Telix doses first patient under prostate cancer therapy study
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The news: Telix Pharmaceuticals has dosed its first patient for the second part of a global study to evaluate the lead prostate cancer therapy candidate TLX591 for patients with metastatic castration resistant prostate cancer.
The numbers: Telix will enrol about 490 patients for the study and is currently recruiting patients from Australia, New Zealand and Canada.
The context: The first patient was dosed at the Australian Prostate Centre in Melbourne and is part of the randomised treatment expansion (part 2) of its ProstACT Global Phase 3 study.
Approvals have also been received for China, Japan, Singapore, South Korea, Turkey and the UK.
Data gathered under part 1 of the trial will be submitted to the US Food and Drug Administration (FDA) to receive for part 2 to include patients at US locations. Telix will also file a clinical trial application with the European Medicines Agency (EMA) to include European Union locations in the trial.
What they said: “Dosing the first patient into Part 2 of the randomised treatment expansion of ProstACT Global trial is a significant milestone for Telix’s late-stage prostate cancer therapeutics pipeline,” Telix group chief medical officer David Cade said.
“We look forward to presenting the preliminary data from part 1 of the study to the FDA and EMA in the coming months.”
The source: ASX
