RE:RE:RE:RE:Great presentation in Oncology Yes, but only that fact surrounding them not seeing the drug accumulating in the patients blood plasma. So it seems to indicate off-target drug release is very low (1 fact we need to account for now) and that the PDC is not degrading in the bloodstream so is going somewhere to release that drug (2nd fact we need to account for now). My unscientific mind says this may not preclude one of the issues we list as to where the drugs going -- and that is down the toilet within an hour.
But that clue and what Canadapiet mentions -- that some of a couple patients may have now been on it for a while -- helps to understand where we are.
If I couple this with PL stressing once again that some cancers really overexpress it (100% for Melanona's, hence why we will need to add that in the mix, maybe even for the basket trial), and some don't, leads me to think they definitely had some that they don't think overexpresses it much at all but they had to take them. Another reason why he downplayed the timeline and if they'll get the kind of efficacy signals they want to discuss or they'll just wait for the extension. It sounds more and more likely that they are going to revamp what is in that trial or maybe enlarge it some to really get data on some of those other tumor types.
I did not see anything negative at all in this new presentation, more confirming notes around where we've all been guessing, including Palincs view on NASH interest. Although, Paul did say he knows how long those kind of discussions can drag on. Sounded like they may be in touch with some of those other types of creative financing options for $50mil -- the loans against royalties or secured with payoff schedules further out.
palinc2000 wrote:
This is what I heard also!!!
It is now a Fact!!!!
Wino115 wrote: No free docetaxol - seeing the same in humans as we say in preclinical. There's that very clear statement.
Wino115 wrote: Need to look at that slide again but appears they are now up to that 2x normal dosage level (420) after the SAE 2 and need to get 3 patients at that level with no DLT to move to the next one that is 30% more drug. It seems they've gotten there with minimal patients (9) which while that sounds slow, actually means they've been able to move up each level with just one patient because there was no SAEs. In other words, they haven't had to use that 3 patient level until this 420 level. So that's actually good.
It did appear he's talking down any efficacy signs and I can understand why now. They may actually get to the DLT or their targeted level with 15 or less patients. The good is that this means they didn't have a lot of SAEs setting them back such that they needed to move ahead with the 3 patient levels and have moved quickly into those high dose levels. The bad is they got there with so few SAEs that they used the minimum number of patients. The range was 15 to 25 and looks like they'll be closer to the 15. Obviously this means they wont' have a lot of a population to monitor for efficacy but I would guess the ones from 1.5x on they are scanning and getting that. Seems they'll hit that MTD soon though. It may actually be literally end of year if they go up one more level though and his mentioning end 21/early22 seemed to incorporate if they decide to take it up one more level or maybe even two more levels. So while not getting a year end update is a negative, it means they would be seeing a huge, huge dose that would increaes efficacy even more. That's my quick read.