Theralase Technologies Inc. V.TLT

Optimizes Phase II Bladder Cancer Clinical Study

[knoxt]

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