Theralase Technologies Inc. announced that it's lead compound, RuvidarTM, combined with transferrin to form the compound Rutherrin®, has been proven effective preclinically in the destruction of Non-Small Cell Lung Cancer ("NSCLC"). Theralase recently completed experiments in NSCLC, using a Lewis Lung Cancer ("LLC1") orthotopic model. In this model, mouse lungs are subjected to lung cancer cells, which induces these mice to develop very aggressive, fast growing and metastatic lung tumours.

lung tumours retained Rutherrin longer than normal lung tissues (p> 0.01), leading to a substantially improved selectivity of Rutherrin® to target lung cancer. Theralase® has demonstrated that all animals treated with x-ray activated Rutherrin® are currently alive; unfortunately, this is not the case for mice that received x-ray treatment only. Tumour volume analysis in mice after tumour inoculation and treatment with either radiation only or combined treatment of Rutherrin ® and radiation treatment.

There is a significant delay in tumour progression in mice treated with x-ray activated Rutherrin® versus with radiation alone (p> 0.001). In fact, in mice treated with x-ray activated Rutherrin®, the tumour is notably regressing /being destroyed over time. The results presented represent Theralase®'s commitment to unlocking the inherent value of the patented x-ray activated Rutherrin Anti-Cancer Therapy ("ACT") platform for the benefit of the millions of patients, who are diagnosed with difficult to treat cancers at various disease stages and risk factors.

Patients diagnosed with cancers, such as: Glio Blastoma Multiforme ("GBM") or NSCLC are faced with limited treatment options, with this new research hopes to solve. In several, well established, orthotopic animal models; specifically: rat GBM brain cancer and mouse LLC1 lung cancer, Theralase® has demonstrated a significant destruction of cancer cells (p>0.001) and an inhibition in their regrowth. In addition, the Theralase® preclinical research team is researching the application for x-ray activated Rutherrin® to be IV administered for numerous other cancers; including: pancreatic cancer, prostate cancer, kidney cancer and colorectal cancer.

Theralase® intends to commence a Phase Ia dose escalating clinical study in 4Q2024 for patients diagnosed with GBM and NSCLC, to determine the appropriate clinical dose of Rutherrin® to be administered from a safety perspective; including: toxicity and tumour localization. This research may expand to include: pancreatic cancer, prostate cancer, kidney cancer and colorectal cancer, based on capitalization. Following successful completion of Phase Ia, a Phase Ib study will be commenced to determine patient efficacy, using x-ray activated Rutherrin®.

Pending the successful completion of the Phase Ia/Ib clinical study, Theralase plans to commence a Phase II clinical study in Canada and the United States focused on enrolling and treating patients diagnosed with GBM and NSCLC, which as previously mention may expand to include patients diagnosed with pancreatic cancer, prostate cancer, kidney cancer and colorectal cancer, subject to capitalization. Lung cancer is the leading cause of cancer mortality in men aged =40 years and women aged =60 years, causing more deaths than any other dominant cancer of men or women. The demographic (80 to 85%) of newly diagnosed cases of lung cancer are NSCLC.

Currently, patients with NSCLC are treated with the three conventional therapeutic methods; including: surgery, chemotherapy and radiation. In the latter case, patients are subjected to localized irradiations of the tumor with large doses of x-ray or gamma rays, which are divided into smaller fractions applied over several weeks. Such irradiations, often combined with chemotherapy, can lead to more or less durable remissions; however, the prognosis for NSCLC patients, which are often diagnosed at an advanced stage of the disease, remains poor and NSCLC continues to be the leading cause of cancer death worldwide.