- Telix Pharmaceuticals (TLX) has submitted a phase 3 Investigational New Drug application to the U.S. FDA for its antibody-based imaging agent
- This applications forms part of the international phase 3 ZIRCON study which is expected to begin enrolling U.S. patients in Q1 2020
- A total of 19 sites in Europe and Australia are currently enrolling patients in the study with the planned addition of 6 U.S. cancer centres will enable the study to be fully recruited by the first half of 2020
- Telix has entered the two day break up 6.98 per cent with shares trading for $1.61 each
Telix Pharmaceuticals (TLX) has submitted a phase 3 Investigational New Drug (IND) application to the U.S. FDA for TLX250-CDx.
TLX250-CDx is an antibody-based imaging agent for use with Positron Emission Tomography (PET).
It targets a cell surface antigen called Carbonic Anhydrase IX (CAIX) which is expressed on the vast majority of clear cell renal cell cancers (ccRCC), which is the most common form of kidney cancer.
CAIX is also highly expressed in many other cancers with poor prognosis such as pancreatic, bladder, lung and colorectal.
In 2018 more than 400,000 people worldwide were diagnosed with kidney cancer and more than 175,000 people died from it.
Kidney cancer is twice as common in men than women and the risk of developing it is increased by smoking, obesity, diabetes, and high blood pressure.
This applications forms part of the international phase 3 ZIRCON study which is expected to begin enrolling U.S. patients in Q1 2020.
“Nineteen sites in Europe and Australia are currently enrolling patients into the ZIRCON study,” Telix CEO Dr. Christian Behrenbruch stated.
“The planned addition of 6 U.S. cancer centres to recruit at least 50 U.S. patients will enable the study to be fully recruited 1H-2020,” he added.
ZIRCON (Zirconium Imaging in Renal Cancer Oncology) is an international, confirmatory phase 3 trial for the imaging of ccRCC using TLX250-CDx with PET.
This trial will recruit approximately 250 patients and compares PET imaging with histology findings from the surgically cut out tumour.
Telix has entered the two day break up 6.98 per cent with shares trading for $1.61 each in a $381.1 million.