PR: TLT Provides Update on Bladder Cancer Clinical Study TLD 1433-2 Clinical Study (Evaluable Patients) |
Assessment | 90 Day | 90 Day | 180 Day | 180 Day | 270 Day | 270 Day | 360 Day | 360 Day | 450 Day | 450 Day |
# | % | # | % | # | % | # | % | # | % |
Complete Response ("CR") | 33 | 58% | 31 | 56% | 23 | 46% | 16 | 36% | 14 | 33% |
Indeterminate Response ("IR") | 4 | 7% | 8 | 15% | 6 | 12% | 2 | 4% | 2 | 5% |
Total Responders (CR and IR) | 37 | 65% | 39 | 71% | 29 | 58% | 18 | 40% | 16 | 38% |
Total Evaluated | 57 | | 55 | | 50 | | 45 | | 42 | |
Mr. Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, President and Chief Executive Officer of Theralase® stated, "To date, the Theralase® Study II clinical data has demonstrated best-in-class performance for a single agent, providing high efficacy, durable response and a high safety profile, with no serious adverse events directly related to RuvidarTM or the TLC-3200 Medical Laser System. Theralase® hopes to complete patient enrollment with accompanying administration of the primary Study II Treatment by year end 2024. If successful, this will allow the Company the ability to complete assessment of the primary, secondary and tertiary endpoints of these patients by 2026. Based on the clinical data to date, Theralase® is investigating potential partnerships for commercialization, financing and distribution of this ACT technology on an international basis. Theralase® looks forward to commercializing this world-class technology for the benefit of all shareholders."
Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer of Theralase® stated, "Theralase® is delighted in its latest clinical data analysis. The Theralase® RuvidarTM-based Anti-Cancer Therapy ("ACT") has shown remarkable single-agent activity by proving to be safe and effective on a very difficult to treat BCG-Unresponsive patient population that has been diagnosed with high-grade NMIBC CIS, with or without resected Ta / T1 papillary tumours. These patients have failed the standard of care, such as BCG therapy and a large majority of them have failed treatment with various modern immunotherapy drugs. Theralase® has been able to demonstrate strong efficacy in the form of a CR or IR, with a well-tolerated safety profile, after predominately one treatment. This ACT technology, pending successful regulatory approval and commercialization, will be very attractive to patients, uro-oncologists and the insurance companies that insure these patients."