Theralase(R) Optimizes Phase II Bladder Cancer Clinical Study

Post Study II Monitoring of Response, Optional Maintenance Study II Treatments and Central Pathology Laboratory Review Optimized

TORONTO, ON / ACCESSWIRE / October 23, 2023 / Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV:TLT)(OTCQB:TLTFF), 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, announced that it has been granted a Clinical Trial Application Amendment ("CTA-A") by Health Canada through receipt of a No Objection Letter ("NOL") for the optimization of the Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") clinical study ("Study II").

The Study II optimization consists of:

1. Post Study II Monitoring of Response - Patients, who achieved a Complete Response ("CR") or Indeterminate Response ("IR"), demonstrated a duration of that response at 450 days and remained in Study II will be monitored by the Company past 450 days, to help define the long-term duration of the Study II Treatment.
2. Optional Maintenance Study II Treatment -Patients currently receive a mandatory maintenance Study II Treatment at 180 days; however, this has been optimized to allow optional maintenance Study II Treatments, at the discretion of the Principal Investigator ("PI") based on the patient's response. For patients who have achieved a CR or IR at any point in time and have demonstrated a duration of that CR or IR, no further maintenance Study II Treatments would be administered; however, if the patient recurs at any scheduled assessment visit (i.e.: 90, 180, 270, 360 or 450 days), then that patient would be eligible to receive up to 2 maintenance Study II Treatments at the discretion of the PI to assist the patient in achieving a CR.
3. Central Pathology Laboratory Review - Use of a central pathology laboratory to validate local pathology laboratory results.

Note: CR is defined as:

• Negative cystoscopy and negative (including atypical) urine cytology
• Positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative cytology
• Negative cystoscopy with malignant urine cytology, if urothelial cancer is suspected in the upper tract or prostatic urethra and random bladder biopsies are negative

Note: IR is defined as:

• Negative cystoscopy and positive urine cytology, without confirmatory negative bladder cancer biopsies

Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer of Theralase stated, "Based on our latest published clinical results in Study II, we are quickly approaching a critical stage in our NMIBC clinical development and commercialization program. There remains an unmet need in providing an adequate treatment option for thousands of Bacillus Calmette-Guérin ("BCG")-Unresponsive NMIBC patients, who are facing radical cystectomy. With Health Canada's CTA-A NOL approval letter, we are a significant step closer to providing these patients around the world with a much-needed breakthrough therapy to help treat their deadly disease. The recent press release of the Study II interim clinical data analysis provides support that Ruvidar^TM based Anti-Cancer Therapy ("ACT") may present a safe and effective treatment option for this patient population. Theralase looks forward to sharing additional safety and efficacy clinical data generated from Theralase's Study II next month."