Telix Japan is now permitted to commence a Phase I/II trial that is designed to bridge to the Company’s international ZIRCON Phase III study
Image: The study will enrol 40 renal cancer patients. Photo: Courtesy of Darko Stojanovic from Pixabay.
Telix Pharmaceuticals, a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or “molecularly-targeted radiation” (MTR) today announced successful completion of a Clinical Trial Notification (CTN) submission to the Japanese Pharmaceutical and Medical Devices Agency (PMDA) for TLX250-CDx (89Zr-girentuximab).
The Company’s wholly owned subsidiary Telix Pharmaceuticals Japan submitted the CTN at the end of July after an extensive consultation process with the PMDA. The Company has resolved the PMDA’s remaining questions and has also closely engaged with other key stakeholders such as Ministry of Health, Labour and Welfare (MHLW), the Japan Radioisotope Association (JRIA) and clinical key opinion leaders.
Telix Japan is now permitted to commence a Phase I/II trial that is designed to bridge to the Company’s international ZIRCON Phase III study. The study will enrol 40 renal cancer patients. The Phase I portion is a single-site study that will evaluate an initial cohort of patients to confirm that pharmacology/dosimetry is equivalent in Japanese subjects. The Phase II portion will expand to a multi-centre study, operating under a protocol that is effectively identical to the ZIRCON trial.
Telix Pharmaceuticals Japan K.K. President Dr. Shintaro Nishimura, stated, “We believe this CTN is a transformative event for the Japanese Nuclear Medicine community as it is the first formal clinical trial for a zirconium-labeled PET imaging agent in Japan. TLX250-CDx has tremendous potential to deliver benefit to Japanese cancer patients and this accomplishment will help to pave the way for the future use of “theranostics” in Japan.”
Telix CEO Dr. Christian Behrenbruch, added, “It’s been a significant amount of effort to get this study up and running in Japan, particularly as we have also had to manufacture the radiopharmaceutical product locally within a very strict regulatory environment. We are appreciative to our clinical and business partners, particularly JFE Engineering (manufacturing partner) and Nihon Medi-Physics (commercial partner) for their excellent support and engagement.”
Source: Company Press Release