Ruvidar (TLD-1433) / Theralase - LARVOL DELTA

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

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

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

Theralase(R) Release’s 3Q2024 Financial Statements (ACCESSWIRE) - "'In 2024 and 2025, the Company plans to secure funding through various equity and debt instruments to allow the Company the ability to become base shelf eligible. This will allow the Company sufficient funding to complete enrollment into Study II in 2025, data lock in mid 2026 and position the Company for FDA and Health Canada approval by the end of 2026, subject to achieving FDA Priority Review.'...Study II utilizes the therapeutic dose of the patented Study II Drug ('Ruvidar' or 'TLD-1433') (0.70 mg/cm 2 ) activated by the proprietary Study II Device...Study II is focused on enrolling and treating approximately 75 to 100 BCG-Unresponsive NMIBC Carcinoma In-Situ....patients in up to 15 Clinical Study Sites ('CSS') located in Canada and the United States."

Canada approval • FDA approval • Financing • Trial status • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Theralase(R) Release’s 3Q2024 Financial Statements (ACCESSWIRE) - P2 | N=125 | NCT03945162 | Sponsor: Theralase Technologies Inc. | "To date, Theralase has enrolled and treated 75 patients in Study II, who have been provided the primary Study Procedure by the CSSs...Theralase plans to add up to 5 new CSSs in 4Q2024/1Q2025, as well as increase enrollment at the existing 10 CSSs to complete Study II accruement in 2025...For the primary endpoint of Study II (CR at any point in time) 61.9% (39/63) [42.5, 81.3] of patients provided the Study Procedure (Study Drug activated by the Study Device) demonstrated a CR (negative cystoscopy and negative urine cytology; positive cystoscopy (low grade) and negative cytology or negative cystoscopy and suspicious / positive urine cytology with confirmed upper tract / prostatic urethra disease and negative bladder biopsies)...For the secondary endpoint of Study II (duration of CR) 43.6% (17/39) [22.9, 64.3] of treated patients who achieved a CR, maintained their CR response for at least 12 months..."

P2 data • Trial status • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

From Concept to Cure: The Road Ahead for Ruthenium-Based Anticancer Drugs. (PubMed, ChemMedChem) - "Among these, Ru complexes, exemplified by BOLD-100 and TLD1433, have shown exceptional promise due to their selective activity, lower propensity for resistance, and the ability to target spescific cellular pathways. This paper explores the journey of such Ru candidates, focusing on the mechanisms, efficacy, and clinical potential of these Ru-based drugs, which stand at the forefront of current research, aiming to provide more targeted, less toxic, and highly effective cancer treatments."

Journal • Review • Oncology

Theralase Technologies reports positive interim results from bladder cancer study (Proactiveinvestors) - P2 | N=125 | NCT03945162 | Sponsor: Theralase Technologies Inc. | "Theralase Technologies Inc...has provided an update on its ongoing bladder cancer clinical study involving Ruvidar, its light-activated drug, which is being investigated for Bacillus Calmette-Guérin (BCG)-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)....An interim analysis of the study data showed that the primary objective of the study, complete response (CR) at any point, was achieved by 60.3% of patients, exceeding the 50% benchmark set by international guidelines. For the secondary objective, 26.5% of patients maintained a CR at 450 days. The study also demonstrated promising long-term efficacy, with some patients sustaining CR for up to 1,080 days. The total response rate, which includes both complete and indeterminate responses, was 72.1%."

P2 data • Bladder Cancer

Theralase(R) Release’s 2Q2024 Financial Statements (ACCESSWIRE) - "Under the terms of the consulting agreement, Dr. Jewett will be responsible for working with existing clinical study sites and helping to onboard new clinical study sites to assist Theralase to complete enrollment and provide the primary study treatment to 75 to 100 patients in Study II, preferably by December 31, 2024. To date, Theralase has enrolled and treated 72 patients in Study II, who have been provided the primary Study II Procedure....Theralase plans to add up to 5 new CSSs in 2024, as well as increase enrollment at the existing 10 Clinical Study Sites ('CSSs') to complete Study II accruement by the end of 2024 / beginning of 2025."

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

Theralase Technologies reports promising data in bladder cancer treatment (Proactiveinvestors) - P2 | N=125 | NCT03945162 | Sponsor: Theralase Technologies Inc. | "Dumoulin-White revealed that the study now includes 72 patients, with an expectation to reach 85 by the end of the year....Dumoulin-White highlighted the strong clinical data, noting a 63% complete response rate, meaning two out of three patients are able to save their bladder and maintain their quality of life. Furthermore, nearly half of the patients experienced a durable response lasting up to 450 days, with 90% of those continuing the response beyond this period, showcasing the therapy's long-term benefits."

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

Approaches for optimization of the photodynamic therapy (PDT) efficiency with metallodrug photosensitizers in cancer treatment (ACS-Fall 2024) - 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 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 2024) - 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

Effect of metal and coligand on ground and excited state redox potentials of Ru(II) and Os(II) homoleptic complexes (ACS-Fall 2024) - "We have been particularly focused on Ru(II) and Os(II) oligothiophene-containing complexes, with our Ru-based TLD1433 having advanced to Phase 2 clinical trials for treating bladder cancer with PDT...Although there are many published reports on both photophysical and electrochemical properties for some of these homoleptic reference complexes, the methods are inconsistent and some crucial data is missing. Therefore, this study re-examines the ground and excited state redox potentials and electrochemical properties of these complexes in carefully controlled conditions and will serve as an important update to seminal compilations from past decades."

