Ruvidar (TLD-1433) / Theralase - LARVOL DELTA

A phase II clinical study of intravesical photo dynamic therapy in patients with BCG-unresponsive NMIBC (interim analysis). (ASCO-GU 2023) - P2 | " Out of a planned 125 patients, 42 patients have been enrolled and treated with two Study Treatments (Day 0 and Day 180) consisting of an intravesical instillation of the photosensitizer TLD-1433 (0.70 mg/cm2) followed by activation with a 520 nm intravesical laser under general anesthesia (Study Device TLC-3200) to a total of 90 J/cm2 of laser light... The interim data support that treatment with Photo Dynamic Therapy provides a viable treatment option for patients with BCG unresponsive CIS (+/- papillary disease) with an acceptable ongoing safety profile. Clinical trial information: NCT03945162. >"

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Urothelial Cancer

Interim Analysis of Light-Activated TLD-1433 in a Phase II Clinical Study of BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In-Situ (AUA 2026) - "The interim results support light-activated Ruvidar® as a viable treatment option for patients with BCG-Unresponsive NMIBC CIS (+/- papillary disease) with an acceptable safety profile."

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Photobiological applications of light-activated metallodrugs (ACS-Fall 2026) - P2 | "Clinically approved PSs are typically organic tetrapyrroles (e.g.: Photofrin, the only FDA-approved PS for cancer therapy), which mediate their effects primarily through singlet oxygen (1O2) and other reactive oxygen species (ROS)...One such compound, TLD1433 (Ruvidar®), a Ru(II) oligothienyl polypyridyl complex designed and synthesized in our laboratory, is currently in Phase 2 clinical trials (ClinicalTrials.gov identifier: NCT03945162) for photodynamic treatment of non-muscle invasive bladder cancer (NMIBC)...These complexes expand the design space for metal-based PDT agents, offering tunable photophysical properties and potentially distinct modes of biological action. Beyond their therapeutic applications, these complexes provide a unique opportunity to probe fundamental photochemical and photobiological processes—offering insight into alternative modes of cellular damage and energy transfer that may be harnessed in other light-driven biomedical or..."

Bladder Cancer • Genito-urinary Cancer • Solid Tumor

Interim Analysis of Light-Activated TLD-1433 in a Phase II Clinical Study of BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In-Situ (AUA 2025) - "The interim data support Light-Activated TLD-1433 photodynamic therapy as a viable treatment option for patients with BCG-Unresponsive NMIBC CIS (+/- papillary disease) with an acceptable safety profile."

Clinical • P2 data • Anesthesia • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Design and evaluation of photoactive metallodrugs for cancer therapy (ACS-Fall 2026) - "In this work, we describe the design, synthesis, and characterization of new metal-based complexes structurally analogous to TLD1433 that display potent phototoxicity upon light irradiation. Systematic modification of these complexes enables fine-tuning of their photophysical and photobiological properties, offering insights into the structure–activity relationships governing photoactivated cancer therapeutics."

Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Oxygen-Dependent Light-Induced Lipid Membrane Perturbation by TLD1433 as a Potential Contributor to Phototoxicity. (PubMed, Inorg Chem) - "Taken together, these results suggest that light-induced lipid membrane perturbation, including poration, may represent a contributing factor to the phototoxic effects of TLD1433 under normoxic conditions. This combined computational and experimental study details how the photochemical properties of TLD1433 influence membrane response in a light- and oxygen-dependent manner, offering a framework for understanding how such effects may contribute to PDT efficacy at an unprecedented molecular level."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

DNA-Targeted Sonodynamic Activation Enhances Antibacterial Efficacy in Deep and Hypoxic Infections. (PubMed, J Am Chem Soc) - "As a result, ultrasound-activated TLD1433 shows potent antibacterial efficacy in a murine Pseudomonas aeruginosa pneumonia model and in patient-derived bronchoalveolar lavage fluid under deep-tissue conditions. This work establishes a mechanistically distinct antibacterial sonodynamic strategy based on a clinically advanced ruthenium complex, providing a design framework for target-specific sonosensitizers against deep and hypoxic bacterial infections."

Journal • Infectious Disease • Pneumonia • Respiratory Diseases

Recent Advances in the Use of Osmium Complexes as Anticancer Phototherapeutics. (PubMed, Acc Chem Res) - "ConspectusSince the approval of cisplatin in the late 1960s, metal-based chemotherapies have garnered a continuous amount of attention...Sadler's osmium-arene complexes and McFarland's Os-4T compound, a structural analogue of the Ru-based TLD-1433 currently in clinical trial, demonstrated effective photoactivation and cytotoxicity, even under hypoxic conditions.Furthermore, osmium complexes can be chemically tuned to target organelles such as mitochondria and lysosomes or to selectively bind tumor markers such as carbonic anhydrases...Our laboratories have contributed several leading studies in this space, including structure-activity studies, ICD assays, and mechanistic exploration. Given the absence of a focused review in this area and the clinical momentum around both PDT/PACT and immunotherapy, the time is ideal for a concise and authoritative Account."

