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Re: None

Tuesday, 06/13/2017 7:55:01 PM

Tuesday, June 13, 2017 7:55:01 PM

Post# of 4159
Conclusions of the presentation included:

TLD-1433 has good selectivity compared to other PSs
Intravesical instillation is adequate to deliver TLD-1433 to NMIBC
Laser light of 525 to 532 nm in wavelength provides effective activation of the PDC up to 2 to 3 mm, more than sufficient for NMIBC
Irradiance across the bladder surface is heterogenous
TLD-1433 NMIBC PDT produces non-clinically significant AEs.
Longer term observations will determine the efficacy of the PDT treatment
Roger Dumoulin-White, President and CEO of Theralase stated that, “Theralase is delighted that the latest dosimetry planning and Phase Ib clinical study results were presented to such a respected group of international researchers and clinicians at the 16th IPA World Congress. This research will ultimately allow Theralase to successfully commercialize this next generation PDT technology, after efficacy has been proven, now that safety, tolerability and PK have been established.”

Based on these clinical findings, the independent Data and Safety Monitoring Board (“DSMB”) has unanimously decided that the primary and secondary objectives for the first part of the Study have successfully been met and an additional 6 patients are now eligible to be enrolled into the Study to be treated at a therapeutic dose of the PDC (0.70 mg/cm2) and monitored for 180 days, according to the endpoint criteria.