Tuesday, 4 June 2013

NanoViricides’ FluCide: a potential cure for the flu, drug to enter human trials next year

Development-stage NanoViricides (OTCBB:NNVC) has everything it needs to drive shareholder value, with a potential money-maker in its hands in the form of a cure for the common flu. The company is now preparing for toxicology studies for its first FluCide candidate, expected to be wrapped up before the middle of next year. 
The drug candidate has the potential to wipe out virtually all strains of the pesky influenza A virus, including the recent H7N9 avian strain that has been plaguing China. 
FluCide, which is based on a completely new mechanism of action, is based on the company's nanoviricide technology, the combination of a nanomicelle - a biodegradable, non-toxic polymeric-based structure - that is then attached to a "ligand". 
These ligands are designed to mimic the sialic acid receptors, which exist on the surface of the target cell of the virus, to the flu virus. The nanoviricide is then charged with its task of first binding to the virus particle and then spreading onto and over the viral surface, finally encapsulating the entire virus particle. 
Once this happens, the virus is incapable of inserting its genetic material into its target cell, meaning it cannot replicate. 
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. 
NanoViricides, which based on this technology has six commercially important drug candidates in its pipeline that together address a market size of greater than $40 billion, has two FluCide candidates in hand – an injectable and oral version. 
The plan is to get the injectable version for critically-ill hospitalized patients through to the FDA drug process first, and then follow up with an application for its oral version – expected to be a much simpler process once the first approval is in hand. 
Currently, NanoViricides is working on constructing a production facility in Connecticut, where it can produce its drug candidates under current good manufacturing practice (cGMP) standards. Construction is anticipated to be wrapped up by the end of this year, after which the company will look to commission the plant, and make three batches of material under cGMP conditions. 
Once the data from the toxicology and pre-IND studies are in hand as well, the drug developer will then be able to file its investigational new drug (IND) application for the move to the clinical stage. 
Talks are underway with different facilities for the clinical trials, with NanoViricides having already inspected three facilities in the U.K., U.S. and in Belgium. The decision will be made on a series of factors including cost of the facility, availability and the cooperation of local governments.
“We’re excited about creating lots of potential cures for different viruses, but we’re focused first on FluCide. Once this is done, a path just opens,” says chief executive Dr. Eugene Seymour, who began practicing medicine in Los Angeles in the 1960s and founded Stat-Sure, which oversaw the development of a rapid HIV antibody blood test in the 1980s. “We have an almost infinite number of viral targets. As fast as Mother Nature throws us the viruses, we can make the drugs,” he adds. 
Indeed, the company says it has promising drug candidates for not only the flu, but also against HIV, viral eye diseases, Herpes and Dengue viruses. 
According to recent company statements, both drugs in its FluCide program have shown “very high effectiveness” in preclinical animal studies of three "distinctly different" influenza A virus infections, 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 has said. Untreated animals died within five days. 
“We could have made a drug for the SARS virus in a few weeks using our technology. All I needed was the antibody. Essentially, it’s using the nanomicelle as a missile with the receptor mimic as the “guidance” system," the chief explains. 
“We should be able to plug in one mimic after another once our first drug hopefully gets approved by the FDA, with one drug expected to move into the approval stage every six months after the first one is completed.”
He says there has been tremendous activity in the field of nanomedicine recently, specifically in cancer, and as a result anticipates the FDA is cognizant of what the technology entails. 
“Everybody is focused on cancer because that’s where the big money is, but I expect the new economic realities of medicine will lean more towards what we’re doing with viruses.”
The company had current assets, including cash, equivalents, collateral advance, and prepaid expenses, of $16.9 million at the end of the first quarter, which it estimates is sufficient to support operations for at least two years as well as the initial human clinical trials of its first FluCide drug candidate. 
Finding support for its drug pipeline has so far not been challenging given the current state of capital markets. It raised $6 million from three family offices and a charitable foundation in February, and announced the full retirement of its Series C convertible preferred stock held by Seaside 88.
“We have been quite frugal. As we progress along our path, the value of the company will increase so securing additional financing should not be that difficult . With additional capital, we can advance more drugs into the FDA in a shorter period of time,” says Dr. Seymour. 
He makes the point that the materials the company uses are dissolvable and biodegradable unlike other nano-materials that are toxic. “We haven’t had a problem in all the animals we have tested and we have autopsied many of them.
“We’ve got the capital, the people, the facility and the scientific advisory board. Something catastrophic would have to happen to derail us.” 
Last week, the company appointed Baylor College of Medicine professor Dr. Milton Boniuk to its board of directors, and recently added Meeta Vyas, credited as being the first Indian woman to be named CEO of a publicly listed U.S. corporation, as its interim CFO.
Its shares rallied almost 10 per cent on Monday, to close at 68.5 cents, extending year-to-date gains to nearly 50 per cent. 

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