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. The drug could potentially be used as well in a doctor's office for the treatment of less serious cases.
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.
Its FluCide drug candidates have already shown what the company calls "strong effectiveness" against H1N1 and H3N2 flu viruses in animal studies, with 100 to 1,000 times greater viral load reduction than the current standard of care known as Tamiflu.
The $6 million it has raised announced today came from four equity investors, including three prior family office investors, and a charitable foundation.
The company now reports having around $19 million of cash in hand with the recent raise, which will last it through the first human trials of FluCide.
"These family funds are sophisticated equity investors that have always shown a strong faith in both the NanoViricides(NYSE:R) platform technology and our unique vision," said CEO Eugene Seymour, in a statement Monday.
"With these new investments, they continue to be long term investors in NanoViricides, Inc. We are extremely pleased with their continued support."
The investors bought unsecured convertible debentures with a four year term, bearing an annual interest rate of 8%m and additional interest payable in restricted common stock and warrants. They can convert the principal and any accrued interest into common stock at a fixed price of $1 per share.
The company said it believes that its FluCide drug candidates will be effective against most, if not all, flu viruses, including H3N2 or H1N1, seasonal flus, bird flu and new flu strains.
This is because 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.
NanoViricides has already conducted a pre-IND meeting with the U.S. FDA for its injectable anti-flu drug last March. It is now working on studies needed for the investigational new drug submission.
Last month, the company hired AES Clean Technology to design, engineer and construct the "cleanroom suite" for its laboratory and cGMP pilot production facility project.
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 clinical pipeline.
Aside from the flu drugs, the company is also developing drugs against HIV, viral eye diseases, Herpes, and Dengue viruses. Its share price rose on the back of the news Monday, by 0.6%, to 48.3 cents.
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