Source: Theralase Technologies Inc.
  • Theralase Technologies’ (TLT) Phase Ib Non-Muscle Invasive Bladder Cancer clinical study has been published in the European Urology Open Science Journal
  • EUOS covers research in the urological field, including clinical, basic and translational research
  • The publication is entitled, “A Phase 1b Clinical Study of Intravesical Photodynamic Therapy in Patients with Bacillus Calmette-Guérin–unresponsive Non–muscle-invasive Bladder Cancer
  • Photo Dynamic Therapy was well tolerated and demonstrated safety and potential efficacy, prompting Theralase to undertake a multi-site, pivotal Phase II NMIBC Clinical Study
  • Theralase is a clinical-stage pharmaceutical company dedicated to the research and development of light-activated photodynamic compounds
  • Theralase Technologies Inc. (TLT) opened trading at C$0.295

Theralase Technologies’ (TLT) Phase Ib Non-Muscle Invasive Bladder Cancer clinical study has been published in the European Urology Open Science Journal.

The European Urology Open Science (EUOS) is dedicated to the publication of high quality, innovative research that will benefit patients with urological conditions. EUOS covers research in the urological field, including clinical, basic and translational research.

The publication is entitled, “A Phase 1b Clinical Study of Intravesical Photodynamic Therapy in Patients with Bacillus Calmette-Guérin–unresponsive Non–muscle-invasive Bladder Cancer” and states, “Although limited by the small sample size typically inherent in phase 1 trials, we feel that the photosensitizer TLD-1433 and the delivery device TLC-3200 hold promise for the treatment of NMIBC. In this study, Photo Dynamic Therapy was well tolerated and demonstrated safety and potential efficacy, thus warranting further study.”

As a result, the Medical and Scientific Advisory Board has agreed that Theralase should further investigate PDT in a multi-site, pivotal Phase II NMIBC Clinical Study (Study II). Study II is currently underway at five clinical study sites in Canada and seven sites in the United States, with 41 patients treated to date.

Girish Kulkarni, M.D., Ph.D., lead principal investigator of the Study at the Divisions of Urology and Surgical Oncology, Department of Surgery, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada stated,

“I am delighted that the high-quality research conducted at UHN, in conjunction with Theralase, was successful, in this challenging patient population, both for safety and potential efficacy. Patients with BCG-Unresponsive NMIBC are a difficult patient population to treat since they have unfortunately failed the standard of care, BCG. Many also failed other investigational therapies prior to being treated with Theralase’s PDT. The clinical data that we collected was robust and clinically relevant. I am fully supportive of the multi-site Phase II NMIBC clinical study, currently in progress, to further investigate the role of PDT in BCG-Unresponsive NMIBC.”

Dr. Arkady Mandel M.D., Ph.D., D.Sc., Interim Chief Executive Officer and Chief Scientific Officer of Theralase added,

“The company is very pleased to share the study clinical data that has been peer-reviewed and published in EUOS. Indeed, the publication of clinical results in a peer reviewed journal like EUOS validates the quality of the Theralase research and the professionalism of the clinical study team, who conducted it. As a direct result of the success of this initial study, Theralase elected to undertake Study II, which I am happy to report is proceeding well.

Based on the strength of the clinical data collected and the consistently high safety and efficacy profile of Theralase’s PDT, I am confident that TLD-1433-based therapy has the potential to become the next gold-standard in the treatment of BCG-Unresponsive patients.”

Theralase is a clinical-stage pharmaceutical company dedicated to the research and development of light-activated photodynamic compounds.

Theralase Technologies Inc. (TLT) opened trading at C$0.295.

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