• The pharmaceutical company declared the completion of CTN submission to Japanese PMDA for TLX250-CDx.
• It is permitted to conduct Phase trials for renal cancer patients.

Australia based clinical-stage biopharmaceutical firm Telix Pharmaceuticals reportedly announced successful completion of a Clinical Trial Notification submission to the Japanese Pharmaceutical & Medical Devices Agency for TLX250-CDx.

For the uninitiated, Telix Pharmaceuticals Limited, headquartered in Australia is a biopharmaceutical company working towards the development of diagnostic and therapeutic products dependent on radiopharmaceuticals.

Reportedly, the company’s owned subsidiary Telix Japan had submitted the CTN at the July end following a robust consultation process with the PMDA. It has been claimed that the company tried resolving the PMDA’s remaining questions whilst collaborating with the other major shareholders like the Ministry of Health, and Labour and Welfare (MHLW).

As per trusted reports, Telix is now allowed to initiate a study designed to extend the company’s global ZIRCON Phase 3 investigation. It has been claimed that the study would register over 40 renal cancer patients. The phase 2 is expected to grow to a multi-focus study whilst operating under a procedure that is considered to be accurately identical to the ZIRCON investigation.

Speaking on the trial, the President of Telix Japan, Dr. Shintaro Nishimura reportedly stated that the company believes that CTN would wholly transform the face of the Japanese Nuclear Medicine community accounting to its first formal clinical investigation for the zirconium PET imaging in Japan. Additionally, TLX250-CDx offers an incredible potential to offer benefits to the cancer patients which would eventually help make way for impending use of theranostics in the country.

Meanwhile, the CEO of the company, Dr, Christian Behrenbruch cited that Telix has introduced a major amount to effort to accomplish the study and make it function in the states of Japan along with manufacturing the radiopharmaceutical products domestically within confined governing environment. Furthermore, the company is grateful to its clinical and finance partners for their constant support and involvement.

Source credit: https://www.globenewswire.com/news-release/2019/08/30/1908793/0/en/Telix-Pharmaceuticals-to-Launch-Japanese-Renal-Cancer-Imaging-Study.html