NanoViricides (OTCBB:NNVC) shares shot up on Monday after it said it anticipates that the oral and injectable versions of its FluCide drug candidate would be effective against the new H7N9 strain of the flu that has caused a slew of deaths in China of late.
Shares of the biopharmaceutical company were lately up almost 7 per cent to 63 cents approaching market close, soaring to as high as 69 cents just after the news was released.
Both the injectable drug, for use in severely ill patients with the flu, and the oral version for less sick out-patients, bear a "virus-binding ligand" that mimics sialic acid, the company told investors this afternoon.
This ligand is capable of substituting for both the mammalian form or the avian form, it added.
Since the novel H7N9 (2013) virus is transitioning from avian to human host, the dual biomimetic capability of our FluCide ligand should have a favorable impact," NanoViricides said in the release.
The FluCide drugs are based on NanoViricides' biomimetic technology, which mimicks the natural sialic acid receptors for the influenza virus on the surface of a nanoviricide polymeric micelle. The company notes that all flu viruses bind to the sialic acid receptors, even if they rapidly mutate.
According to the company statement on Monday, the Center for Disease Control (CDC) and scientists from China and Japan have reported that based on the genetic structure of the new strain, this virus is likely to bind well with the mammalian form of sialic acid.
The virus is also said to be reported to bear other mutations that allow it to infect mammalian hosts effectively.
"Existing H7-vaccine viruses are not well matched to this novel H7N9 virus, and new vaccine development will take some time. This H7N9 is resistant to amantadine and rimantadine, as are most US and European Influenza A virus strains," the company noted.
Though the virus is suggested to be susceptible to Tamiflu and Relenza, certain mutations suggest resistance, NanoViricides noted, citing CDC authors Dr. Uyeki and Dr. Cox, who say that clinical research is "urgently needed on new antiviral agents, including drugs with different
mechanisms of action".
Indeed, FluCide is based on a completely new mechanism of action, where the drug micelle is designed to bind to the virus particle through "multi-denate interactions" and then to spread onto the virus surface, thereby covering the entire virus particle.
Unlike antibodies, the company's nanoviricide agents are designed to perform their antiviral effect even if the immune system is compromised, and can be designed to have as many as 20 or even larger numbers of virus-binding ligands.
Both drugs in its FluCide program have shown “very high effectiveness” in preclinical animal studies of two "distinctly different" influenza A virus infections, NanoViricides noted, routinely showing superiority to Tamiflu, the current standard of care.
Flucide drugs showed complete survival, or 22 plus days, while Tamiflu resulted in only 8 to 9 days of survival, the company said. Untreated animals died within five days.
The results are expected to correlate well with impending human clinical studies, it added. The company has previously reported that it is working on cGMP production of its drug candidates in the near future. The bidding phase for subcontracts for the production and laboratory facilities has already begun.
NanoViricides has a pre-investigational new drug application meeting with the U.S. FDA at the end of March for its injectable FluCide candidate.
Including the FluCide program, it currently has six “commercially important” drug candidates in its pipeline that together address a market size greater than $40 billion. Those include drugs for use against HIV, viral eye diseases, Herpes, and Dengue viruses.
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