Light-Activated Ruvidar and Interferon Demonstrate Enhanced Efficacy

Executive Summary

• Theralase® Technologies reports that in‑vitro studies show a 50–65 % increase in bladder cancer cell kill when light‑activated Ruvidar® is combined with recombinant human interferon alpha‑2b (rhIFNα2b).
• The enhanced cytotoxicity was dose‑dependent for both agents and suggests a strong additive effect that could improve outcomes for patients with BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC) CIS.
• The company plans to evaluate this combination in an upcoming clinical trial enrolling patients with high‑risk BCG‑unresponsive NMIBC CIS, with or without resected papillary disease.

Key Details

• Study Design: In vitro assay using T24 human bladder cancer cells; treatments included light‑activated Ruvidar® alone, rhIFNα2b alone, and the combination of both after green‑light activation.
• Results – Ruvidar® Alone: Demonstrated dose‑dependent cytotoxicity (LD30/LD50 metrics reported).
• Results – rhIFNα2b Alone: Also showed dose‑dependent cytotoxicity in T24 cells.
• Combination Effect: Total cell kill increased by 50 % to 65 % compared with Ruvidar® alone, across increasing concentrations of rhIFNα2b.
• Mechanistic Insight: Light‑activated Ruvidar® induces immunogenic tumor cell death, releasing signals that activate innate and adaptive immunity; interferon alpha‑2b adds anti‑proliferative and immune‑stimulating effects.
• Clinical Implication: The additive preclinical effect supports a rationale for a combinational clinical study targeting BCG‑unresponsive NMIBC CIS patients (±Ta/T1).
• Planned Clinical Study: Will enroll and treat patients diagnosed with BCG‑unresponsive NMIBC CIS, with or without resected papillary disease. Specific trial design, enrollment numbers, and timelines were not disclosed.
• Quotes:
• Mark Roufaiel, PhD: “These findings provide mechanistic support for our combinational clinical study… the enhanced total cell kill observed in vitro supports the potential of this complementary approach.”
• Arkady Mandel, MD, PhD, DSc: “Our preclinical research demonstrates that light‑activated Ruvidar® combined with interferon may provide significant benefit to patients afflicted with high‑risk BCG‑unresponsive NMIBC CIS.”
• Roger DuMoulin‑White, President & CEO: “Our preclinical research has been used successfully to support design and development of our clinical programs… I look forward to reviewing the clinical data from the upcoming combinational clinical study.”

Notable Quotes

• “The enhanced total cell kill observed in vitro supports the potential of this complementary approach to improve outcomes for patients with BCG‑unresponsive NMIBC.” – Mark Roufaiel, PhD, Research Scientist
• “I believe that the strong preclinical results demonstrated today will be confirmed clinically in the upcoming collaborative clinical study.” – Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer

All forward‑looking statements are subject to risks and uncertainties as described in the release.