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Theralase Provides Update on Phase II Bladder Cancer Study
For the primary objective, 65% of Evaluable Patients (Patients evaluated by a Principal Investiga...
About this update from Theralase Technologies Inc.
[{"type":"text","content":"Theralase Provides Update on Phase II Bladder Cancer StudyFor the primary objective, 65% of Evaluable Patients (Patients evaluated by a Principal Investigator (\"PI\")) achieved a Complete Response (\"CR\") at any assessment date post primary Study Treatment and 30% of Evaluable Patients achieved a CR at 450 days.TORONTO, ON / ACCESSWIRE / May 10, 2023 / Theralase® Technologies Inc. (\"Theralase®\" or the \"Company\") (TSXV:TLT) (OTCQB:TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds (\" PDCs\") and their associated drug formulations, used to safely and effectively destroy various cancers, bacteria and viruses, announced today an update on its recently reported Phase II clinical study (\"Study II\") interim clinical data.Background:Study II was designed to treat patients diagnosed with Bacillus Calmette-Guérin (\"BCG\")-Unresponsive, Non-Muscle Invasive Bladder Cancer (\"NMIBC\") Carcinoma In-Situ (\"CIS\") (with or without resected papillary Ta/T1 disease) with a patented investigational study drug Ruvidar™ (TLD-1433 - a ruthenium based PDC intravesically instilled into a patient's bladder), subsequently activated by a proprietary investigational study device (TLC-3200 Medical Laser System - a green (520 nm) laser system equipped with fiber-optic light emitters and detectors).In recent discussions with the Medical and Scientific Advisory Board (\"MSAB\") for Study II, the MSAB advised the Company to review the FDA Guidance to Industry1 on how to best classify Indeterminate Response (\"IR\") patients (patients assessed with negative cystoscopy and positive urine cytology), where the source of the positive urine cytology has not been determined.The FDA Guidance to Industry1 states as follow:\"For single-arm trials of patients with BCG-unresponsive disease, the FDA defines a complete response as at least one of the following:Negative cystoscopy and negative (including atypical) urine cytologyPositive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative cytologyFor intravesical therapies without systemic toxicity, the FDA includes, in the definition of a complete response, negative cystoscopy with malignant urine cytology if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are ne...