inShare Pdf NanoViricides' FluCide anticipated moving through FDA process shortly

NanoViricides (OTC:NNVC) is a company that holds more than one promising clinical development programs under its belt, with its most advanced - FluCide - set to undergo FDA scrutiny in an upcoming pre-investigational new drug (IND) application meeting in March.
The company's stock has gone up 13.7 percent year-to-date, currently changing hands at around 70.5 cents.
The drug development company makes anti-viral therapies using nanomaterials for a number of viral diseases including seasonal influenza, HIV/AIDS, oral and genital herpes, and the Dengue virus, among many others.
Currently, NanoViricides has five drug development programs within its pipeline, including FluCide, a drug that works against all forms of influenza such as seasonal and epidemic flus, and HIVCide, a drug that works against the HIV/AIDS virus, which the company says could become a "functional cure" for the disease.
FluCide
FluCide, which has the most clinical data of all of the company's potential drugs and is therefore being advanced through the FDA process first, works on the same principles as the rest of NanoViricides' platform.
CEO Eugene Seymour said that FluCide will encounter the most scrutiny from the company's drug platform, as it represents a new class of drugs, and is "essentially the only real treatment for patients hospitalized for the flu including  the immunocompromised like post-transplant and cancer patients".
Indeed, when elderly patients or immuno-suppressed people pick up the flu bug, they often become critically ill, leading to hospitalization in most cases, particularly if the virus is of a pandemic nature like the H1N1 swine flu, explained Seymour.
The drug candidate has been tested in animals against a number of different strains of influenza A, which comprises the majority of flu infections, as well as against H1N1 swine flu, H5N1 bird flu, and other strains.
FluCide's ability to work against a host of flu virus strains is a major consideration, added Seymour, as every year there are many different mutations of the flu. In the US alone, there are approximately 250,000 severe influenza cases that require hospitalization every year, resulting in approximately 40,000 deaths.
"Both vaccines and prior immunity look at a very narrow spectrum. If the virus in question of the season is different even in a small way, circulating antibodies from the prior strain will not recognize the new version.
"The yearly preventative vaccine often doesn't reflect the nature of the circulating virus. Health professionals can estimate what the strains will be, but they were wrong last year with the two strains that were put into vaccine," said Seymour.
FluCide is not a vaccine, but rather a therapeutic drug, as it actually destroys the virus as opposed to improving immunity to a particular disease.
Seymour said that the world is expecting a flu pandemic, and though it is not known when this will happen or what the specific strain will be, it will pay off to be prepared.
In a pandemic emergency in the US, the government has a program called "emergency use authorization", which means that if a drug has completed Phase I/IIa safety and efficacy trials, and it is manufactured under current good manufacturing practice (cGMP) conditions, then the government is eligible to buy the product to treat people with the current circulating strain of the flu virus.
"That is why we are pushing now to get FluCide into human trials as quickly as possible," added Seymour.
To fight the flu, the company uses NanoViricides, an agent designed to fool a virus into attaching to this antiviral nanomachine, in the same way that the virus normally attaches to the receptor proteins on a cell surface. Once attached, the flexible nanoviricide wraps around the virus and entraps it, and in the process, the virus has its protective envelope breached. The virus is therefore neutralized and effectively destroyed.
Seymour explained that every virus needs a target cell to enter and replicate within the body, with the small attachment peptide on the surface of the virus attaching to the cell's receptor protein.
But the company creates a nanomicelle comprised of polymers used for many years in the body, and then a peptide, or a protein, is added that mimics what is expressed in the target cell - creating a nanoviricide. The body is flooded with many more of these nanoviricide cells than target virus cells, helping to trick the virus.
The company's CEO said he believes that one infusion of the drug over a period of a few hours should do the trick, but this has yet to be tested in humans. So far, the drug has been tested in thousands of animals, without having a failure, he continued. Results have showed effectiveness in inhibiting the cycle of infection, and the spread of the virus, as well as long-lasting effects after drug use was stopped.
