Improvements on all fronts with the last 27 patients Performance to Objectives:
Primary:
For 38 patients enrolled and treated in Study II:
44.7% achieved CR at 90 days, with 50% achieving CR with evaluable patients and a potential of 71.1%, if all PR and Pending patients achieved CR
For 23 patients enrolled and treated in Study II (who received an optimized primary study treatment):
52.2% achieved CR at 90 days, with 60% achieving CR with evaluable patients and a potential of 82.6%, if all PR and Pending patients achieved CR
Secondary:
For 38 patients enrolled and treated in Study II:
13.2% achieved CR at 450 days, with 25% achieving CR with evaluable patients and a potential of 65.8%, if all PR and Pending patients achieved CR
For 27 patients enrolled and treated in Study II (who received an optimized primary or maintenance study treatment):
3.7% achieved CR at 450 days, with 11.1% achieving CR with evaluable patients and a potential of 74.1%, if all PR and Pending patients achieved CR
Tertiary:
For 38 patients enrolled and treated in Study II, there have been 7 Serious Adverse Events (“SAEs”) reported:
- 1 – Grade 2 (resolved within 1 day)
- 3 – Grade 3 (resolved within 5, 80 and 107 days, respectively)
- 2 – Grade 4 (resolved within 6 and 6 days, respectively)
- 1 – Grade 5 (not resolved))
Theralase® believes all SAEs reported to date are unrelated to the Study Drug or Study Device, subject to final review and confirmation by the independent Data Safety Monitoring Board (“DSMB”).
Conclusion:
Study II has delivered significant clinical results to date for the primary, secondary and tertiary objectives.
Dr. Vera Madzarevic, Ph.D., Director of Clinical Development and Quality Assurance at Theralase® stated, “From the 38 patients treated to date in Study II, those evaluable patients, have achieved 50.0% CR at 90 days and 25.0% have maintained this CR for at least 450 days, since primary study treatment. Additionally, total responders (CR +PR) at 90 days is 60.5% and 18.4% at 450 days; however, there is significant data still pending. This provides clinical support for achieving the primary and secondary objectives of Study II. The tertiary objective clinical data is promising, as only 7 SAEs were reported to date. Theralase® believes these 7 SAEs 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. Arkady Mandel M.D. Ph.D. D.Sc., Interim Chief Executive Officer and Chief Scientific Officer, Theralase® stated, “I am encouraged by the clinical results to date, which demonstrate the potential to fill an unmet need for patients diagnosed with BCG-Unresponsive NMIBC. These patients are facing bladder removal and by delivering them a complete response with a durability lasting up to 15 months post primary study treatment, Theralase® is providing them an opportunity to retain their bladder and the quality of life associated with it.”