Twigman7The FDA are obviously happy to let IVX dose at 300mg....

Twigman7
The FDA are obviously happy to let IVX dose at 300mg. They have approved. This approval will be based largely on results of animal trials. These were done in the old CBio days. I believe that they were not able to get any toxic reaction no matter how high the dose. These trials require that the dose be increased to find what dose is fatal. In the case of CPn10, I believe all animals died of protein overload and they could not produce death from reaction to CPn10. The dosing to 300mg will simply allow trials to this level. Given previous results of dosing at low levels, a lot of people will take the small gamble that these very large doses will have a substantial clinical effect, particularly now we have a mode of action endorsed by highly reputable researchers. I suspect that the small scale of the trial is because that was all the drug that was available. I understood from the old management that the supply of drug was exhausted and that a campaign costing about $5M was necessary before more trials could take place. It would seem that the new management has somehow managed to scrounge enough drug to do a small trial and has chosen to ramp the dosage up to prove safety at a very high level. In one presentation they have mentioned some sort of a bridging study to IV but nothing more till "partnering". This would seem to imply that the barrel is now really empty.
It is certainly true that it is harder to get positive results from a small trial, but I guess they do what they have to do. I would guess that this trial is as much designed to demonstrate the safety of very large doses to potential partners as it is to prove anything about Lupus. The paper on DAMPs, RAMPs etc. changes everything.