On May 20, 2025 Theralase Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their formulations, intended for the safe and effective destruction of various cancers, bacteria and viruses, reported a corporate update outlining the Company’s strategic objectives (Press release, Theralase, MAY 20, 2025, View Source [SID1234653881]).
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1) Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") Registrational Clinical Study ("Study II")
Theralase has made steady progress on the completion of Study II by enrolling and providing the primary study procedure for 82 patients out of a target of 90 patients (91% enrollment).
According to the clinical study design, a patient is considered to have completed Study II, if they receive the study procedure (study drug activated by study device) and have been assessed by the Principal Investigator ("PI") for up to 15 months or they have been prematurely removed from the clinical study by the PI for failure to respond or failure to comply with the clinical study design.
According to this definition, 69 patients have completed Study II (with 13 patients on study with pending clinical data) resulting in the following interim clinical data in support of the Study II endpoints.
Primary Endpoint Performance (CR at any Point in Time)
# % Confidence Interval (95%)
Complete Response ("CR") 43/69 62.3% [43.7, 80.9]
Total Response (CR and IR) 48/69 69.6% [49.9, 89.2]
Secondary Endpoint Performance (Duration of CR) (15 months)
# % Confidence Interval (95%)
Complete Response ("CR") 18/43 41.9% [22.5, 61.2]
Tertiary Endpoint Performance (Safety) (15 months)
# %
Safety 69/69 100.0%
For 82 patients treated in Study II, there have been no Serious Adverse Events ("SAEs") directly related to the Study Drug or Study Device.
Outside of the defined endpoints of Study II, Theralase has demonstrated a duration of CR at extended time points, as follows:
Duration of CR
Time # % Confidence Interval (95%)
2 Years 10/43 23.3% [8.8, 37.7]
3 Years 9/43 20.9% [7.3, 34.6]
7 Years 1/43 2.3% [0.0, 6.9]
Note: Not all patients have been assessed at these extended time points. As more clinical data is collected, the duration of CR at 2 and 3 years may increase.
If approved by the regulatory authorities, the interim clinical data obtained could significantly benefit patients who are faced with a radical cystectomy (removal of their bladder), as the Theralase treatment provides a strong initial CR and an equally strong duration of that CR over time. It is made even more impressive by the fact that this clinical data was achieved with only one study procedure in the majority of cases.
Theralase is on track to complete enrollment in Study II by the summer of 2025.
This will allow the Company to report on 75 patients who have completed Study II in December 2025 and to report on all 90 patients by September 2026.
Upon follow-up of all patients, the Company plans to submit a New Drug Application ("NDA") to Health Canada and the FDA in 4Q2026, with a decision expected by the respective regulatory authorities on a marketing approval by 1Q2027.
As Theralase completes enrollment in Study II, it is actively searching for commercialization partners for international marketing and sales of Ruvidar.
To this end, Theralase is in various stages of initial and advanced discussions with international pharmaceutical companies for various geographical territories concerning:
Licensing of the light-activated Ruvidar for BCG-Unresponsive NMIBC CIS
Collaborative research focused on investigating light-activated Ruvidar in the treatment of NMIBC
Collaborative research focused on combining Ruvidar with other FDA approved drugs
In recent discussions with the FDA, the Company has decided that since Study II is 91% complete, that the best course of action is not to pursue Break Through Designation, but to complete Study II and submit the clinical data to the FDA in a formal NDA. At the end of the meeting, the FDA made a comment that they were impressed that the interim clinical data obtained to date was able to be achieved with only one clinical treatment, in the majority of cases.
Ruvidar has demonstrated 10 years shelf life, strongly supporting the stability of the molecule and the ability of clinics to store the small molecule for extended periods of time.
2) Glio Blastoma Multiforme ("GBM") Brain Cancer Treatment
Theralase has successfully completed pre-clinical research to develop Ruvidar for the destruction of GBM. The Company expects to complete Good Laboratory Practice ("GLP") toxicology in 4Q2025 to allow commencement of a Phase I/II adaptive clinical study in 1Q2026.
3) Non-Small Cell Lung Cancer ("NSCLC") Treatment
Theralase has finished conducting pre-clinical research to develop Ruvidar for the destruction of NSCLC. Mice treated with x-ray activated Rutherrin in a Lewis Lung Cancer ("LLC1") orthotopic model have demonstrated up to a 4-fold slower tumour progression, based on the Magnetic Resonance Imaging assessment of tumour volumes.
4) Muscle Invasive Bladder Cancer ("MIBC") Treatment
Theralase is conducting pre-clinical research to develop Ruvidar for the destruction of MIBC as an intravenous treatment for patients that are inflicted with this disease. The Company expects to complete GLP toxicology in 4Q2025 to allow commencement of a Phase I/II adaptive clinical study in 1Q2026.
5) Leukemia, Lymphoma and Myeloma Treatment
Theralase is conducting pre-clinical research to develop Ruvidar for the destruction of Leukemia, Lymphoma and Myeloma as an extracorporeal treatment for patients that are inflicted with these diseases. Theralase plans to develop this technology in 2026.
6) Herpes Simplex Virus ("HSV-1") Topical Treatment for Cold Sore Lesions
Theralase is conducting pre-clinical research to develop Ruvidar for the inactivation of HSV-1 as a topical treatment for the billions of patients worldwide that are inflicted with cold sores on an annual basis. The Company is using its internal research laboratory to develop the topical formulation to be used in preclinical and clinical evaluation.
The Company expects to complete GLP toxicology in 4Q2025 to allow commencement of a Phase I/II adaptive clinical study in 1Q2026.
The research, which demonstrated that RuvidarTM was effective at inactivating both enveloped and non-enveloped viruses, alone and when light activated was accepted in a peer-reviewed publication, Heliyon, and can be reviewed at View Source
7) Cross Listing to a US Exchange
The Company has raised $CAN 6.3 million over the last 2 years in support of it research and development programs. It is currently investigating the use of a full-service investment bank in the United States to advise on potential financings and US listing opportunities. Information on any future financings will be released once available in accordance with applicable securities laws.
2025/2026: Potentially Transformative Years
Theralase is positioning itself to deliver on a series of significant clinical and corporate milestones in 2025; including:
Completing Study II and submitting an NDA to Health Canada and the FDA
Commencing Phase I/II adaptive clinical studies in: GBM, NSCLC, MIBC, HSV and Leukemia
Evaluating strategic financing and listing opportunities in the US market
These efforts should collectively support long-term shareholder value and reinforce Theralase’s leadership in light / radiation-activated drug therapy for the destruction of various cancers and viruses.
About Study II:
Study II utilizes the therapeutic dose of the patented study drug (Ruvidar) (0.70 mg/cm2) activated by the proprietary study device (TLC-3200 Medical Laser System). Study II is focused on enrolling and treating approximately 90 BCG-Unresponsive NMIBC CIS patients in 12 clinical study sites located in Canada and the United States.
About Ruvidar:
Ruvidar(TLD-1433) is a small molecule, 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.