Anti cancer Therapy
Destroying Cancer at the Speed of Light®
Theralase® is laser focused on advancing the cutting-edge Anti-Cancer Therapy (“ACT”) towards commercialization, providing an alternative treatment methodology for Non-Muscle Invasive Bladder Cancer (“NMIBC”) cancer patients globally.
Theralase® is dedicated to safely and effectively destroying cancer through the research, development and commercialization of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations.
We are a clinical stage biopharmaceutical company. Our Photo Dynamic Therapy (“PDT”) division focuses on developing Anti-Cancer Therapy (“ACT”) treatments by utilizing light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations to destroy cancer cells.
Photo Dynamic Therapy ("PDT") employs non-toxic light-sensitive compounds that are absorbed preferentially by cancer cells, versus health cells, and when laser light activated, these compounds produce a violent form of oxygen known as singlet oxygen or Reactive Oxygen Species ("ROS"), which oxidizes the cancer cell inducing natural cell death, known as apoptosis.
Theralase®’s mandate is to research, develop and commercialize the Anti-Cancer Therapy (“ACT”) technology in the destruction of various cancers. Our patented Photo Dynamic Compounds ("PDCs"), once absorbed by cancer cells, are laser light activated with proprietary laser systems to destroy cancerous cells safely and effectively.
Photo Dynamic Therapy
PDT uses PDCs (light-sensitive compounds) that when exposed to laser light are able to produce a violent form of oxygen known as singlet oxygen or Reactive Oxygen Species (“ROS”), which causes oxidative stress to cancer cells and induces natural cell death, known as apoptosis.
Theralase® through its research, development and collaboration with world-renowned researchers has enhanced and modernized traditional PDT, optimizing the technology and increasing the potential of PDT to treat a broad range of diseases and overcome the safety and efficacy limitations of current cancer treatments.
Theralase® is conducting a pivotal Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study, with a primary endpoint of efficacy, secondary endpoint of duration of efficacy and tertiary endpoint of safety.
Theralase is conducting preclinical research in using its patented PDCs in the treatment of Glio Blastoma Multiforme (“GBM”) ( a deadly form of brain cancer) and Non-Small Cell Lung Cancer (“NSCLC”).
Phase Ib NMIBC Clinical Study
With strong safety signals and a 67% Complete Response (“CR”) rate at 540 days; the Phase Ib NMIBC Clinical study (“Study I”) was successfully completed, meeting all three endpoints. To date, Study I demonstrates the best clinical results in a Phase Ib human study for NMIBC and is very encouraging to be used as a potential treatment for patients diagnosed with NMIBC.
The Study I data further validates our understanding that even a single treatment of Theralase’s ACT is able to lead to CR at 540 days post treatment for patients presenting with Bacillus Calmete Guérin (“BCG”)-Unresponsive NMIBC. Albeit in a small patient group, 2/3 patients enrolled and treated in Study I, treated at the Therapeutic Dose, have demonstrated no tumour recurrence, progression or presence of NMIBC disease at the 540 day clinical and cystoscopy assessment.
Consequently, Theralase Technologies’ Anti-Cancer Therapy continues to be further evaluated in a pivotal Phase II NMIBC clinical study (“Study II”).
Principle Investigator at University Health Network, Princess Margaret Cancer Centre, Dr. Girish Kulkarni MD, Surgeon-Scientist affiliated with the Department of Surgery, Faculty of Medicine at the University of Toronto discusses the successful completion of the first human clinical study for Theralase’s Anti-Cancer Study Drug, TLD-1433.
