Theralase(R) Demonstrates That X-Ray-Activated Rutherrin(R) Is Significantly More Effective than Radiation Alone in the Destruction of Muscle Invasive Bladder Cancer

Executive Summary

• Theralase® Technologies released pre‑clinical data showing that X‑ray‑activated Rutherrin® markedly enhances radiation‑induced killing of muscle‑invasive bladder cancer (MIBC) in mouse models.
• In vitro, Rutherrin® combined with 2.5 Gy X‑ray produced significantly greater cell death than radiation alone; in vivo, the combination achieved complete tumor clearance at a cumulative 25 Gy dose, whereas radiation alone resulted in persistent tumors and 50 % mortality.
• The company plans to initiate a Phase 0/I/II adaptive clinical trial of Rutherrin® (with or without chemo/immunotherapy) in MIBC patients, pending regulatory approval.

Key Details

• Pre‑clinical Model: Orthotopic MIBC mouse model using MBT‑2 cells injected into the bladder muscle layer.
• In Vitro Findings: Rutherrin® + 2.5 Gy X‑ray → significantly higher cell death vs radiation alone (Figure 1).
• Tumor Uptake: Intravenous Rutherrin® resulted in ~4× higher concentrations in tumor tissue versus normal bladder, indicating selective uptake (Figure 3).
• In Vivo Study:
• Treatment regimen – repeat intravenous Rutherrin® plus fractionated radiation totaling 25 Gy.
• Outcome at Day 35: All mice receiving Rutherrin® + radiation survived with complete tumor clearance; radiation‑only group showed 50 % humane‑endpoint mortality and continued tumor growth in the remainder (Figures 4 & 5).
• Planned Clinical Development: Phase 0/I/II adaptive study to evaluate X‑ray‑activated Rutherrin® as a radiosensitizer for MIBC, potentially combined with chemotherapy or immunotherapy, subject to regulatory approval.
• Clinical Rationale: Current MIBC standard of care (cisplatin‑based neoadjuvant chemo + radical cystectomy) has high recurrence rates (20 %–70 %). Tri‑modal therapy is an emerging bladder‑preserving option but limited by patient selection. Rutherrin® could provide a non‑surgical, radiation‑enhanced alternative.

Notable Quotes

• Mark Roufaiel, PhD – Research Scientist: “These preclinical findings demonstrate that Rutherrin® selectively accumulates in MIBC tumours versus healthy bladder tissue and significantly enhanced the therapeutic effect of radiation…complete tumour clearance…even under low radiation dosing conditions.”
• Arkady Mandel, MD, PhD, DSc – Chief Scientific Officer: “Preclinical data collected supports the clinical opportunity of employing X‑Ray‑Activated Rutherrin® in the treatment of difficult‑to‑treat cancers…MIBC.”
• Roger DuMoulin‑White – President & CEO: “The combination of selective tumour uptake, demonstrated X‑Ray enhancement in vitro, accelerated tumour regression and complete tumour destruction in vivo at low radiation doses collectively supports the executive decision … to pursue clinical development of Rutherrin® as a radiation sensitizer.”