NanoViricides Inc. (NNVC)

[arvitar]

"You may recall the bird flu scare of the fall of 2005. NanoViricides was quick to announce that August that the government of Vietnam’s National Institute of Hygiene and Epidemiology had “extended an invitation to the company to help in the battle against bird flu.” That’s an odd way to describe buying clinical testing services from the NIHE labs. That September, NNVC announced FluCide-1, citing “progress in developing” the drug. The press release did clarify things with Vietnam, saying that NIHE had merely “extended an invitation to the company to discuss” fighting bird flu.

Clearly not the types to miss the chance to talk about something, the company announced its intention to go to Vietnam to do that talking, after which they intended to “redevelop” FluCide-I into AvianFlucide-I. In March 2006, they reported that the results from a mouse study of FluCide made the drug “worthy of filing an Investigational New Drug Application” with the F.D.A. Alas, it’s been eight years and not only has no I.N.D. been filed, there’s no longer any word of AvianFluicide on the company’s web site.

The press releases continue like this for nearly a decade, but the company has yet to get a single drug out of the lab. There have been no human clinical trials, and not a single I.N.D. filing with the F.D.A.

As quickly as products such as AvianFlucide have disappeared from NNVC’s roster, replacements have been added, including those targeting rabies, viral eye diseases, HIV, Hepatitis B & C and Herpes Types I and II. There’s also a “bio-defense” program they call “Accurate-Drug-in-Field,” which is a “unique” technology (aren’t they all?) that governments will be able to use to “quickly” create a nanoviricide “in the field…to stop an epidemic from spreading.” Al Qaeda thinks it can scare us with biowarfare? Pshaw! Not if we’ve got NanoViricides’ technology in our pocket out there “in the field.”

Their current front-runner is FluCide. And how far along is that? Well, they like to say that they’ve had a “pre-I.N.D.” meeting with the F.D.A. about it. Yes, they’ve had a meeting with the F.D.A. about an I.N.D. At some point, though, one would expect that I.N.D. to actually be filed, and time is a-wasting. NNVC claims that FluCide demonstrates “significantly superior activity” to Tamiflu, the best-selling flu treatment in the world. And by superior, they mean a 100x to 1,000x greater viral load reduction than Tamiflu. You should read the peer-reviewed research on it. And by that, I mean that you can’t. Because there isn’t any.

Let’s just suspend a legitimate skepticism, though, and assume that they’re actually serious about developing drugs. For all its claims about breakthrough technology, NanoViricides is woefully short on the kinds of progress—and proof—that one usually sees out of development stage. Another company, Bind Therapeutics, is promoting a similar concept called Accurins. But unlike NNVC, Bind has a drug in Phase 2 trials, as well as collaborations with large pharmaceutical players. Bind has a ton of patents and published papers. A search of Pubmed shows no published papers describing any of the pre-clinical work supposedly done by NNVC in the near-decade of its existence.

ONE THING NNVC CAN STAKE A SERIOUS CLAIM TO is the ability to raise money from credulous investors. The statement of shareholders’ equity in the company’s latest 10Q filing is the size of a Russian novel. Which, as they say in the trades, can also be a red flag.

They raised $4.3 million in October 2009, at which point they said they had enough capital to get through year-end 2010. They filed a shelf registration in March 2010, though, and then raised $5 million more before year-end. But then…in April 2011, they raised another $5 million. In October 2011, the company said it had sufficient funds to advance its drug pipeline “further into the [F.D.A.] approval process”—a curious characterization, considering that none of their drugs have ever entered the F.D.A. approval process, and then, surprise!—three weeks later they announced another $5 million raise. And another $5 million in June 2012. In February 2013, another $6 million—enough, the company said, to fund the initial human clinical trials for FluCide.

In August 2012, the company announced “success” in “developing” an orally ingested anti-influenza drug candidate. Said NNVC: “We believe this may be the very first targeted nanomedicine that is available via the oral route. Oral availability of FluCide would open up a much larger market than the injectable version.” The injectable version of what? FluCide? It shouldn’t be that hard to open a much larger market for a drug for which there is no market as yet. Not only that, one can only assume that NNVC has never heard of FluMist. It’s been around for years, and 13 million doses of it were administered in the U.S. this past flu season alone. That market is already, shall we say, “opened up.”

In September 2013, they raised $10.33 million, the largest contributor to such being wealthy ophthalmologist (and NNVC member of the board of directors as of May 2013!) Dr. Milton Boniuk. Not included in the announcement was the fact that NNVC had been paying Dr. Boniuk’s sister, Vivian, a 73-year-old ophthalmologist in Great Neck, N.Y., to do preclinical work in animal studies for a conjunctivitis drug. In other words, NNVC hired the sister of one of its board members to do clinical work that she clearly does not specialize in. She has not published a single paper about any of these animal studies.

In January of this year, they raised another $20 million, which, they said, will get them through Phase I and II of human clinical studies for their injectable FluCide drug. (The oral version, it seems, will have to wait, despite the “much larger market.” Priorities, people!) And on it goes. All told, this company burned through $46.3 million in cash by year-end 2013 with not a lot to show for it. NNVC recently claimed they had enough cash to get them through Dec. 31, 2015. Let’s see if they make it that far.

DID I MENTION THAT IN THE FIRST SEVEN YEARS OF its existence, the company failed to hold a properly-noticed meeting of shareholders for the purpose of electing directors?

Or that in mid-March, they put out a press release denying a rumor on website Seeking Alpha that an unknown acquirer had valued the company between $2.25 billion to $4.5 billion? The numbers were patently absurd, and the same afternoon, I was compelled to issue my own press release denying the persistent rumors that Scarlett Johansson and I have been secretly dating.

have any idea if any of Nanoviricide’s drug candidates do hold any legitimate promise. Of course, no one else does either, as they’ve published no papers on them, and they’re hasn’t been a single FDA trial of anything they make. Or will never make. It all brings to mind a certain song lyric: “The only thing we knew for sure about Henry Porter was that his name wasn’t Henry Porter.”

“Our drug development costs have been substantially lower than industry standards so far because of our rapid drug development platform technology,” says NNVC. By my understanding, drug development costs are best measured once a drug has hit a milestone such as F.D.A. approval or, barring that, entry into F.D.A. trials. None of NanoViricides’ drug candidates have hit either. Considered in that light, my own development efforts for a flu vaccine are as far along as theirs, and I haven’t spent a dime. All I need now is a Real Housewife of Beverly Hills, and I’ll be ready to save us all. "

http://observer.com/2014/04/west-havens-nanoviricides-has-big-goals-and-big-problems/