NanoViricides (OTCBB:NNVC) provided Tuesday an update to its flu program, and said that both its oral anti-flu and related injectable drug have now shown "significantly superior" results to Tamiflu against an H1N1 strain of the flu that is the same type as the 2009 epidemic virus.
The previously reported animal study results were reiterated as the company also announced that a "highly optimized" floor plan for its cGMP production facility for its nanoviricide drugs has now been completed by its design team.
The company’s cGMP (current good manufacturing practice) facility is being designed to produce sufficient quantities of the drugs needed for human clinical trials that will test various nanoviricide drug candidates as they advance into the FDA process further.
The development-stage company is developing its NanoViricides class of drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal influenza, HIV, oral and genital herpes, viral diseases of the eye, Dengue fever, and Ebola virus, among others.
It is first focused on advancing its FluCide drug candidates through the regulatory process, and has already designed the toxicology and safety pharmacology studies for the IND submission and the first-in-human clinical trials of its FluCide investigational anti-flu product.
"The need for an effective, broad-spectrum, anti-influenza drug cannot be overstated," said CEO Eugene Seymour. "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."
NanoViricides' injectable anti-flu drug, NV-INF-1, is intended for use in hospitalized patients with the flu, and the company has said it could receive an orphan drug classification for use in immuno-compromised patients.
It has also developed an oral anti flu drug candidate, NV-INF-2, which it has said may be the "first ever nanomedicine drug of any kind that is active when administered orally." The drug is being developed for out-patient flu cases, and may also be useful for influenza prophylaxis, as in use for the protection of health care workers.
"We have clearly demonstrated that the design platform technology for NanoViricides allows development of powerful broad-spectrum antiviral drugs," added president Anil R. Diwan.
"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.
"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."
Last year, the company reported that its anti-flu drugs have reduced viral loads from "tens to hundreds of times" lower levels than Tamiflu. Both the oral and injectable forms of the drug protected the lungs of the animals, which was reflected in the "strong increase in survival time in the FluCide-treated animals as compared to Tamiflu", the drug maker said.
"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," concluded Diwan.
Shares in the company advanced more than 2.3% to 49.8 cents late this morning.