| | | Glaxo would not even take a look at NNVC's technology unless it has shown some proof of efficacy in human Phase 2 trials. Thinking otherwise is a pipe dream. In vitro or skin culture results presented at a conference poster or two, and never published in peer reviewed scientific journals where the data are closely scrutinized do not get the attention of big pharma or credible biotech investment house research analysts either.
Even with Dr. Moffatt's data, the actual concentrations of the nanoviricide drugs used to approximate the activity of cidofovir - the comparison drug- are not shown in any of the NNVC's graphs. In Moffatt's data the best nanoviricide tested was just about as efficacious as reducing virus as cidofovir, not umpteen times better. So how much nanoviricide drug would actually need to be applied per dose to the skin surface in shingles patients - milligrams, a gram, multi-grams? How much would each nanoviricide dose's cost of goods be versus a 1% -5% acyclovir cream, given nanoviricides appears to be chemically complex, and difficult and time-consuming to manufacture (at least from the Theracour track record to date).
One fundamental flaw in Moffatt's skin culture model of shingles virus infection is that she appears to inoculate the viruses to the skin surface at the epidermis outer layer. Shingles on the other hand is caused by reactivation of latent VZV virus in the nerve ending ganglia embedded deep in the inner dermis, not virus present at or near the skin surface. NNVC needs to show unambiguously in a peer-reviewed medical journal article that its drug candidate when applied as a cream on the skin surface actually gets to those deep skin layers and then stays there unaltered long enough to be clinically effective, rather than just clear virus on the skin surface.
Think about it. In a living human, as opposed to Moffatt's lab's skin plugs grown in a petri dish, there is active blood circulation through blood capillaries within the skin which would constantly carry away a good percentage of the nanoviricide drug after its application at each flow-through every minute (blood doesn't just sit around). So even if it the drug is absorbed into deep skin layers where the ganglia lie, it won't just hang around there near the site of application. So each application of the cream would actually need to have very high doses applied just to maintain and sustain an efficacious drug concentration in the deeply embedded skin nerve ganglia to last until the next application. So NNVC would need to show that at least 20-50 fold higher doses of the drug in the cream applied on the skin surface than needed to be effective at the ganglia can be safely applied, without toxic effects. |
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