IO biomarker • Journal • Oncology

TLD-1433 Exhibits Early Efficacy in BCG-Unresponsive NMIBC CIS (Cancer Network) - "Specifically, among 87 patients treated with TLD-1433 who were evaluable for efficacy, the complete response (CR) rate was 64.4% (n = 56; 95% CI, 48.6%-80.2%), with a total response rate of 73.6% (n = 64; 95% CI, 56.7%-90.5%)....Moreover, among 47 evaluable responders, 40.4% (n = 19; 95% CI, 23.8%-57.1%) experienced a sustained CR at 450 days and 42.6% (n = 20; 95% CI, 26.6%-58.5%) experienced a sustained total response."

P2 data • Bladder Cancer

In Study II NCT03945162, Theralase is clinically investigating light-activated Ruvidar in the treatment of patients diagnosed with BCG-unresponsive NMIBC CIS (Study II). (Newsfile) - "Theralase has enrolled and successfully treated 88 out of a planned 90 patients in Study II and plans to complete enrollment and treatment of the remaining 2 patients by 1Q2026 with follow-up completed by 2Q2027."

Trial status • Bladder Cancer

Ferring Pharmaceuticals and Theralase(R) Technologies Announce Clinical Development Agreement to Investigate Combination Therapy in Bladder Cancer (Newsfile) - "The collaborative clinical study will evaluate ADSTILADRIN (nadofaragene firadenovec-vncg) in combination with the investigational drug Ruvidar (TLD-1433) in patients with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer carcinoma in-situ with or without papillary disease (±Ta/T1)...The new cohort of patients will explore the potential benefit of combining two innovative and complementary mechanisms of action...In the Collaborative Clinical Study, Theralase will apply to the FDA to add a new cohort to Study II. This cohort will be treated with Theralase's lead small molecule, light-activated Ruvidar, followed by treatment with Ferring's FDA-approved ADSTILADRIN."

Licensing / partnership • Trial status • Bladder Cancer

Interim Analysis of Light-Activated TLD-1433 in a Phase II Clinical Study of BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In-Situ (EAU 2026) - No abstract available

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Theralase® Technologies Inc. | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Jun 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Ruvidar®-An Effective Anti-Herpes Simplex Virus Agent. (PubMed, Viruses) - "Currently, effective FDA approved anti-herpetic drugs include acyclovir and later-generation derivatives (valacyclovir and famciclovir), which inhibit viral DNA synthesis...In these experiments, we evaluated the ability of Ruvidar® to restrict HSV-1 replication in Vero cells, both by itself and in combination with acyclovir and metformin in the absence of light activation to mimic deep tissue...We also discovered additive and synergistic anti-HSV-1 effects when combinational therapy was tested. Ruvidar® also restricted HSV-1 replication in human U251 glioblastoma astrocytoma cells, remained highly effective against acyclovir-resistant HSV-1 mutants, and protected infected cells from virus-induced cytopathology."

Journal • Astrocytoma • Brain Cancer • Glioblastoma • Herpes Simplex • Oncology • Solid Tumor

Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients (clinicaltrials.gov) - P2 | N=125 | Recruiting | Sponsor: Theralase® Technologies Inc. | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Optimizing the phototherapy effects of metallodrug photosensitizers for cancer treatment (ACS-Fall 2025) - P2 | "One of our PSs, TLD1433, is currently in Phase 2 clinical trials (NCT03945162) for treating bladder cancer with PDT. We will also focus on optimization of the PDT effect with the lead PSs by examining photocytotoxicity, cellular uptake, localization, and possibly induced anti-tumor immunity with modification of various light parameters in cancer treatment."

Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Applications of photoactivated metallodrugs for cancer therapy (ACS-Fall 2025) - P2 | "Our own TLD1433, a Ru(II) polypyridyl complex incorporating an oligothienyl-containing ligand, is one example and is currently in Phase 2 clinical trials (NCT03945162) for treating non-muscle invasive bladder cancer (NMIBC) with PDT. Herein, we report a novel class of metal-based PSs that are structurally similar to TLD1433 and highlight their light-driven PDT effects."

Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Theralase Provides Corporate Update | TLTFF Stock News (Gurufocus) - P2 | N=125 | NCT03945162 | Sponsor: Theralase Technologies Inc. | "The company reported a 91% enrollment completion with 82 out of 90 patients enrolled. Interim results have been promising, demonstrating a 62.3% Complete Response (CR) rate, and 41.9% of patients maintaining the response at 15 months. The company plans to submit a New Drug Application to Health Canada and the FDA by the fourth quarter of 2026, with the expectation of receiving a decision on marketing approval by the first quarter of 2027....In addition to its bladder cancer treatment, Theralase is advancing research in several other therapeutic areas. These include Glioblastoma Multiforme (GBM), Non-Small Cell Lung Cancer (NSCLC), Muscle Invasive Bladder Cancer (MIBC), various blood cancers, and HSV-1 (cold sores). The company plans to initiate Phase I/II studies in these areas by 2026."

