Innovations in treating cancer have improved dramatically in the past 50 years. However, medical research continues to move toward an ultimate goal: finding a cure. As it happens, one Toronto-based company is now very close to making this goal a reality.
Theralase Technologies (TLT:CA) , a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, has made a great deal of progress moving towards Phase Ib human clinical trials. Pending Health Canada approval of a Clinical Trial Application (“CTA”) and Investigational Testing Authorization (“ITA”), in addition to Princess Margaret Cancer Center and University Health Network (“UHN”) Research Ethics Board (“REB”) approval, Theralase plans to commence enrolling patients who are inflicted with Non-Muscle Invasive Bladder Cancer (“NMIBC”) into a Phase Ib clinical study at UHN to prove the primary objective of safety and tolerability, with an exploratory objective of efficacy.
A number of milestones have been met by the company in the month of September in order to obtain Health Canada approval required to commence NMIBC human trials.
The protocols that Theralase has met in the last 30 days include:
● Demonstration of Stability of Lead Drug – Theralase demonstrated three month long term stability, and accelerated stability of its lead Photo Dynamic Compound (“PDC”), TLD-1433, currently being developed by the company for the treatment of NMIBC. Demonstrating long-term stability and accelerated stability of a drug to be used in human clinical testing is essential to prove that the potency and/or efficacy of the drug is not affected during a prolonged shelf life.
● Completion of GMP Manufacture of Lead Drug – Theralase completed manufacture of its lead PDC, TLD-1433 in compliance with Good Manufacturing Practice (“GMP”) standards. Completion of the GMP manufacturing of TLD-1433 is a major milestone for the company, and is a prerequisite for a CTA application. Supporting data includes a Chemistry, Manufacturing, and Control (“CMC”) analysis detailing pertinent specifications of the drug.
● Research Demonstrates Lead Drug Also Effective for Muscle Invasive Bladder Cancer – Theralase’s latest research demonstrated that its lead PDC, TLD-1433, in addition to being indicated for the treatment of NMIBC, may also be effective for the treatment of Muscle Invasive Bladder Cancer (“MIBC”). The latest research involved testing the Photo Dynamic Therapy (“PDT”) of TLD-1433 in an orthotopic rat bladder tumor model.
● Successful Completion of GLP Toxicology Analysis of Lead Drug – Theralase has successfully completed the toxicology analysis of its lead PDC, TLD-1433, in compliance with Good Laboratory Practice (“GLP”) standards. This milestone is critical for a CTA submission to Health Canada.
● Completion of Clinical Protocol – Theralase has completed the Clinical Protocol and Investigator’s Brochure detailing the application of its lead light activated PDC, TLD-1433 in the treatment of NMIBC. The Clinical Protocol and Investigator’s Brochure details the Standard Operating Procedures (“SOPs”) that a uro-oncologist must follow to administer a PDT treatment using TLD-1433 to a patient who is inflicted with NMIBC.
● Completion of Detailed Information on the TLC-3000B Laser System – Theralase has completed detailed information on how the TLC-3000B Laser System will be used to activate the company’s lead light-activated PDC, TLD-1433 in the treatment of NMIBC. Information regarding the TLC-3000B Laser System includes: safety information, medical device description, specifications, risk analyses, SOPs and recommended maintenance procedures that a uro-oncologist would follow to administer a PDT treatment using light activated TLD-1433 to a patient afflicted with NMIBC.
● Submission of Clinical Trial Application to Health Canada for Approval – Theralase has submitted a CTA for its anti-cancer technology to Health Canada for approval. Pending Health Canada approval of the CTA approval, Theralase plans to commence enrolling patients inflicted with NMIBC into a Phase Ib clinical study at UHN to prove the primary objective of safety and tolerability, with an exploratory objective of efficacy.
● Submission of Investigational Testing Authorization to Health Canada – Theralase has submitted an ITA for its anti-cancer technology to Health Canada for approval. The ITA details information about the proprietary Theralase TLC-3200 Oncology Laser System, which Theralase plans to use to activate the Company’s lead PDC, TLD-1433, to destroy NMIBC.
● Submission of Anti-Cancer Technology to Research Ethics Board – Theralase has submitted its anti-cancer technology to the REB of UHN for approval. The REB is responsible for reviewing the anti-cancer technology and assessing it from a clinical viewpoint. The anti-cancer technology consists of the company’s lead PDC, TLD-1433, which is light-activated by the proprietary Theralase TLC-3200 Oncology Laser System for the treatment of NMIBC.
● Completion of GMP Manufacture of Second Batch of Lead Drug– Theralase has completed manufacture of a second batch of its lead PDC, TLD-1433 in compliance with GMP standards. This milestone demonstrates Theralase’s ability to consistently and reliably manufacture its lead light activated drug in the same purity and yield as the original GMP batch. Consistency in manufacture of TLD-1433 is essential to prove to regulatory agencies that a drug intended for the treatment of NMIBC can be reliably produced to GMP quality standards.
“Theralase has now completed all submissions required by Health Canada and UHN in order to evaluate and approve its proposed PDT treatment of NMIBC,” said Roger Dumoulin-White, President and CEO of Theralase. “Pending approval, Theralase will now embark on one of the most important milestones of its existence, proving the safety, tolerability and efficacy of its cutting-edge anti-cancer technology in the destruction of NMIBC.”
September was filled with milestones – not just for Theralase Technologies, but for the field of cancer research and treatment. With progress moving at such a rapid pace, it seems entirely clear that a cure for cancer is now within reach.
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