Theralase Advances Its Pivotal Phase 2 Non-Muscle Invasive Bladder Cancer Study

Theralase Technologies Inc. recently  announced that Nova Scotia Health Authority (NSHA) Research Ethics Board (REB) has approved the commencement of a Pivotal Phase 2 Non-Muscle Invasive Bladder Cancer (NMIBC) Clinical Study to enroll and treat patients who present with Carcinoma In-Situ (CIS) and who are considered Bacillus Calmette Guerin (BCG)-Unresponsive or are intolerant to BCG Therapy (Study II).

The Nova Scotia provincial cancer rates are among the highest in Canada. It is estimated for 2019 in Nova Scotia that 6,700 people were diagnosed with cancer, and 2,900 people died of cancer with bladder cancer cases counting for approximately 5% of cancer diagnosis.

The NSHA institution is affiliated with the Urology Department at Dalhousie (UDD) University of Medicine, an innovative leader in urological oncology research. UDD evaluates new technologies designed to improve the lives of people suffering from urological cancers. Each year, more than 300 people are diagnosed with bladder cancer and seek attention in Nova Scotia. UDD doctors have extensive experience providing quality of care for bladder cancer patients while maintaining an active research role to enhance overall patient care.

Dr. Ricardo Rendon, MD, FRCSC, Professor in the Department of Urology and Director of Clinical Trial of Dalhousie University in Halifax stated that “We are excited to work with Theralase for the NMIBC clinical trial. Tackling cancer is a crucial topic and a priority for this region, and I am pleased that NSHA is able to contribute to the growth of innovative cancer research by taking part in this leading Pivotal PhotoDynamic Therapy (PDT) study.”

With the addition of NSHA, the company now has four sites open for patient enrollment and treatment, specifically, NSHA, London Health Science Centre (LHSC), University Health Network (UHN) and McGill University Health Centre (MUHC). In addition, the company has approximately 16 clinical study sites located in Canada and the US that are at various stages of the on-boarding process. The company is strategically targeting clinical sites throughout Canada and the US [subject to FDA Investigational New Drug (IND) approval] that serve large populations or have the demographics to support patient enrollment and treatment.

Shawn Shirazi, PhD, CEO of Theralase, stated that “I am pleased to announce the addition of NSHA and Dr. Rendon as Principal Investigator. Dr. Rendon is considered an expert in the field with a clinical focus on all areas of uro-oncology. To date, 10 patients have been treated, which represents a 10% completion rate of patient enrollment, and about a 50% completion rate in relation to the interim analysis milestone set at treating 20 to 25 patients. By continuing to advance Study II, we hope to bring this treatment to all Canadian patients suffering from this disease and look forward to starting our clinical study in the US, subject to regulatory approval.”

The Phase 2 NMIBC Clinical Study utilizes the Therapeutic Dose (0.70 mg/cm²) of TLD-1433, focusing on the treatment of approximately 100 BCG-Unresponsive NMIBC patients presenting with CIS in approximately 20 clinical study sites located in Canada and the US. Study II will have a primary endpoint of efficacy (measured by CR) at any point in time, a secondary endpoint of duration of CR at approximately 360 days post-initial treatment and a tertiary endpoint of safety measured by incidence and severity of adverse events grade 4 or higher that do not resolve within 360 days post-initial treatment. To date, 4 clinical study sites are active for enrollment and 10 patients have been treated in the Study II.

In 2020, an estimated 81,400 adults (62,100 men and 19,300 women) will be newly diagnosed with bladder cancer in the US. Among men, bladder cancer is the fourth most common cancer. It is estimated that 17,980 deaths (13,050 men and 4,930 women) from this disease will occur in 2020.³ The bladder cancer market is expected to triple in size to around $1.1 billion by 2025.

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. For more information, visit www.theralase.com and www.sedar.com.