RE:RE:Misdiagnose??? Newswire April, 16, 2018...
Theralase said (QUOTE) '' The company, in conjunction with its clinical partner (UHN) have '' OPTIMISED '' the clinical procedure of the study commencing with patients number five'' (END OF QUOTE).
Optimised = modify to achieve maximum efficiency.
Glance at the highlight in the two post below...if optimisation is done properly, we could be in for pleasant results before the start of the phase2 trial.
enriquesuave wrote: Awesome post Wildbird. I was thinking the same when I thought of the exclusion criteria. They for sure would not have misdiagnosed 4 on 4 patients. They were probably included in trial to gain as much information as possible in order to design a proper PH2. They now know that one single instillation of even low dose TLD-1433 produces 100% tumor destruction, but not enough of an immune response to target sites outside Bladder like the ureter and to prevent recurrence. But that was also pretty much known as well since it takes 2-3 PDT sessions to produce a potent enough immune response especially since TURBT was done prior. So they must feel confident that non UUTUC patients will probably be tumor free for much longer periods and may require only 1-2 treatments and UUTUC may require slightly more treatments 2-3 or 4 to produce enough of an immune response to prevent further recurrence. IMHO. With this valuable information, they will design a clad proof PH2 which will allow them to establish a protocol for non UUTUC patients as well as one for UUTUC patients who may also require their new vaccine. Who knows.
They (the doctor) know what they are doing as it's not the first time they are working with PDT trials. wildbird1 wrote:
Safety & tolerability (first 4 patients).
If you take the time to read the TLD 1433 Clinicaltrial. gov site.
Inclusion, exclusion criteria for the Phase1 trial...
No 8, criteria (QUOTE) Have no evidence of Upper Urothelial Carcinomas (involving the Upper Urinary or the Urethra) (END OF QUOTE).
Meaning...In the phase1 trial TLT and UHN were permitted to screen out UUTUC patients (patients that have cancer cells outside the treated area).
The big question is???
If UHN was permitted to screen out UUTUC patients, how did we end up with the first 3(4) patients having recurrence ...possibly caused by UUTUC patients.
Were these 3(4) patients misdiagnose???
Very unlikely for a team of highly qualified PHD scientists from UHN to misdiagnose 3(4) UUTUC patients in a row.
The answer ''could'' be...
1- No..they were not misdiagnose.
2- At this stage in the phase1 trial, screening out the UUTUC patients was not the priority, the priority was on proving '' Safety & Tolerability '' on the low dose patients (1,2,3 ) and the high dose patient (4).
3- You always try to test '' Safety & Tolerability '' on the worst of the worst patients (UUTUC).
UHN used these 3(4) patients to find out about '' Safety & Tolerability '', in addition UHN might have used these 3(4) patients to find extra data on UUTUC and extravesical recurrence. (like finding two answers with one action).
These data will be priceless for the Set Up of the phase2 trial.
'' Endpoint of Efficacy '' (last 5 patients).
There is a possibility that the last 5 patients might be used to find out about '' The Efficacy Endpoint ''.
If that is the case with all the informations gained on the first 4 patients, rest assured that TLT & UHN will be very meticulous in screening out patients that have extravesical disease..(UUTUC patients).
PS: Assuming that patient no4 was used to find out about ''Safety & Tolerability'' on the high dose patients, whether or not patient no4 has recurrence is '' Irrelevant '', the focus is exclusively on the last 5 patients.
If the screening process is done properly, will be interesting to see how long the last 5 patients will stay recurrence free (the mice that didn't have cancer cells outside the treated area and no metastasis, were 100% recurrence free.