TORONTO, Canada – Theralase Technologies Inc., a clinical stage pharmaceutical company dedicated to the research and development of light and/or radiation activated Photo Dynamic Compounds (” PDCs “) for the safe and effective destruction of various cancers, bacteria and viruses is providing an update regarding its Phase II Non-Muscle Invasive Bladder Cancer (” NMIBC “) clinical study (” Study II “).
To date, Study II has provided the primary study treatment for 63 patients.
In 2016, Kamat et al. stated in the Journal of Clinical Oncology that the International Bladder Cancer Group (” IBCG “) recommended that, “ Single-arm designs may be relevant for the BCG-unresponsive population. Here, a clinically meaningful initial complete response rate (for carcinoma in situ) or recurrence-free rate (for papillary tumors) of at least 50% at 6 months, 30% at 12 months and 25% at 18 months is recommended. “
The Study II interim clinical data demonstrates a Complete Response (” CR “) of 54% at 6 months, 38% at 12 months and 37% at 15 months, which exceeds the IBCG guidelines.
In addition, the Study II interim clinical data demonstrates that at the 90 Day Assessment Visit, 56% of Evaluable Patients achieved a CR and 63% achieved a Total Response (CR + IR), while at 450 days, 37% achieved a CR and 41% achieved a TR.
The interim clinical data for patients who received the optimized Study II Treatment demonstrates that at the 90 Day Assessment Visit, 62% of Evaluable Patients achieved a CR and 68% achieved a Total Response (CR + IR), while at 450 days, 39% achieved a CR and 44% achieved a TR.
In 2020, the FDA granted Theralase® Fast Track Designation (” FTD “) for Study II. As a Fast Track designee, Theralase® has access to early and frequent communications with the FDA to discuss Theralase®’s development plans and ensure the timely collection of clinical data to support the approval process. The accelerated communication with the FDA potentially allows, the Study II Treatment, to be the first intravesical, patient-specific, light-activated, Ruthenium-based PDC for the treatment of patients diagnosed with BCG-Unresponsive NMIBC CIS, (with or without recurrent / resected papillary T a /T 1 tumours). FTD can lead to Break Through Designation (” BTD “), Accelerated Approval (” AA “) and/or Priority Review, if certain criteria are met.
In mid-2023, the Company submitted a pre-BTD submission to the FDA and based on the FDA’s feedback, the Company is currently working with the Clinical Study Sites (” CSSs “), a central pathology organization, a biostatistics organization and a regulatory consulting organization to update the pre-BTD with clinical data clarifications identified by the FDA. The Company plans to resubmit the pre-BTD submission to the FDA in 1Q2024 for FDA review of these clarifications. Once the pre-BTD submission has been accepted by the FDA, the Company plans to compile a BTD submission for review by the FDA in support of the grant of a BTD approval.
Theralase® is working to complete enrollment and delivery of the primary Study II Treatment for all patients in 2024. If successful, this would allow clinical data lock in mid-2026 with a potential Health Canada and FDA approval by 2026 / 2027.
About Study II
Study II utilizes the therapeutic dose of the patented Study II Drug (“Ruvidar TM” or ” TLD-1433 “) (0.70 mg/cm 2 ) activated by the proprietary Study II Device (” TLC-3200 Medical Laser System “). Study II is focused on enrolling and treating approximately 100 BCG-Unresponsive NMIBC Carcinoma In-Situ (” CIS “) patients in up to 15 CSSs located in Canada and the United States.
About Ruvidar TM
Ruvidar TM is a patented PDC with 12 years of published peer reviewed preclinical research and is currently under investigation in Study II.
About Theralase® Technologies Inc.
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated compounds, their associated drug formulations and the light systems that activate them, with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses.
Contact
Kristina Hachey, CPA
Chief Financial Officer
[email protected]