- Telix Pharmaceuticals (TLX) has received approval from the U.S. Food and Drug Administration for the ZIRCON study
- The ZIRCON study is an international Phase III study to evaluate the utility of Telix’s product which treats clear cell renal cancer
- Receipt of an Investigational New Drug notice of allowance will enable patient recruitment to begin in the U.S. in 30 days
- Telix has ended the day up 3.45 per cent with shares trading for $1.50 each
Telix Pharmaceuticals (TLX) has received approval from the U.S. Food and Drug Administration (FDA) for the ZIRCON study.
This approval comes almost a month after the company submitted a clinical briefing package to the FDA and submitted the application.
Receipt of an Investigational New Drug (IND) notice of allowance will enable patient recruitment to begin in the United States in 30 days.
The ZIRCON (Zirconium Imaging in Renal Cancer Oncology) is an international Phase III study to evaluate the utility of TLX250-CDx for the imaging of clear cell renal cell cancer (ccRCC) using Position Emission Tomography (PET).
TLX250-CDx is used for the imaging of renal cell cancer and it targets a cell-surface antigen called Carbonic Anhydrase IX (CAIX), a target that is over-expressed in ccRCC.
Many patients with renal cancer are diagnosed with an indeterminate (unspecified) renal mass through routine imaging procedures and TLX250-CDx is able to determine whether the findings are cancerous or not.
Additionally, it is sensitive metastatic disease and is potentially enormously beneficial to correctly staging patients with ccRCC.
In 2018 more than 400,000 people worldwide were diagnosed with kidney cancer and more than 175,000 died from it.
Kidney cancer is about twice as common in men than in women and is increased by smoking, obesity diabetes, and high blood pressure.
While there are different types, Telix is focused on ccRCC which has a high risk of metastasis (spreading to other sites in the body).
The study aims to recruit approximately 250 patients and it is currently recruiting at 19 sites in Australia and Europe and the IND allowance in the U.S. will add up to a further six leading cancer centres in the states.
The trial is expected to complete enrolment in the mid-year.
“This IND is a major milestone for the company in terms of moving ahead the ZIRCON study as well as engagement with U.S. regulators for a late-stage trial,” Telix CEO Dr Christian Behrenbruch stated.
“We’d also like to thanks our North American manufacturing and pharmacy partners – Isologic and Cardinal Health – for their support with this submission,” he added.
Telix has ended the day up 3.45 per cent with shares trading for $1.50 in a $379.9 million market cap.