The Telix Pharmaceuticals Ltd (ASX: TLX) share price has been a strong performer on Thursday.
In morning trade the clinical-stage biopharmaceutical company's shares are up 3.5% to $1.50.
Why is the Telix Pharmaceuticals share price charging higher?
Investors have been buying Telix's shares on Thursday after the release of an update on its Zirconium Imaging in Renal Cancer Oncology (ZIRCON) study.
According to the release, the US Food and Drug Administration (FDA) has approved the recruitment of American patients for its ZIRCON study. The receipt of the Investigational New Drug (IND) notice of allowance will enable patient recruitment to commence in the United States in 30 days.
ZIRCON is an international Phase III study to evaluate the utility of TLX250-CDx (89Zr-girentuximab) for the imaging of clear cell renal cell cancer (ccRCC) using Positron Emission Tomography.
The study is aiming to recruit approximately 250 patients and is currently recruiting at 19 sites in Australia and Europe. The IND allowance in the United States will add up to six leading cancer centres in the United States.
Management expects the trial to complete its enrolment in the middle of 2020.
Telix's CEO, Dr. Christian Behrenbruch, believes that this development is a major milestone for the company.
He said: "This IND is a major milestone for the company in terms of moving ahead the ZIRCON study as well as engagement with US regulators for a late-stage trial. We are excited to be adding US patients to the study. We'd also like to thank our North American manufacturing and pharmacy partners – Isologic and Cardinal Health – for their support with this submission."
What is TLX250-CDx?
TLX250-CDx is an antibody-based imaging agent for use with Positron Emission Tomography.
It targets a cell surface antigen called Carbonic Anhydrase IX (CAIX). It is expressed on the vast majority of 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, colorectal and lung cancers.
