RE:RE:RE:RE:RE:Dose Escalation QuestionIs there anything that prevents the doctor from Gettysburg providing an update on patient 1 or other patients? Some type of legal agreement where he is restricted in what information he can share? It seems based on the past report the doctor is not shy sharing updates and if things were going absolutely fantastic and he was at liberty I wouldn't be suprised to see another update.
SPCEO1 wrote: I am not super familiar with how other companies handle this, but you can be sure different companies do it differently. CYDY will no doubt put out a press release highlighting that their first TNBC patient brushed her teeth this morning, therefore she is alive and you should buy their stock. TH has always been at the opposite end of the spectrum when it comes to disclosures like this and I am not saying that is totally a bad thing. But TH could loosen up some. On the cancer phase I, I am told they are reluctant to say anything because the patients receiving their drug are already very sick and could easily pass away in the midst of the trial. So, they don't want to be heralding any aprticular patient when said patient might not be with us much longer and when their drug could more easily and inaccurately be blamed by investors now paying close attention to that patient due to the company's PR, for that patient's demise if they did sadly pass away sooner than hoped.
Company's like to control trial data, even when it is an open label trial, so they can position it optimally to the financial markets. That typically means that they wait until the last moment to gather as many facts as possible before releasing exactly what they want to release about it. And since TH is already cashed up follwoing the OO, the incentive to release good info early is not there now.
So, knowing TH, don't expect a flurry of daily press releases updating the condition of the patients in the pahse I.
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."