Recruitment For Phase 3 Trial In Renal Cancer: Telix Pharmaceuticals

  • Oct 23, 2018 AEDT
  • Team Kalkine
Recruitment For Phase 3 Trial In Renal Cancer: Telix Pharmaceuticals

Telix Pharmaceuticals (ASX: TLX) is currently developing a range of therapeutic products and diagnostic for renal cell carcinoma sufferers. For its zirconium imaging in renal cancer oncology phase 3 trial, it is preparing to commence recruitment for imaging of clear cell renal cell cancer with one of the company’s leading therapeutic drugs 89Zr-girentuximab.

As both a therapeutic drug and a diagnostic PET imaging agent, TLX250 is being developed denoted as TLX250-CDx. What’s known as carbonic anhydrase IX, TLX250 is an antibody-based platform that targets it a cell surface target that is over-expressed in several serious cancers including: colorectal, renal, lung and oesophagal.

Telix has prioritized the development of TLX250 for metastatic renal cell cancer, at the current time particularly the clear cell variant which almost universally over-expresses CAIX. Otherwise known as “molecularly-targeted radiation” Telix is currently developing a range of diagnostic and therapeutic products based on targeted “radiopharmaceuticals”. 

The company wants to potentially generate commercial marketability in the foreseeable future and leverage the ZIRCON study to advance its development. With at least 15 sites in the US, Europe and Australia, Zircon is a global multi-center phase 3 study. Although to conduct further clinical trials Telix must still seek regulatory approval.

ZIRCON is a prospective imaging trial to detect clear cell renal cell cancer in comparison with histologic ground truth determined, in approximately 250 renal cancer patients undergoing kidney surgery, from surgical resection specimens, will determine the specificity and sensitivity of TLX250-CDx PET imaging.

Ranging from patients with an incidental discovery in the kidney, to diagnosed patients undergoing staging, and for treatment response assessment, the opportunity for advanced renal cancer imaging techniques consists of several distinct clinical needs.

After completing a Clinical Trial Notification submission to the Therapeutic Goods Administration, the company is now preparing to recruit patients at a total of four clinical sites in Australia, according to Telix.

An imaging technique that could help improve conventional techniques, Telix is advancing a potential breakthrough. Kidney cancer patients do not typically image well using existing techniques and are commonly mis-staged as metastases may be very small.

There are roughly 120,000 new diagnoses each year, in the US and the EU, where more precise diagnostic imaging tools would significantly impact patient care. The prevalence of ccRCC is approximately 450,000 patients (SEER) in the US alone, a large proportion, of which should benefit from better imaging for treatment and staging response.

Before the end of this year due to its EU regulatory submissions, Mr. Behrenbruch chief executive officer of Telix has also confirmed that Telix plans to bring online additional international sites with several key review milestones in November on the horizon.


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