MAIA Biotechnology (NYSE American: MAIA) has received regulatory approval by the Spanish Agency for Medicines and Medical Devices and Portugal’s National Authority of Medicines and Health Products to begin screening patients for its ongoing pivotal Phase 3 THIO-104 clinical trial in non-small cell lung cancer (NSCLC).
According to MAIA, to date, THIO-104 has enrolled 65 NSCLC patients resistant to chemotherapy and checkpoint inhibitor treatments at 28 clinical sites in six European countries and 10 sites in Taiwan. Among the six European countries, sites in Hungary, Poland, and Turkey are actively enrolling and dosing patients from populations with the highest lung cancer incidence and mortality rates in Europe and globally.
Vlad Vitoc, MD, chairman and CEO of MAIA, commented, “Expanding THIO-104 into Spain and Portugal represents another important step in the execution of our pivotal Phase 3 program. Clinical trial participation can provide patients with access to investigational therapies in markets where access to newly approved lung cancer treatments has historically lagged. By establishing THIO-104 sites in Spain and Portugal, we are broadening access to a potentially important new treatment option for patients with advanced NSCLC who have progressed following standard of care treatments.”
