RE:RE:RE:RE:RE:RE:RE:RE:RE:$tltff The FDA wants an option that has rates better thentdon1229 wrote: CancerSlayer wrote:
2b7f6fab wrote:
The kil rate in vitro seems to be 100%. Why aren't we seeing that in actual practice. I'd like to see the solution that comes out of the bladder at the end of the procedure to be collected and analyzed for potency. This could give us clues as to why there isn't a 100% CR.
You make a good point...it would be valuable information to see what the concentration of that used solution would be. Unfortunately, in vitro doesn't always translate perfectly. Considering the human bladder isn't a perfectly flat/smooth surface (kind of mimics the WWI trench landscape wherein many cancer cells are hiding at the bottom of the trenches), the actual TLD 1433 dose or concentration within each cancer cell (& within each patient) likely varies.
The standard laboratory wisdom is that you can kill almost anything in vitro with strawberry jam. That's just one of many reasons clinical trials are performed.
As for Theralase's treatment, if the trench analogy applies, then not only must the TLD-1433 reach the cancerous cells in order to be absorbed, but also the green light has to shine into those trenches with adequate power density and for the proper time duration to enable the TLD-1433 to enact its cancer killing effects.
For some idea of the difference it can make, note the results of the undertreatment of those first 12 patients in this Study II trial.
Good point...because of the bladder folds/rugae, there is the potential for variation in the dose of both drug & light. Perhaps down the road, use of systemic Rutherrin can help maximize or achieve a more accurate drug dose? And perhaps in the future alternative/additional activation techniques can be employed?
In the meantime, I'm extremely happy with how we currently compare to the existing single-agent treatment options. It's comforting to know that in evaluable patients, our 450 day CR currently exceeds that of Keytruda's (25% vs 19%), & that 25% includes data from the underdosed 12 in study II. There's a very good chance that our durable response rate will at least be maintained & likely rise as more patients undergo two fully optimized treatments.
I predict CRs/durable response rates will continue to rise as this ACT gets further nuanced/refined in the coming years. The most important thing to me is we seem to have the key to curing this devastating disease in a subset of patients...the key will simply be getting polished now & then to help unlock its true potential. Good luck...