Monday, January 31, 2011 7:46:58 PM
Dear Patricia,
No one is more anxious that I am to be able to get news out to our loyal investors
Just to give you an idea of why everything takes so long...
From the time we commissioned the upcoming HIV study until we will have results to report is about 9 months. Fortunately, it appears that we're only a month or so away from infecting the animals
Here's why it takes so long!
For example, after buying the little critters (very, very expensive), they have to wait some months for them to mature. Then you operate on them and insert embryonic human thymus in their necks. Then you wait another 18 weeks for the thymus to mature and begin to produce cells that then circulate.
Then you (the researchers) start the 45 day study by infecting the animals
Then you analyze the thousands of data points that you have collected and try to make some sense of the data and reach some conclusions
Then you write it up
We then receive the data, go up and discuss the results with the researchers and only after that, are we able to make an announcement
Influenza is a lot faster because you just have to let the animals (not terribly expensive) mature at which time you can start the 21 day study
Also, the optimization process is very time-consuming.
Do an in vitro study on a large number of different versions of the drug, select the best candidates, synthesize them, do the animal study, take the best performing candidates, optimize them, send them back to the researcher who repeats the in vitro study and off you go again into the animals
It only seems like a long time because you never have the ability to peak under the covers at a major pharma where they work for years doing drug discovery
We've done drug discovery already on 9 different drug candidates and now we're just optimizing as fast as we can
And why didn't we just concentrate on one drug and move it along? Because the technology was so new that no one actually believed it would work. That's why, to gain credibility in the scientific community (our peers) we had to show it would work as a platform. Were we successful? If you call being invited by the NIH to present at a major meeting/worksop on dengue, I say we have!
Remember that we have to bring a fully mature drug to the FDA and can't change things on the fly
And we have had to go through this process with each of our 9 candidates
In this manner, we can take the most fully actualized compound that has the best laboratory and animal data and bring that to the FDA.
And remember also, that we're at the mercy of the schedules of our partners who often have their labs and their researchers scheduled 6 months or more in advance
A true logistical nightmare
However, all you need is to get the first drug approved..or even into trials and you're golden
Most drugs (over 80%) fail in the pre-clinical period
We haven't had a failure so I'm very optimistic that things will continue to go well
I have volunteered to be the first person on whom the compound is tried as part of the safety study
Dr Barry Marshall, the gastroenterologist in Australia who was the first to both propose and prove that peptic ulcers were caused by a bacteria http://www.msnbc.msn.com/id/9576387/ns/health-health_care/
drank a concoction of the bacteria, got sick as hell and treated himself.
That changed everything that physicians had always held dear about ulcer disease (and made a lot of surgeons very unhappy)
So that's why everything appears to happen so slowly!
And that, as Oscar Wilde once wrote, "is the vital importance of being earnest"
Sincerely,
EUGENE SEYMOUR, MD, MPH
Chief Executive Officer
NANOVIRICIDES, INC
Nanotechnology-based targeted anti-viral therapeutics
http://www.nanoviricides.com
eugene@nanoviricides.com
310-486-5677
PS feel free to share these meanderings
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