Theralase Announces Health Canada Approves Amended Clinical Trial Application

Theralase Technologies Inc. recently announced that Health Canada has issued a No Objection Letter (NOL) for an amended Clinical Trial Application (CTA) for its Phase 2 Non-Muscle Invasive Bladder Cancer (NMIBC) clinical study (Phase 2 Study).

The amended CTA was submitted to Health Canada to update the current CTA, for an optimized design of the TLC-3200 medical laser system (Study Device) and is subject to Investigational Testing Authorization (ITA) by Health Canada and Review Ethics Board (REB) approval by each Study II site before being used in the Phase 2 Study. The amended CTA will not impede the Phase 2 Study as patients will continue to be treated with the Study Drug and Study Device under the current CTA, ITA and REB approvals until the Company receives the new ITA and REB approvals.

The Study Device will be used to activate the PDC TLD-1433 (Study Drug) in the bladder in the Phase 2 Study.

Study Device optimizations, include:

-A more powerful laser engine (reduces patient treatment times)

-Higher precision and repeatability in laser light detection (higher patient efficacy)

-Increased robustness in laser power capacity and operator handling (higher patient safety)

-Reduced physical size allowing for the use of a flexible cystoscope (higher patient safety)

-An ability to detect laser emitter movement during the Study Procedure (higher patient safety)

-An optimized graphical user interface and system feedback control to allow the principal investigator to operate an “on-off” operation to deliver an effective Study II treatment

Shawn Shirazi, PhD, CEO – Drug Division, Theralase, said “A new CTA was submitted to Health Canada in order to provide updates to the Phase 2 Study clinical protocol, which included optimizations of the Study Device. Receipt of the NOL from Health Canada is subject to receipt of a pending ITA by Health Canada and REB approval from each clinical study site that will participate in the Phase 2 study, will allow the company to supply these study sites with the most optimized, technologically advanced Study Device. In the interim, prior to these approvals, our primary study site is actively enrolling patients and if a patient were to be scheduled for treatment, prior to the new ITA and REB approval, they could effectively be treated with the Study Drug and Study Device currently under CTA, ITA and REB approval. This is a significant milestone for the company, as we continuously strive to bring the most advanced technology to the clinical sites to provide safer and more effective technology in the treatment of their patients.”

Dr. Shirazi continued by stating “Theralase is currently working to register up to an additional 19 clinical study sites this year, subject to regulatory and clinical study site approvals. The study sites include Canadian, US, and European Union oncology institutions. Registration of the US and EU clinical study sites, will be subject to the filing and regulatory approval of our Phase 2 study by the US FDA and European Medicines Agency regulatory authorities. Theralase has a patented Study Drug and Study Device that when combined, have proven to be safe and effective in the treatment of patients inflicted with Bacillus Calmette Guérin-Unresponsive NMIBC. Our primary focus is and remains the successful completion of this pivotal Phase II study; however, the company, through Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer of Theralase continues to research and develop our PDCs for the treatment of other oncological indications, such as Glioblastoma Multiforme (GBM) , Non-Small Cell Lung Cancer (NSCLC) and most recently non-melanoma related skin cancer.”

Kipton Lade, BSc, MSc, MBA, CEO – Device Division, Theralase, added “The Company is pleased that it was able to execute on the scope of engineering improvements to the TLC-3200, without impeding the Phase 2 Study. Our internal and external engineering teams have optimized the Study Device to enhance outpatient treatments, through both hardware and software upgrades, allowing:

-Shorter patient treatment times

-Increased patient efficacy

-Increased patient safety

We hope that these optimizations translate into a successful completion of the Phase II clinical study for the Company and potentially in the future allow patient treatments to be performed in a non-operating room environment.”

There are an estimated 24,000 new cases of malignant gliomas diagnosed in the US annually, with more than 17,000 deaths. In the majority of cases, they recur following initial treatment, especially for GBM, the most common and lethal form of brain cancer. Most patients do not survive beyond 2 years, post diagnosis.

Lung cancer is by far the leading cause of cancer death among both men and women. Out of all types of lung cancer, NSCLC accounts for 80 to 85% of cases. The American Cancer Society’s estimates for lung cancer in the US for 2019 are approximately, 228,150 new cases of lung cancer, and approximately 142,670 deaths from lung cancer.

One in five Americans will develop skin cancer by the age of 70. More people are diagnosed with skin cancer each year in the US than all other cancers combined. More than 5.4 million cases of non-melanoma skin cancer were treated in over 3.3 million people in the US in 2012. The annual cost of treating skin cancers in the US is estimated at $8.1 billion: about $4.8 billion for non-melanoma skin cancers and $3.3 billion for melanoma.

Theralase is a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds and their associated drug formulations intended to safely and effectively destroy various cancers.