Replies to post #7619 on Avid Bioservices Inc (CDMO)

[jazzbeerman]

BOT,

I agree it does seem quite possible, as does the possibility of some "undetectable" I suppose...

My 2 log 'home-run' comment was with reference to a previous post of faxorama's wondering about what the mkt would perceive as great results. I think a monotherapy 2 log would be very well received.



j

[jb_118]

BOT-

I'm fairly new to seriously looking at PPHM, but one thing that bothered me a bit is that I can't see any examples of log reduction numbers in their animal models. (I'm aware there isn't an HCV animal model.)

I don't know how to equate "lethal"/"non-lethal" with log reductions in viral titers. At all. I suspect that the relationship would depend on the antigen, the species being tested, the initial viral load and the dose of the MAB at the very least. I don't know how to relate accute hemmoragic fever lethal/non-lethal data in pigs to a chronic HCV viral titer reductions in humans.

I also don't see the connection between 70/30 chimeric and 70% effective and 30% effective. I do agree it should be at least as effective in humans, but I don't think you can quantify the effectiveness by the % chimeric, especially when the data are on different pathogens. It was 50% effective in preventing death in pigs. Would a fully human MAB be 100% effective? Maybe, but not because it was fully human.

I'm still left wondering what sort of viral titers to expect from the repeat dose study. If anybody knows of viral titers from any of the PPHM animal work I'd like to learn.

[cjgaddy]

BT, we anxiously await HepC-repeat results, but add you your comparison of 3G4/Animal Single-vs-Repeat results for Lassa this Joe Shan (Dir./Clinical Affairs) 6-7-06 comment about the IA/Single results thus far:

”Based on the results reported today [6-7-06], the drug's anti-viral potential may be even more promising in humans than the animal models suggest.”

It’s now been ~5 weeks since Peregrine said the first patient(s) were dosed in the Repeat trial. It’s been suggested (but not officially that I’ve seen) that the 1st cohort is at .3mg/kg (glad we didn’t have to start at .1mg).

As usual, fingers and toes X’d…