Sound Very Optimistic to me ! 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.”