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®.