The company said it has reached "a new milestone" with the start-up of the renovation of its cGMP (current good manufacturing practice) facility, which 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 clinical pipeline.
In other news, it said that on Monday an unusual pattern in the trading of its stock was brought to its attention by concerned shareholders.
"This highly unusual pattern involved selling of very large amounts of the company's common stock shares in a short time prior to the close of trading, leading to a large drop in the share price," it stated in a release Tuesday.
"The company does not have any knowledge of who the sellers were."
Shares of the company were up nine cents this morning, trading at 41 cents as at about 10:25 a.m. EDT.
NanoViricides stressed that it is unaware of any fundamental basis for the "unusual trading pattern" or the associated share price drop.
"The company has no knowledge of any business related events or of any fundamental changes in its business, programs or technology developments, that would constitute an adverse business event," it noted, adding that all of it programs are on track, and that it has sufficient cash in hand to carry out its current plans.
Last week, NanoViricides reported that with the $6 million it recently raised, and its cash position at the end of its latest quarter, it has about $20 million in hand and said it has developed a strategy to minimize its capital costs in the construction of the production facility.
With its current cash position, the company believes that it can support operations for at least two years, perform the necessary new drug application (NYSE:IND)-enabling studies for its anti-flu drug candidates and begin human clinical studies "in a reasonable timeframe".
NanoViricides' injectable anti-flu drug, NV-INF-1, is intended for use in hospitalized patients with the flu. The company said it believes it will be useable in immuno-compromised populations, and may receive an orphan drug classification for this indication.
According to the drug maker, its oral anti-influenza drug candidate, NV-INF-2, may be the first ever nanomedicine drug of any kind that is active when administered orally. This drug is being developed for out-patient influenza cases, and may also be useful for the protection of health care workers.
Both drugs in its FluCide program have shown "very high effectiveness" in preclinical animal studies, NanoViricides noted, routinely showing substantial superiority to Tamiflu, the current standard of care.
The FluCide drugs are intended for use against most types of flu viruses, including H1N1 or the "swine flu", H3N2, novel strain, and bird flu.
The 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 noted that all flu viruses bind to the sialic acid receptors, even if they rapidly mutate.
Including the FluCide program, the company said 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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