On May 5, 2025 Theralase Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of small molecules and their formulations, able to be activated by light, radiation, sound and/or other drugs, intended for the safe and effective destruction of various cancers, bacteria and viruses, reported that its latest interim clinical data was recently presented at the Canadian Bladder Cancer Forum 2025 and the American Urological Association 2025 Annual Meeting (Press release, Theralase, MAY 5, 2025, View Source [SID1234653900]).
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The interim clinical data from Theralase’s multicenter Phase II Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") study ("Study II") was presented by Dr. Girish Kulkarni in podium presentations. Dr. Kulkarni, M.D., Ph.D., FRCSC is a urologic surgeon in the Department of Surgical Oncology, Princess Margaret Cancer Centre, University Health Network, a professor in the Department of Surgery at the University of Toronto and the lead principal investigator in the Theralase study.
The interim clinical data presented represents world-class safety and efficacy in the treatment of BCG-Unresponsive NMIBC CIS with a light-activated small molecule. Numerous patients have demonstrated durations of response of 3 years or greater, with 1 patient demonstrating a duration of response of over 7 years, after a single treatment.
Study II Interim Clinical Data1:
Theralase has enrolled and treated 79 patients in Study II, who have been provided the primary Study Procedure (therapeutic dose of Theralase’s lead small molecule RuvidarTM light-activated by the TLC-3200 medical laser system), with completion of enrollment expected by mid-2025.
81% (64/79) of treated patients have completed the clinical study or have been prematurely removed by the PI according to the clinical study protocol are used in the efficacy analysis below.
Performance to Primary Objective:
For the primary endpoint, 62.5% (40/64) of patients treated demonstrated a Complete Response ("CR") (negative cystoscopy and negative urine cytology) at any point in time).
Including patients, who demonstrated an Indeterminate Response ("IR") (negative cystoscopy and positive or suspicious urine cytology), the Total Response increases to 68.8% (44/64).
Primary Endpoint Performance (CR at any Point in Time)
# % Confidence Interval (95%)
Complete Response ("CR") 40 62.5% [43.1, 81.9]
Total Response (CR and IR) 44 68.8% [48.5, 89.1]
Performance to Secondary Objective:
For the secondary endpoint, 45.0% (18/40) of patients, who achieved a CR, maintained their CR response for at least 12 months (450 days from date of Study Procedure).
Secondary Endpoint Performance (Duration of CR) (450 Days)
# % Confidence Interval (95%)
Complete Response ("CR") 18 45.0% [24.2, 65.8]
Performance to Tertiary Objective:
For the tertiary endpoint, 100% (64/64) of patients experienced no Serious Adverse Events ("SAEs") directly related to the Study Drug or Study Device.
Tertiary Endpoint Performance (Safety) (450 Days)
# %
Safety 64 100.0%
25.0% (10/40) of patients who achieved a CR, continue to demonstrate a CR at 24 months from the date of the Study Procedure.
20.0% (8/40) of patients who achieved a CR continue to demonstrate a CR at 36 months from the date of the Study Procedure.
33% (1/3) of patients enrolled in the Phase Ib NMIBC clinical study2 treated once with the Study Procedure has demonstrated a sustained CR lasting over 7 years.
Serious Adverse Events
For 79 patients treated in Study II, there have been 15 Serious Adverse Events ("SAEs") reported:
1 – Grade 1 (resolved within 9 days)
3 – Grade 2 (resolved within 1, 1 and 33 days, respectively)
7 – Grade 3 (resolved within 1, 2, 3, 4, 4, 82 and unknown days, respectively)
3 – Grade 4 (resolved within 3, 6 and 8 days, respectively)
1 – Grade 5
Theralase believes all SAEs reported to date are unrelated to the Study II Drug or Study II Device.
Pending regulatory approval, this innovative technology represents a significant opportunity for an advancement in bladder cancer treatment, with only one treatment, by providing a safe and effective therapy for patients, who have exhausted their standard of care therapeutic options and are facing radical cystectomy (bladder removal).
Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer, Theralase stated, "I am delighted that the interim clinical data of Study II continues to demonstrate both high safety and high efficacy in the treatment of patients diagnosed with BCG-Unresponsive NMIBC CIS. Management of BCG-Unresponsive NMIBC CIS is and remains an unmet need and I look forward to the completion of enrollment in the clinical study this summer, which pending regulatory approval could provide an opportunity for patients to receive this treatment as part of routine clinical practice in both Canada and the United States. What we have learned in our research is that Theralase’s light-activated small molecule, Ruvidar, is able to destroy cancer through the production of reactive oxygen species and stimulation of the immune system by blocking multiple immune checkpoints, such as: CD474 (a dominant macrophage checkpoint signal on cancer cells that signals the immune system whether to destroy them or leave them alone), PD-L15 (a protein that acts as a "brake" on the immune system, preventing T cells from attacking cancer cells) and the recently discovered reduction of deubiquitinating enzymes6 (an important class of enzymes, which have been linked to numerous cancers and neurogenerative diseases)."
Roger DuMoulin-White, B.Sc., P.Eng., Pro.Dir., President and Chief Executive Officer, Theralase stated, "The presentation of the interim clinical data to the urological community at the major Canadian and American conferences provides the global urologist community and healthcare professionals, an opportunity to see firsthand the strong clinical data that the uro-oncologists involved in the clinical study have been able to deliver with the Theralase technology. RuvidarTM has proven to be a very versatile small molecule, with its ability to destroy cancer, bacteria and viruses, when activated by light, radiation, sound or even other drugs. Pending regulatory approval, the latest clinical data presented supports the use of light-activated Ruvidar by the urology community to safely and effectively treat patients inflicted with BCG-Unresponsive NMIBC CIS, helping to revolutionize the treatment landscape for bladder cancer. As Theralase wraps up the Phase II NMIBC clinical study in 2025 with a Health Canada and FDA regulatory submission planned in late 2026, I look forward to working with our world-class scientists, researchers and medical doctors in the commencement of numerous new clinical studies, focused on hard to treat viral infections, such as herpes simplex virus lesions (cold sores), through to some of the deadliest and most difficult to treat cancers in the world, such as: glioblastoma multiforme, non-small cell lung cancer, pancreatic cancer, leukemia, muscle invasive bladder cancer and colorectal cancer."
About Carcinoma In-Situ:
CIS of the bladder is an aggressive type of NMIBC characterized as a flat, high-grade tumour confined to the urothelial layer. NMIBC comprises approximately 75% to 80% of all bladder cancers, with CIS found in about 10% of cases.7
Management of CIS of the bladder remains a complex and challenging endeavor due to its high rate of recurrence and progression. Although it is typically grouped with other NMIBCs, its higher grade and aggressiveness make it a unique clinical entity. Intravesical BCG is the standard first-line treatment given its superiority to other agents; however, high rates of BCG failure highlight the need for additional therapies.8
CIS in the bladder is associated with a less favourable prognosis. It is more likely to recur after treatment. There is also a greater risk of CIS developing into Muscle Invasive Bladder Cancer ("MIBC").