NanoViricides, Inc. (the "Company") provides an update on its influenza program. The Company states that in a highly lethal animal model against an H3N2 Influenza virus strain, very similar to the current dominant influenza strain, the Company’s oral anti-influenza drug candidate has shown significantly superior efficacy to Tamiflu® (oseltamivir).
This oral anti-influenza drug candidate and its related injectable drug variant have both shown significantly superior efficacy to Tamiflu against influenza A H1N1 strain in the same animal model. The H1N1 strain we used is of the same type as the 2009 epidemic influenza virus, although not the same strain. The Company has previously reported on these studies.
The Company also announced that a highly optimized floor plan for the cGMP production facility for its nanoviricide® drugs is now completed by the design team. The design team has been working together for some time before agreements with the various team members were formalized by the Company. The Company has been working on enabling cGMP facilities for its drug candidates in order to proceed further into the FDA regulatory process.
“The need for an effective, broad-spectrum, anti-influenza drug cannot be overstated,” said Eugene Seymour, MD, MPH, CEO of the Company, adding, “The current 2012 influenza season is already considered to be an epidemic. The current vaccine did not work well even though the same strain of H3N2 that is causing serious cases, was included in the vaccine mix. Vaccine effectiveness is only around 60%. In the previous 2009 epidemic, the virus swept the world long before a vaccine could become available. The 2009 virus was a novel strain, even though it was a subtype of H1N1. Vaccines are highly specific (narrow-spectrum) because they elicit antibodies in the human host, and antibodies are by nature very specific to their target.”
“We have clearly demonstrated that the design platform technology for nanoviricides allows development of powerful broad-spectrum antiviral drugs,” said Anil R. Diwan, PhD, President and Chairman of the Company, “We have developed a small chemical ligand that mimics both the mammalian (or a-2,6-) and avian (or a-2,3) forms of the native sialic acid receptor of influenza viruses. We can design a nanoviricide to exhibit several ligands at a single point, and each nanomicelle may exhibit several hundred ligands on its small surface. The ligands are designed to look very much like (mimic) the sialic acid to the influenza viruses, and the high density of the ligands would force the virus to land onto the nanoviricide and get destroyed by the hidden ‘tails’ of the nanomicelle that snap out and merge into the viral surface lipid coat.”
Binding to sialic acid on the cell surface is a completely conserved property of all influenza viruses. The avian influenza viruses tend to prefer binding to the a-2,3- variant of sialic acid, whereas those causing disease in humans tend to prefer binding to the a-2,6 variant. Pigs and some other species serve as “mixing species” where both the avian and mammalian viruses can grow, and further, avian viruses can mutate to mammalian viruses.
The Company has previously reported that its anti-influenza drug candidates have reduced viral loads from tens to hundreds of times lower levels than oseltamivir (Tamiflu®), depending upon the particulars of the experiment. The FluCide™ oral and injectable drug candidates also protected the lungs of the animals much better than did oseltamivir, indicating a clear benefit. The protection from influenza virus was clearly reflected in the strong increase in survival time in the FluCide-treated animals as compared to oseltamivir. Mice serve only as a “test tube” in these studies, since our drugs are designed to attack the virus particles directly. Thus these positive results in animal studies are expected to correlate well with the human clinical trials.
“We are rapidly advancing towards our goal of filing an IND with the FDA for Influenza based on the guidance we received in our previous pre-IND meeting with the FDA,” said Anil R. Diwan, President of the Company.