ASM partial notes (due to weather issues, I missed the first 40 min of presentations)
2014 goals;
- Sheldon facility will be ready 1Q14
- Regarding the IND required studies, 5 have to be in vivo (INCL 4 Infl A:H1N1, H5N1, H7N3, H7N9, + 1 infl B), 16 can be in vitro.
Note: have been approached by pharmas but none are interested at this stage. No appetite for risk, even if more cetainty will cost them 50X more.
Dr. D presentation:
- For FDA, focused on efficacy -> 5-6,000 animals tested so far.
Q: By what factor are viruses overtaken? A: There are over 75trillion viricides in a teaspoon dose vs a few hundred million viruses, eventhough the viruses have the ability to replicate.
Q: Main holdups at current stage? A: The chemistry is under control. 2 main holding points: 1- a large scale manufacturing facility, which will be ready 1Q14 for the IND-needed material (by the way, contacts are already being established for subcontracting future large scale production needs). 2- The quantity of material needed for conducting the pre-INDs: because of initial low toxicity shown, the quantity needed for pre-INDs will be superior to the quantity that will be needed for Phase II!!
Q: Evaluation of the scale for the Max Feasible Dose? From 100x to 1000x the therapeutic dose!
Q: Any materials delay at this point? A: No, materials are not holding up at this point. Lack of qualified manpower is. It's VERY difficult to find candidates with both the chemistry knowledge and biology engineering background required. No time to train candidates that may leave once up-to-speed...
Q: When in discussion w/ FDA, has NNVC discussed alternative end-points? A: Viral load was discussed but no conclusion were drawn yet.
Note: Amongst interested parties, NNVC met with the Gates foundation, but contact has been interupted based on requests to get rights to the IP.
Q: Will there be need to get some tests on primates? A: One of our British partner wanted to use them but based on availability of small animals - mice - with humanized immune systems, NNVC recommends using those as they require less material and are as acceptable. BASI uses small canines and rats for their tox testing.
Dr Diwan: What was just presented to you could be called a Gen.I viricide, which action mode is extra-cellular. Be aware that we have plans for Gen.II which would complement the Gen.I, working intra-cellularly, for extending the types of viruces that could be adressed by this technology. This would not be a huge step for the company and adds a serious additional weapon to the arsenal. Very important tactically vs. nepharious pharmas.
Q: Timing of Denguecide vs Flucide? A: probably about 2 years behind.
Finally Dr. D. finished his presentation with a quick description of the Accurate Drug in Field technology, which could be a way to get some treatment vs viruses in a matter of about 3 weeks, when it takes vaccines no less than 6 months to be developed...
Overall, I found this meeting to be of higher value than last years, with excellent questions from a growing audience, despite the bad weather.
2014 should be a fascinating year!
GLTAL
AR.
