Theralase Technologies Inc (TLTFF)

[The Rainmaker]

TLTFF fast trial results 30 days for first results.

The primary outcome measures of a Phase Ib NMIBC clinical study will be safety and tolerability, with a secondary outcome measure of pharmacokinetics (where the drug accumulates in tissue and how it exits the body) and an exploratory outcome measure of efficacy.

The Phase Ib NMIBC clinical study protocol will commence by instilling a low dose of TLD-1433 drug into the bladders of three (3) patients with subsequent light activation using the TLC-3200 / TLC-3400 medical laser technology. These three (3) patients will then be monitored for thirty (30) days to ensure safety and tolerability of the procedure. If no adverse events are reported, then an additional six (6) patients will be enrolled at a high dose, followed by light activation and follow-up monitoring for six (6) months.

If safety and tolerability of the procedure is demonstrated in these nine (9) patients, the Phase Ib study results will support Health Canada approval and a Phase II multi-center efficacy study for NMIBC will be commenced in Canada, the United States and Europe.

Mr. Dumoulin-White concluded that, “The Company looks forward to commencing a Phase Ib clinical study for NMIBC in 4Q2016