RE:The Phase 2 False StartFantastic post! Someone did pay the price for this ROYAL FU<K UP. It appears that the woman at TLT who was previously in charge in clinical development is no longer with the company. The clinical trials are now being driven right from the top, with CEO Shirazi firmly in control of the crown jewels.
Eoganacht wrote: Two crucial mistakes were made so far in the phase 2 trial.
Of the original 12 patients treated, 4 were removed from the study because they "presented with unchanged CIS at 3 months"
This was thie first mistake. Only patients who had progressed to Muscle Invasive Bladder Cancer or those whose cancer had metastasized should have been removed. The clinical protocol has now been changed so this won't happen again. Unfortunately there are now only 19 out of the first 25 patients who might display a CR at one year rather than 23 out of 25.
The second mistake was that bladder volume was miscalculated. This led to undertreatment of the first 12 patients by up to 88% This could well be the reason 4 patients presented with unchanged CIS. If they had received an appropriate dose they might well have been CR at 6 months.
The volume miscalculation is maddening because Theralase researchers went to such infinite pains to get the dose just right, as evidenced by this June 2020 paper. But if the bladder volume is wrong, none of the dose calculations will work. Thankfully there are still many more patients to come so Theralase still has the chance to demonstrate the superiority of it's treatment.
Minimal required PDT light dosimetry for nonmuscle invasive bladder cancer Lothar Lilge,Jenny Wu,a Yiwen Xu, Angelica Manalac, Daniel Molenhuis, Fynn Schwiegelshohn, Leonid Vesselov,d Wayne Embree, Michael Nesbit, Vaughn Betz, Arkady Mandel, Michael A. S. Jewett, and Girish S. Kulkarni