On September 27, 2023 Theralase reported that it has successfully completed its non-Good Laboratory Practices ("GLP") preclinical toxicology analysis of Rutherrin for Glio Blastoma Multiforme ("GBM") (Press release, Theralase, SEP 27, 2023, View Source [SID1234636145]). GBM is the most aggressive and most common type of brain cancer.

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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.

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 1Q2024.

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 tumour 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.

Dr. Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer of Theralase stated, "Theralase’s scientific team has worked tirelessly to research and develop Rutherrin as an IV PDC that post administration is able to be activated by radiation therapy to hunt, target and destroy GBM. The GLP toxicology program that Theralase is completing will lay the groundwork for Rutherrin to be IV administered for numerous other cancers; including: Non-Small Cell Lung Cancer ("NSCLC"), pancreatic cancer, prostate cancer, kidney cancer and colorectal cancer. I look forward to commencing the clinical study program evaluation of this versatile and effective drug in 2024."

Mr. Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, President and Chief Executive Officer of Theralase stated, "Dr. Mandel and his scientific team have conducted numerous in-vitro and in-vivo experiments to compile this body of preclinical work to be able to bring Rutherrin to the GLP toxicology analysis stage and then pending successful completion onto clinical development. The use of human transferrin in animal models has proven difficult to overcome, but the hard work and dedication of the Theralase team have successfully completed this work to bring Theralase to the next step."