These are tremendous results and compared to approved FDA Drugs currently on the market as seen above, we feel extremely optimistic about the possibility of RuvidarTM being approved as the “Standard of Care” for Non-Muscle Invasive Bladder Cancer in the future.
Theralase® Successfully Completes Non-GLP Toxicity Analysis for Brain Cancer
Theralase® announced that it has successfully completed its non-Good Laboratory Practices (“GLP”) preclinical toxicology analysis of Rutherrin® for Glio Blastoma Multiforme (“GBM”). GBM is the most aggressive and most common type of brain cancer.
The preclinical toxicology data collected to date has demonstrated that Theralase®’s Rutherrin® (RuvidarTM + human transferrin) PDC is able to be safely administered Intra Venously (“IV”) into brain cancer animal models and then successfully hunt, target and significantly accumulate inside GBM cells versus healthy brain cells.
When the PDC is activated by radiation therapy, such as X-ray radiation, it effectively destroys GBM tumour cells. In addition, to providing a strong cancer killing effect the technology is able to induce Immunogenic Cell Death (“ICD”) and certain anti-tumour protective responses, preventing further growth of the GBM tumour cells.
Strategic Vision:
Looking ahead, our strategic vision for 2024 is centered around our Study Drug RuvidarTM and all its Cancer destroying applications.
Theralase® Phase II Bladder Cancer Study
Theralase® is working closely with our 11 clinical study sites and are optimistic that we can enroll and treat an additional 37 patients by the end 2024, early 2025 to complete the enrolment stage of the Phase II BCG-Unresponsive NMIBC CIS study.
With these results improving as more treated patients are evaluated, Theralase continues to work towards commercialization projected for end of 2026.
Break Through Designation
As mentioned above, the Company has submitted a pre-BTD submission to the FDA and based on the FDA's feedback, the Company is currently working with the Clinical Study Sites ("CSSs"), a biostatistics organization and a regulatory organization to update the pre-BTD with clinical data clarifications identified by the FDA.
The Company plans to resubmit the pre-BTD submission to the FDA in early Q1 2024 for FDA review of these clarifications. Once the pre-BTD submission has been accepted by the FDA, the Company plans to compile a BTD submission for review by the FDA in support of the grant of a BTD approval in 1Q2024.
Theralase® Non-GLP Toxicity Analysis for Brain Cancer
Theralase® is forwarding a summary of the preclinical data to Health Canada for review and response on a GLP toxicology program to be completed by the Company by Q1 2024.
Based on the successful completion of the GLP toxicology program, Theralase® intends to commence a Phase Ia/Ib dose escalating clinical study in 2024 in patients diagnosed with GBM to determine the appropriate clinical dose of the drug from both a toxicity and tumor localization perspective.
This phase will also look at radiation activation of a single IV dose of Rutherrin®.
Following the successful completion of the Phase Ia/Ib clinical study, Theralase® plans to commence a Phase IIa/IIb clinical study in Canada and the United States focused on enrolling and treating patients diagnosed with recurrent GBM, with multiple radiation activated doses of Rutherrin®.
Communication and Transparency:
Our commitment to transparent communication remains unwavering. We will continue to provide regular updates on our progress, challenges, and strategic initiatives throughout the year.
Leadership Highlights:
Theralase® Appoints Roger DuMoulin-White as President and Chief Executive Officer
Theralase is pleased to announce that Mr. DuMoulin-White, the founder of Theralase has been appointed as President and Chief Executive Officer (“CEO”) of the Company.
Dr. Kaothar Lbiati, M.D.,M.Sc. appointed as New Independent Director
Theralase is “…thrilled to welcome an individual of this caliber to our Board. Dr. Lbiati possesses a wealth of international experience across all aspects of drug development, from: clinical research to medical affairs, marketing to commercialization of various drug candidates. ...”
Investor Relations Initiatives:
Stay tuned for enhanced investor relations initiatives, such as results from the 6 most recently treated patients.
Thank You:
We appreciate the trust you have placed in us, and we are enthusiastic about the opportunities that 2024 holds for Theralase Technologies. Your continued support is integral to our success.
If you have any questions, suggestions, or if there's anything specific you would like to know, please feel free to reach out to our Investor Relations team at 416-699-5273 X229.
Wishing you a prosperous and fulfilling 2024!
Sincerely,
Matthew Perraton FMA, DFSA, Pro. Dir.
Director/Investor Relations
Theralase Technologies (TSXV: TLT, OTCQB: TLTFF)
Work: 416-699-LASE (5273) x229
Toll Free (Canada and the US): 1-866-THE-LASE (843-5273)
mperraton@theralase.com
www.theralase.com