08:35 AM EDT, 04/05/2022 (MT Newswires) -- Theralase Technologies (TLT.V), a clinical-stage pharmaceutical company, on Tuesday provided an update on the Phase II Non-Muscle Invasive Bladder Cancer (NMIBC) Clinical Study (Study II).
Theralase successfully completed a Phase Ib NMIBC Clinical Study (Study I), which enrolled and provided the primary study treatment, at the therapeutic dose, for three patients. To date, Study II has enrolled and provided the primary study treatment for 35 patients, which when combined with the Study I data, leads to a total of 38 patients, who have received at a minimum, the primary study treatment.
Study II has delivered significant clinical results to date for the primary, secondary and tertiary objectives, Theralase said:
From the 38 patients treated to date in Study II, those evaluable patients, have achieved 50.0% CR (complete response) at 90 days and 25.0% have maintained this CR for at least 450 days, since primary study treatment. Additionally, total responders (CR +Partial Response, PR) at 90 days is 60.5% and 18.4% at 450 days. There is significant data still pending.
Theralase also noted that only seven serious adverse events (SAEs) were reported to date, and the company believes these are unrelated to the study drug or study device.
"In conclusion, it is encouraging to see, from the preliminary clinical data that the company has accumulated to date, that if the trends continue, then Theralase is on track to achieving the primary, secondary and tertiary Study II objectives," Dr. Vera Madzarevic, Director of Clinical Development and Quality Assurance, said.