RE:RE:RE:RE:RE:RE:RE:Dose Escalation Question Unfortunately the bloom burton presentation is gone now (another aspect of the company really not caring about their messaging) but I believe what he said was the 2nd dose had happened earlier that week or the previous week (I forget which). I think when I tried extrapolating back it seemed to fit the right timetable (1st dose announcement 23rdMarch). The person talking about the 3rd dose is probably one week ahead of things, my estimate is sometime next week for the 3rd.
SPCEO1 wrote: That is correct Qwerty. Someone earlier said something about a third dose but Paul said it was a second dose.
Has it seemed to take longer than expected to put the second dose into the first patient? If so, does anyone have any theories as to why it took longer than three weeks to administer the second dose?
And does anyone know how many doses the first patient will get before the second patient is dosed? When should we expect the second patient to be dosed?
qwerty22 wrote: I believe Paul said at that recent investor conference that the 1st patient had just received their second dose. Those types of off the cuff statements until something material happens would be fine with me.
Reality I think it's unlikely they give us a running commentary of each patient.
Wino115 wrote: I've never seen it for every patient, but sometimes companies will provide updates with regular quarterly updates or when some meaningful target is reached, like "all-filled", or last patient for the Phase 1 reached, etc... Maybe they'll be more proactive in their quarterlies with broad trial updates, but don't expect hard data until end of Part 1. I wouldn't mind just knowing they've continued enrolling, but not sure how to know that unless they update market.
realitycheck4u wrote: Is it typical that news of each new patient is actually released or known?
Wino115 wrote: Got it - so they all escalate, but never higher than the newest patient's dosage. So if we have no Patient #2 yet, the Gettysburg patient is still at the original dosage level. I guess we don't have a way to know if anyone else has enrolled except if the company gives an update. I would have thought it wouldn't be hard to identify possible patients given it's a refractory cancer all-comers. But still don't see it in MD Anderson list.
juniper88 wrote: Patient #2 will go to the next higher dose. Patient # 1 will never go higher than patient #2. Both will continue to go up as the trial proceeds.
Wino115 wrote: Simple question on Patient #1, do they escalate the dosage for each patient or do you keep the dose constant for each patient, so Patient #2 will get the higher dosage while Patient #1 sticks at the original dose level?
From the description, it looks like the former but it's not entierly clear the way it's worded. So Patient #1 if he passed the exam, got a higher dosage for his second round. Patient #2 will start at the same beginning dose and then also escalate. Is that correct?
From the clinical trial site:
" Dose escalation by dose-doubling will be done for the first 2 dose levels, followed by a modified Fibonacci dose escalation scheme (i.e. dose increases of 67%, 50%, 40% and 33%) thereafter for each dose level. Patients in Part 1 will be observed for 21 days post Cycle 1 Day 1 drug administration for dose limiting toxicity (DLT). Dose escalation to the next dose level will proceed following satisfactory review of safety data until the MTD is reached. The MTD is defined as that dose-level at which ≤1 of 6 patients in a cohort develop an emergent DLT."