model of virus infection. The Company has since conducted a drug candidate optimization program, guided by molecular bioinformatics and rational drug design, which has resulted in substantial improvements in efficacy, as previously reported.
The Company plans to develop this drug for two different indications: (1) for uncomplicated out-patient influenza cases, and (2) for severely ill, hospitalized patients diagnosed with influenza-like-illness (ILI). The Company believes that a single treatment may be sufficient for uncomplicated non-severe influenza patients. This single treatment can be readily administered in a medical doctor’s office at the patient’s first visit. A more aggressive, daily treatment piggy-backed on the usual saline infusion, is anticipated to be effective for severely ill hospitalized patients that are later confirmed to have influenza viral infection. Since several respiratory viruses employ the same receptor to invade cells, it is likely that FluCide may have efficacy against those respiratory viruses in the severely ill hospitalized ILI patients thus expanding the medical benefit of FluCide.
In other news, the Company reports that the design phase of its cGMP production facility is proceeding satisfactorily. The Company has previously reported that Inno-Haven, LLC, has acquired an 18,000 sq.ft. facility in Shelton, CT, that is to be converted into a pilot cGMP production facility for nanoviricides drug products.