Canada approval • Canada filing • Enrollment status • New P1/2 trial • P2 data • Bladder Cancer • Glioblastoma • Hematological Malignancies • Non Small Cell Lung Cancer

Predicting head and neck tumor nodule responses to TLD1433 photodynamic therapy using the image-guided surgery probe ABY-029. (PubMed, Photochem Photobiol) - "The findings warrant further studies using head and neck cancer nodules with heterogenous PDT responses and EGFR expression levels. If successful, the future goal would be to use ABY-029 to guide the dosimetry of intraoperative PDT of the surgical bed after IGS to eliminate all microscopic diseases, reduce recurrence rates, and prolong survival."

Journal • Bladder Cancer • Genito-urinary Cancer • Head and Neck Cancer • Oncology • Solid Tumor • EGFR

Image-based treatment planning for TLD1433 mediated intraoperative photodynamic therapy with an optical surface applicator-A translational rodent study. (PubMed, Photochem Photobiol) - "A TLD1433-mediated intraoperative PDT procedure using an instilled dose of 14 mg/kg and 532-nm laser light induces tumor cell degradation in the peritoneal cavity of rats. Our results suggest that the Monte Carlo simulation can be used as an image-based treatment plan for administering a controlled PDT procedure with OSA and TLD1433."

Journal • Preclinical • Lung Cancer • Oncology • Solid Tumor

Theralase Clinical Data Presented at Canadian Bladder Cancer Forum and American Urological Association (Newsfile) - P2 | N=125 | NCT03945162 | Sponsor: Theralase Technologies Inc. | "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...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)...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)....For the tertiary endpoint, 100% (64/64) of patients experienced no Serious Adverse Events ('SAEs') directly related to the Study Drug or Study Device."

P2 data • Bladder Cancer

LIGHT-ACTIVATED TLD-1433 IN A PHASE II CLINICAL STUDY OF BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER CARCINOMA IN-SITU (AUA 2025) - P2 | "Pathology will be validated by central review.To date 75 patients have received at least 1 study treatment. The trial accrual goal is 125 patients."

Clinical • P2 data • Anesthesia • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Ruvidar Demonstrates 7 Year Complete Response (Yahoo Finance) - "Theralase Technologies Inc...is pleased to announce that a patient enrolled in the Phase Ib Non-Muscle Invasive Bladder Cancer ('NMIBC') clinical study (A Phase 1b Clinical Study of Intravesical Photodynamic Therapy in Patients with Bacillus Calmette-Guérin-unresponsive Non-muscle-invasive Bladder Cancer - ScienceDirect) has demonstrated a sustained Complete Response ('CR') (negative cystoscopy and negative urine cytology) lasting over 7 years. The patient was diagnosed with Bacillus Calmette-Guérin ("BCG")-Unresponsive NMIBC Carcinoma In-Situ ('CIS') and was treated once with the therapeutic dose of Theralase's lead small molecule Ruvidar, which was subsequently activated with the TLC-3200 medical laser system."

P1 data • Bladder Cancer

Theralase Interim Clinical Data to be Presented at the 2025 AUA Annual Meeting (ACCESSWIRE) - "The Program Committee of the AUA has accepted the Theralase's abstract titled: 'Interim Analysis of Light-Activated TLD-1433 in a Phase II Clinical Study of BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In-Situ' for presentation in a Podium Session at the 2025 Annual Meeting of the American Urological Association to be held in Las Vegas, Nevada, April 26th to 29th....The interim clinical data supports the high safety and efficacy of the treatment with a number of patients demonstrating a duration of response of 3 years or greater with a single treatment."

P2 data • Bladder Cancer

Theralase Launches New Clinical Study Site in Canada (ACCESSWIRE) - "Theralase Technologies Inc...is pleased to announce that it has launched a new Clinical Study Site ('CSS') for its bladder cancer clinical study; specifically, St. Joseph's Healthcare Hamilton (Hamilton, Ontario, Canada). Theralase's lead drug, Ruvidar (TLD-1433), activated by the TLC-3200 Medical Laser System ('TLC-3200') is currently under clinical investigation in Canada and the United States in a Phase II registration study for Bacillus Calmette-Guérin ('BCG')-Unresponsive Non-Muscle Invasive Bladder Cancer ('NMIBC') Carcinoma In-Situ ('CIS') with or without resected Ta / T1 papillary disease ('Study II'). An estimated 83,190 patients in the United States1 and 12,300 patients in Canada2 will be diagnosed with bladder cancer in 2024....The total clinical study sites enrolling patients in North America is now 11 (6 in Canada, 5 in US) with an additional 4 clinical study sites (1 in Canada, 3 in US) scheduled to launch in 4Q2024/1Q2025."

Trial status • Bladder Cancer