RE:RE:RE:RE:$tltff The FDA wants an option that has rates better thenEoganacht ... Great post.
Very interesting that you bring back Photofrin's 1990 data, given that it was also with PDT and the fact that TLD-1433 is superior to it, and that we have all the other things (dosimetry, etc ...) also improved. Our treatment also protect the bladder wall, contrary to Photofrin. That was key to move forward.
Things are looking great for Theralase.
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Eoganacht - (4/12/2022 5:25:34 PM)
RE:RE:RE:$tltff The FDA wants an option that has rates better then
That's better than the (Keytruda superior) CR results of the1990's photofrin trial of 36 patients with CIS who received a single pdt treatment. More importantly, TLD1433 doesn't have photofrin's side effects.
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At initial clinical evaluation at 3 months 58% of the patients had a complete response as indicated by negative cystoscopy, bladder biopsy and urine cytology but in 42% treatment failed. At a mean followup of 12 months (range 9 to 48) 10 of the 21 complete responders had recurrence for an overall durable response rate of 31%."
https://pubmed.ncbi.nlm.nih.gov/9628601/ Photofrin was approved in Canada in 1993 but wasn't used much because of the side effects, such as skin photosensitivity and compromised bladder function. To reduce the side effects they had to reduce the dosage which also reduced the efficacy.
It's taken 30 years, but finally with TLD1433, bladder instillation, green light, and more refined dosimetry, a better photodynamic treatment for BCG unresponsive NMIBC has been developed with a much better chance of wide adoption.