Theralase Technologies announces update on phase II bladder cancer clinical study

Theralase Technologies Inc, a clinical stage pharmaceutical company dedicated to the research and development of light and/or radiation activated Photo Dynamic Compounds (PDCs) for the safe and effective destruction of various cancers, bacteria and viruses is providing an update regarding its phase II non-muscle invasive bladder cancer (NMIBC) clinical study (study II). To date, study II has provided the primary study treatment for 63 patients.

In 2016, Kamat et al. stated in the Journal of Clinical Oncology that the International Bladder Cancer Group (IBCG) recommended that, "Single-arm designs may be relevant for the BCG-unresponsive population. Here, a clinically meaningful initial complete response rate (for carcinoma in situ) or recurrence-free rate (for papillary tumors) of at least 50 per cent at 6 months, 30 per cent at 12 months and 25 per cent at 18 months is recommended".

Based on the 63 patients treated to date, the interim clinical data for study II is presented. The study II interim clinical data demonstrated a complete response (CR) of 54% at 6 months, 38% at 12 months and 37% at 15 months, which exceeds the IBCG guidelines.

In addition, the study II interim clinical data demonstrated that at the 90 day assessment visit, 56% of evaluable patients achieved a CR and 63% achieved a total response (CR+IR), while at 450 days, 37% achieved a CR and 41% achieved a TR.

For evaluable patients in study II, who received the optimized study II treatment (post August 1, 2020), the interim clinical data is presented below: Assessment; Patient Assessment Visit (Optimized Treatment - Post August 1, 2020); Complete Response; Indeterminate Response (IR);

Total Response (CR and IR). The interim clinical data for patients who received the optimized study II treatment demonstrated that at the 90 day assessment visit, 62% of evaluable patients achieved a CR and 68% achieved a total response (CR + IR), while at 450 days, 39% achieved a CR and 44% achieved a TR.

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