RE:RE:Isolated data on the optimized group I would also add that a sub therapeutic dose followed by a therapeutic dose 6 months later may have contributed to the NR. Swift & thorough cancer eradication is key in preventing cancer resistance, which highlights the importance of proper dosing, number of treatments & timing of treatments. The sub-therapeutic dose that had been given may have not only "partially" treated the cancer, but may have potentially encouraged the growth of both treatment sensitive & treatment resistant cancer cells...all imo. If this were the case, the timing of a subsequent optimized treatment may come more into play. Just thinking out loud, but perhaps an optimized treatment administered earlier (before 6 months) for this suboptimally treated group (or even two optimized treatments subsequently administered) may have led to a different result. I think over time & with additional experience/study, the ideal treatment time interval/density of treatments for a given cancer (especially for a resistant or stubborn one) will continue to evolve for the better. Good luck...
Eoganacht wrote: Hi ScienceFirst - I'm nit-picking here, but only 4 of the first 12 patients received an optimized second treatment. I believe one eligible patient of the 5 opted not to remain in the trial. The fact that these 4 patients ultimately ended up NR, despite their single optimized treatment, demonstrates the wisdom of treating each patient twice.
From the Nov 27, 2020 MD&A
"Study II has enrolled and treated 12 patients as of September 30, 2020. Out of the 7 patients that are eligible to receive the second treatment, 5 have been treated and 2 are pending. 2 of the 5 patients treated for the second time have been treated with the optimized Study II treatment, which will also be the case for the 2 patients that are pending their second treatment."
ScienceFirst wrote: April 22, 2022, TLT produced a separate chart for the optimized group. See "
Study II Clinical Study Data (Optimized: Post August 1, 2020):"
Assessment (Days) | Complete Response (“CR”) 2 | Partial Response (“PR”) 3 | Pending 4 | CR (Evaluable Patients) 5 | Total Responders (CR + PR) 6 | Potential Responders (CR + PR + Pending) 7 |
90 | 52.2% | 17.4% | 13.0% | 60.0% | 69.6% | 82.6% |
180 | 22.2% | 18.5% | 40.7% | 40.0% | 42.3% | 83.0% |
270 | 14.8% | 3.7% | 59.3% | 36.4% | 18.5% | 77.8% |
360 | 3.7% | 7.4% | 66.7% | 11.1% | 11.1% | 77.8% |
450 | 3.7% | 3.7% | 66.7% | 11.1% | 7.4% | 74.1% |
Take into consideration this passage below of July 30, 2020, as it seems to confirm that p# 8-9-10-11-12 might be considered belonging to that optimized group and if so, could have prevented us to reach close to 100% as it seems that they ended up being NR @450-days. So if we would have excluded them, we could certainly have had higher efficacy %. That's why the data on August 30 on the 11 pending ones is so important to try to see through the data.
July 30, 2020:
Theralase Reports on Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC”) Clinical Study (“Study II”) Progress – Theralase Technologies ...
Study II enrolled and treated 12 patients Study Treatment Optimizations:
Additional optimizations to the clinical study protocol that have been implemented for all future patients to be enrolled and treated in Study II and for the five patients yet (so p#8-9-10-11-12) to receive their second treatment