A Toronto based clinical-stage biopharmaceutical company is quickly advancing on what may prove to be one of the safest and most effective cancer treatments ever developed. Theralase Technologies Inc. (“Theralase”) is conducting a pivotal Phase II clinical study, with a primary objective of efficacy, of a cutting-edge anti-cancer treatment that utilizes laser light activated anti-cancer drugs; known as Photo Dynamic Compounds (“PDCs”), to destroy cancer cells from the inside out. In other words, these PDCs are able to penetrate preferentially into cancer cells, leaving healthy cells intact, and when laser light activated destroy the cancer cells safely and effectively with minimum to no side effects. Theralase is currently investigating these PDCs in the destruction of Non-Muscle Invasive Bladder Cancer (“NMIBC”) via a pivotal Phase II clinical study.
Founded in 1994,Theralase commenced the research, development and commercialization of therapeutic lasers for the elimination of knee pain and continues this business today; however, the Company pivoted in 2004, when it in-licensed its first platform of PDCs and commenced the research and development of this game-changing technology. After fifteen years of research and development and the in-license of two additional platforms of PDCs, Theralase has now optimized both the PDCs and the laser systems used to activate them to safely and effectively destroy NMIBC. The successful results on NMIBC patients obtained from a recently completed Phase Ib clinical study attest to this fact.
Photo Dynamic Therapy (“PDT”) is a form of phototherapy; whereby, non-toxic light-sensitive compounds, also known as photosensitizers or PDCs, are exposed to laser light to “activate” them. When these photosensitizers are “activated” by laser light, they rapidly produce a violent form of oxygen known as singlet oxygen or Reactive Oxygen Species (“ROS“), which quickly overwhelms the cancer cell forcing it through a natural cell death, known as apoptosis. Why is this important? Firstly, other than Bacillus Calmette Guerin (“BCG”), which has a known 30% unresponsive rate in the first year post-treatment, and is presently in short supply, there is no other effective Health Canada or FDA approved drug available to treat NMIBC; hence for BCG-Unresponsive patients, the standard of care is a radical cystectomy (complete removal of bladder and associated structures) Secondly, Theralase PDT has been proven to be safe and effective in the treatment of BCG-Unresponsive NMIBC patients, according to the data collected in the Phase Ib clinical study, providing a treatment which is minimally invasive with extremely short recovery times; hence less pain and less loss of valuable time for the patients.
In 2019, it is estimated that there will be approximately 80,470 new cases of bladder cancer in the US 1 and approximately 11,838 new cases of bladder cancer in Canada 2. Bladder cancer is the 4th most common cancer in men and 17th in women 1. So, if the Theralase PDT technology does prove to be safe and effective in the destruction of this deadly form of cancer, through the successful completion of a pivotal Phase II clinical study, we may someday soon hope and pray to put a major dent in this disease for future generations to come.
Shushu Feng
1 American Cancer Society https://www.cancer.org/cancer/bladder-cancer/about/key-statistics.html
2 Canadian Cancer Society – Cancer Stats 2019