17:20:58 EDT Mon 13 May 2024
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Theralase Technologies Inc
Symbol TLT
Shares Issued 216,502,675
Close 2023-09-26 C$ 0.215
Market Cap C$ 46,548,075
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Theralase completes non-GLP toxicology analysis for GBM

2023-09-27 10:20 ET - News Release

Mr. Roger DuMoulin-White reports

THERALASE(R) SUCCESSFULLY COMPLETES NON-GLP TOXICITY ANALYSIS FOR BRAIN CANCER

Theralase Technologies Inc. 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 have demonstrated that Theralase's Rutherrin (Ruvidar plus human transferrin) PDC is able to be safely administered intravenously (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 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 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 postadministration 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."

Roger DuMoulin-White, BSc, PEng, ProDir, 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."

About Theralase Technologies Inc.

Theralase is a clinical-stage pharmaceutical company dedicated to the research and development of light- and radiation-activated compounds, their associated drug formulations, and the light systems that activate them, with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses.

We seek Safe Harbor.

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