The Telix Pharmaceuticals Ltd (ASX: TLX) share price is up almost 6% in early trade.
Below, we take a look at the ASX biotechnology company's announcement of its approval to conduct a clinical trial.
What did Telix announce?
The Telix share price is up 5.94% this morning to $6.96 after the company reported positive progress for its investigational kidney cancer therapy, TLX250.
In another step forward for TLX250, the United States Food and Drug Administration (FDA) has accepted the Investigational New Drug Application (IND) to commence a clinical study of the experimental treatment.
Telix expects to enrol 29 patients with advanced clear cell renal cell carcinoma (ccRCC) in its STARLITE 2 study. The goal of the study is to determine the efficacy of combining immunotherapy with TLX250.
Commenting on the study, principal investigator Darren Feldman said:
Each year 76,000 Americans will be diagnosed with kidney cancer, therefore it is important we continue to explore new treatment options. The selective targeting of TLX250 to CA9 delivers radiation therapy directly to ccRCC tumours. Combining this innovative approach with anti-PD-1/PD-L1 therapy could enhance existing immune-based treatments.
Telix chief medical officer Colin Hayward added:
The introduction of immunotherapy agents has improved the outlook for patients with advanced clear cell renal cancer, but most patients eventually progress. This therapy, along with patient selection and treatment response assessment with our CA9-targeting imaging agent TLX250-CDx may potentially offer a new paradigm of more accurate staging and personalised treatment for kidney cancer patients through a "theranostic" approach.
Today's FDA approval comes on the heels of yesterday's announcement revealing that Telix had "entered into an exclusive commercial distribution agreement with Bologna-based Radius" to distribute Illuccix – a cancer imaging tool – in Italy.
Telix share price snapshot
Over the past 12 months the Telix share price has soared 279%, well outpacing the 27% gains posted by the All Ordinaries Index (ASX: XAO).
Telix shares have continued to move higher over the past month, up 21%.
