Global biopharmaceutical company Telix Pharmaceuticals Limited (ASX: TLX) made an announcement on 19 December 2018 stating that it has completed the first and second stage consultations with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Further, the company has been given permission to submit a final stage application by the 11th January 2019 for a Phase I/II study of 89Zr-girentuximab (TLX250-CDx) in Japan. Following this news, the share price of the company increased by 6.78 percent as on 19 December 2018.
Pharmaceuticals and Medical Devices Agency (PMDA) is involved in the operations of regulating pharmaceutical products in Japan, and for that it is having a three-step consultation process that leads to the submission of a Clinical Trial Notification (CTN) and the approval to commence a clinical trial in Japanese patients. Telix Pharmaceuticals has completed the first two stages of the consultation process and now it has been permitted to prepare for the final formal stage that will lead to the submission of a CTN early next year.
The Phase I/II study of 89Zr-girentuximab (TLX250-CDx) is being conducted to validate the existing US and EU experience of imaging kidney cancer with girentuximab (anti-CAIX antibody) in Japanese patients. The study will be based on the EU experience with TLX250-CDx, particularly the ZIR-DOSE study (EudraCT 2017-004769-2). The trial, which is scheduled to start in the second quarter of 2019 will use a product manufactured in Japan by Telix’s partner JFE Engineering and will bridge to the global ZIRCON Phase III study (EudraCT 2018-002773-21).
As per Telix Pharmaceuticals Japan President Dr. Shintaro Nishimura, in the past six months, the company has made significant progress with TLX250-CDx in Japan, and its preliminary engagement with the PMDA has been very helpful in developing a roadmap for this product in Japan. Dr. Shintaro further added that the imaging of CAIX in Japanese patients has potential utility in a wide variety of cancers, including renal cancer, and the company is very pleased with the progress in both manufacturing and regulator engagement.
On 19 December 2018, the company also announced that it has completed the enrolment for its ZIR-DOSE Clinical Study. The ZIR-DOSE study is a small ten patient study that was run as part of the Company’s development of TLX250-CDx. The ZIR-DOSE trial bridges previous iodine-based imaging experience in kidney cancer to the company’s improved zirconium-based product, confirming significantly improved image quality and radiation characteristics. The final analysis of the ZIR-DOSE study is likely to be completed by the end of the first quarter of 2019, but it is not expected to differ in outcome from the interim results. As per Telix co-founder and CEO Dr. Christian Behrenbruch, ZIR-DOSE clinical study is a very demanding study for patients as it requires a large number of visits from patients and it also requires an extensive amount of imaging time to measure dosimetry.
In the last six months, the share price of the company decreased by 9.23 percent as on 18 December 2018. TLX’s shares traded at $0.630 with a market capitalization of circa $125.24 million as on 19 December 2018 (AEST 4:00 PM).