Avid Bioservices Inc (CDMO)

[Protector]

nuke, this is Bavituximab's latency problem again.

SK - Part of the problem was that viral moves so fast. Based on our current knowledge of the mechanism of action we can apply it differently now.

What does this mean 'MOVES FAST' if we are talking about a virus? It means proliferation through the body. And how does proliferation translates in biology terms? Infected cells and potential harmful floating material that is able to further affect more cells.

Now translated in the realm of bavituximab this means PS (Phosphatidylserine) is exposed at very HIGH RATES compared to PS exposure in tumours. And it is more then just that.

While with cancer cell damage we have exposed PS still attached to the cell and micro-vesicles containing PS and floating in the blood stream, with viral we have THAT PLUS some other forms of PS exposure which places bavituximab seriously in the disadvantage, hence its latency.

The first one is viral material that has touched PS inside the cell and re-enters the blood stream while being, lets use the word TAGGED, with PS. It masks the virus from the MDSC's and macrophages BUT ALSO increases the total amount per volume of exposed PS in the bloodstream.

Secondly there are different kinds of cell destructions when the virus manages to copy its code into the DNA strings. It has been discovered that actually the cell can undergo extreme large damage resulting in lots of cell debris (from the cytoplasms) but of course also PS from the membrane that starts floating in the blood. Here again the total amount of exposed PS is increased and actually in several cases increases dramatically.

As of there it works like an avalanche. More healthy cells get infected more rapidly as the immune system gradually gets more and more suppressed and is less and less able to even slow down the proliferation.

Ebola is one of those very rapidly proliferating viruses that gets the help from an army of PS molecules to keep the immune system police (macrophages, MDSC's) in the dark. With Ebola the rapidly progressing cell damage even becomes visible on the outside.

The solutions is again DOSING. goodJohn had already in the past brought up the topic of dosing in relation to oncology applications where indeed smaller but higher frequency bavituximab (posible after an initial big shot) might improve results (and I add that combined with lowering chemo dosage which I believe to be the basis of the side-effects that in the end might kill the patients would work even better). Actually a virus has a kind of comparable non-targeted body-wide damage profile as does chemo.

In viral one can, based on the above explanation, clearly see that the Bavi army must be LARGE and CONTINUOUSLY present. Large for the obveous reasons, the virus is not like a tumour contained to a specific local location but hits body wide (as does chemo :) and continuously because it is clear that such rapidly proliferating viruses need only a VERY SMALL time window of absence of bavituximab to take the upper-hand. This makes treatment in the field, certainly in low hospitable and hostile environments that soldiers are in (DTRA interest) difficult. For them you want a vaccine. In hospital environment all that can be easily set-up.

But it gets worse, at least for field treatment.

Since with such high and frequent Bavituximab dosage treatment we are talking about an IMMENSE Immune system activation the patients will need a lot of ENERGY. SO the normal symptoms of fevers, headaches and all other tricks the body plays on us to get us to rest/sleep and not consume energy will be present.

However, IMO, this will NOT suffice. One will need to provide a LOT of water (fever cooling and replacement from sweating) and high energy drinks/nutrition or even better and faster infuses to allow the immune system to fabricate its killer cells army. That is we must provide the CLAY and the ELECTRICITY to build the army otherwise or working force is USELESS.

What I say is that one must make the difference between the immune system keeping us from spending energy and the amount of energy that is available to spend. If it is not there then Bavituximab may activate the immune system at the systemic level as much as wanted, if there is no clay to make your terracotta soldiers there will be no army, although all other conditions are met.

I suppose PPHM looked deeper into this latency, hence inciting CEO King to make the statement below.

Based on our current knowledge of the mechanism of action we can apply it differently now.