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

Theralase(R) Closes $CAN 775,000 in First Tranche of Non-Brokered Private Placement (ACCESSWIRE) - "Theralase Technologies Inc...is pleased to announce that it has successfully closed its first tranche of a Non-Brokered Private Placement ('NBPP') offering ('Offering') of units...On closing, the Corporation issued an aggregate of 3,522,729 Units at a price of $CAN 0.22 per Unit for aggregate gross proceeds of $CAN 775,000....The Company plans to use the proceeds of the financing to further the Phase II Non-Muscle Invasive Bladder Cancer ('NMIBC') clinical study currently underway, preclinical research and development of Rutherrin, working capital and general corporate purposes."

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

Nanomolar concentrations of the photodynamic compound TLD-1433 effectively inactivate numerous human pathogenic viruses. (PubMed, Heliyon) - "The presence of fetal bovine serum and virus solution turbidity reduced TLD-1433-mediated virucidal efficiency. Immunoblots of TLD-1433-treated human coronavirus indicated the treated spike protein remained particle-associated."

Journal • Herpes Simplex • Infectious Disease • Influenza • Novel Coronavirus Disease • Oncology • Respiratory Diseases

Ruvidar Enhances Efficacy of Cancer Drug (ACCESSWIRE) - "Theralase...is pleased to announce that in preclinical research, it's lead compound, Ruvidar, when combined with Bacillus Calmette-Guérin ('BCG'), was able to create a new compound with new synergistic characteristics...In cell-based experiments, the new compound, nicknamed RuBCG, was able to significantly increase the efficacy of BCG in cancer cell kill versus BCG or Ruvidar alone, when non-light activated...The mechanism of action is believed to be through a reversal of the cell wall charge of the BCG bacteria and in return a significant enhancement of bladder cancer cell kill by RuBCG....'Theralase has been able to demonstrate a significant improvement in the efficacy of BCG, through the addition of Ruvidar to form RuBCG. This new formulation eliminates the surface repelling charge of BCG cells and increases the immunogenic and cytotoxic effect on cancer cells (P=0.02 and <0.001, respectfully).'"

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

Theralase Technologies leads the way in light-activated cancer therapies (Proactiveinvestors) - "Theralase Technologies Inc...announced that its lead compound Ruvidar combined with transferrin to form the compound Rutherrin has been shown to be effective in the destruction of Non-Small Cell Lung Cancer in a preclinical study....In this model, mouse lungs are subjected to lung cancer cells which causes them to develop very aggressive and fast-growing metastatic lung tumors. The study showed that lung tumors retained Rutherrin longer than normal lung tissues."

Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Theralase(R) Release's 1Q2024 Financial Statements (ACCESSWIRE) - P2 | N=125 | Study II (NCT03945162) | Sponsor: Theralase® Technologies Inc. | "The Company plans to resubmit the pre-BTD submission to the FDA in 2Q2024/3Q2024 for FDA review of these clarifications....Theralase has commenced receiving clinical data from the CSSs with a number of patients showing a duration of their CR beyond 450 days, with some patients demonstrating CR for up to 3 years, post the primary Study Procedure...Study II Preliminary Clinical Data: For the primary objective, 63% of patients provided the Study Procedure (Study Drug activated by the Study Device) demonstrated a Complete Response...(negative cystoscopy and negative urine cytology)....For the secondary objective, 33% (approximately 1 out of 3) patients demonstrated a duration of their CR for 15 months from date of first treatment with 35% of patients demonstrating a TR."

Breakthrough therapy • Enrollment status • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Theralase brings on two Clinical Research Associates to advance bladder cancer trial (Proactiveinvestors) - "It said the two Clinical Research Associates will work with its clinical study sites to complete its Phase 2 registration bladder cancer trial of its photodynamic therapy Ruvidar, known as Study II. This will include launching new clinical study sites in Canada and the United States, enrolling all patients into the clinical study during 2024, and reviewing and analyzing the existing clinical data to ensure accuracy. They will also secure review ethics board approval and patient consent to obtain patient clinical data up to three years from the date of the primary Study Procedure and provide training and support on central pathology analysis of urine cytology and bladder biopsy pathology samples."

Trial status • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Theralase(R) Closes $CAN 750,000 Non-Brokered Private Placement (ACCESSWIRE) - "TheralaseTechnologies Inc...is pleased to announce that it has successfully closed a Non-Brokered Private Placement...offering ('Offering') of units...On closing, the Corporation issued an aggregate of 4,167,778 Units at a price of $CAN 0.18 per Unit for aggregate gross proceeds of approximately $CAN 750,200...The Company plans to use the proceeds of the financing to further the Phase II Non-Muscle Invasive Bladder Cancer ('NMIBC') clinical study currently underway, preclinical research and development of Rutherrin, working capital and general corporate purposes....All securities issued under the Offering will be subject to a four month and one day hold period from the closing date under applicable Canadian securities laws, which expires on August 25th, 2024."

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