Table of Clinical Study Sites
|Clinical Study Sites||Principle Investigator|
|University Health Network (“UHN”), Princess Margaret Cancer Centre (“PMCC”) (Toronto, Ontario)||Dr. Girish Kulkarni, MD, PhD, FRCSC|
|McGill University Health Centre (“MUHC”) (Montreal, Quebec)||Dr. Wassim Kassouf, MD, CM, FRCSC|
|London Health Sciences Centre Centre (“LHSC”) (London, Ontario)||Dr. Joseph Chin, MD, FRSC|
|Nova Scotia Health Authority (“NSHA”) (Halifax, Nova Scotia)||Dr. Ricardo Rendon, MD, FRCSC|
|University of British Columbia Columbia (“UBC”) (Vancouver, British Columbia)||Dr. Peter Black, MD, FRCSC|
|Virginia Urology (“VU”) (Richmond, Virginia)||Dr. Eugene Kramolowsky II, M.D.|
|Urology Associates P.C. (“UA”) (Nashville, Tennessee)||Dr. Gautam Jayram, M.D.|
|MidLantic Urology (“MLU”) (Bala Cynwyd, Pennsylvania)||Dr. Laurence H. Belkoff, DO, MSc. FACOS|
Phase II NMIBC Clinical Study
As the frontrunner in personalized Anti-Cancer Therapy (“ACT”) Photo Dynamic Therapy (“PDT”) treatments for patients diagnosed with Non-Muscle Invasive Bladder Cancer (“NMIBC”), the pivotal Phase II NMIBC clinical study (“Study II”) has the potential to become the next gold standard for NMIBC treatment.
Study II utilizes the Therapeutic Dose (0.70 mg/cm2) of the Study Drug (TLD-1433) and focuses on the enrollment and treatment of approximately 100 Bacillus Calmette Guérin (“BCG”)-Unresponsive NMIBC patients presenting with Carcinoma In-Situ (“CIS”) in approximately 15 clinical sites located in Canada and the US, with a primary endpoint of efficacy at any point in time, a secondary endpoint of duration of CR and a tertiary endpoint of safety.
In Study II, all patients will receive two Study Treatments (Day 0 and Day 180).
To date, 14 patients have been enrolled and treated in Study II.
Fast Track Designation (“FTD”) was granted by the US Food and Drug Administration (“FDA”) to Theralase® in November 2020. In order to potentially qualify for Breakthrough Therapy Designation (“BTD”) the Company has been advised by the FDA, to provide clinical assessment data for the primary, secondary and tertiary endpoints for a minimum of 20 patients treated at the Therapeutic Dose level.
Theralase® may also be eligible for Accelerated Approval (“AA”) by the FDA should the clinical results of Study II support a clinically meaningful improvement in safety and/or efficacy over current NMIBC treatment therapy.
The Potential of Photo Dynamic Therapy
Theralase’s® ACT platform has demonstrated the potential to provide a safe and effective treatment alternative to patients stricken with NMIBC. Theralase® is laser focused on researching, developing and commercializing light activated PDCs and their associated drug formulations to safely and effective treat various cancers.
Theralase® is advancing its PDC pipeline to include preclinical research into GBM and NSCLC.
|Discovery||Preclinical||Phase I||Phase II||Phase III|
Non-Muscle Invasive Bladder Cancer
Glioblastoma multiforme ("GBM")
Non-Small Cells Lung Cancer ("NSCLC")
SARS - CoV-2 - COVID-19
Behind the Science
Theralase® possesses expert scientific, clinical and engineering in-house experience in the research, development and commercialization of light-activated Photo Dynamic Compounds (“PDCs”), the laser systems that activate them and the methodology used to destroy cancer, bacteria and viruses.
These core competencies allow Theralase® to develop targeted and personalized medical technology platforms, essentially providing a one-stop solution to meet patient needs.
Theralase®’s ACT platform originates from > 17 years of scientific, preclinical and clinical research.
To protect and increase the value of the Company, Theralase® has heavily invested in a comprehensive Intellectual Property (“IP”) strategy to protect and safeguard the Company’s technology through issued international patents and patents pending.
IMPORTANT INFORMATION FOR PATIENTS
If you are a patient interested in participating in the Phase II NMIBC clinical study (“Study II”), please feel free to contact Theralase® or the nearest participating clinical study site for more information.
If enrolled in Study II, there is a no charge for participation for patients who qualify; however, your urologist will need to contact the principal investigator to provide confidential information about your NMIBC to ensure you meet the clinical study guidelines.
For patients or practitioners wishing to learn more about Study II, please visit ClinicalTrials.gov and search for "Theralase" or by the National Clinical Trial Number: NCT03945162.
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