In May of last year, the viral drug company reported that its FluCide drug candidate reduced flu virus levels by 1,000-fold in an animal study with mice, as compared to the infected untreated control animals, the company said.
Mice treated with Tamiflu, the standard method of treatment, showed less than a two-fold reduction in lung viral load, a measure of the amount of infectious flu virus, at the same time point.
More importantly, two of the three FluCide drug candidates tested maintained the reduced viral load at 7, 13, and 19 days after virus infection in the 21-day long study.
For the study, a fatal quantity of virus particles of influenza A strain was aspirated directly into the lungs of mice. Treatment with either FluCide or Tamiflu began 24 hours after infection.
Previously, the company also reported that the same three FluCide drug candidates achieved significantly increased survival rates of between 20 to 22 days, and more than 95% reduction in lung inflammation.
NanoViricides said it still has to perform toxicology studies for FluCide, required for the FDA to move forward.
Seymour said that the company expects to start these trials just after the pre-IND FDA meeting takes place, which is expected in the next four to six weeks.
The FDA is anticipated to give guidance on the types of species to be used in the study, and how many animals are necessary within each species group, said NanoViricides' CEO. The preliminary meeting will also review the company's plan for conducting human clinical trials needed for approval.
Once FluCide is on its targeted FDA path, NanoViricides expects its other nanoviricide drugs in the pipeline to follow, with one expected "every six months or so".
Just this year alone, the company is awaiting results of new animal studies testing its drug for genital herpes, as well as animal trial results for herpes of the eye, and the Dengue virus.
HIVCide
Its HIVCide program, which is again based on the nanoviricide platform, is also creating buzz, with a potential $21 billion addressable market based on 2013 estimates. NanoViricides has said that its drug has proven to be a "functional cure" in two large studies, meaning that although there may be some residual virus left, the amount of virus is not enough to make it contagious or cause illness, Seymour said.
The company used animals with a “humanized” immune system for the HIV trials as embryonic human thymus cells were implanted into the target animals. Effects of the HIVCide lasted at least 30 days after therapy was stopped.
Last July, NanoViricides reported that HIVCide achieved an efficacy level equivalent to a highly active anti-retroviral triple (HAART) drug cocktail in an animal study. The three drug-combination used for comparison is one of the current therapies recommended for patients with HIV.
Although a functional cure is not a complete cure, it would allow an infected person to continue normal life even after discontinuation of therapy, maintaining undetectable viral load until a recurrence.
Seymour said that the worse case for this program is to treat patients with HIVCide for a few days, and then give them a booster "every few months", with the best case enabling antibodies from the recovering immune system to knock out the residual virus.
Indeed, by knocking the amount of virus down so low both in blood circulation and in the lymph nodes, immune system cells could potentially be allowed to recover, and make antibodies to destroy the remaining amount of virus.
"An outright cure would be everybody's dream," insisted Seymour.
The company still has to test the HIV drug in human trials, which is a "complex and expensive issue", said NanoViricides' CEO, meaning it will likely need a partner.
"That is why we are going for the low-hanging fruit at the moment, so to speak - such as herpes, dengue and flu - which the world definitely needs."
New cGMP Manufacturing Facility
NanoViricides, which has a cash position of around $14 million, has also taken steps to ensure cGMP manufacturing of drug candidates, with limited capital costs to the company. It is planning to begin the refurbishment of a new 18,000 foot square facility in 2012 in Connecticut, where the company will design, order and install a cGMP manufacturing plant.
The drug developer has already announced that a colleague will guarantee all the loans necessary for the refurbishment and the construction of the plant, as well as the necessary equipment, allowing it to start producing samples of its drugs and ensuring consistent production.
Human trials for FluCide are expected to start next year, depending on how fast the manufacturing facility can be ready, Seymour concluded.