- Telix Pharmaceuticals (TLX) is set to commence a phase three clinical trial of its targeted therapy candidate TLX591 in prostate cancer patients
- The company was recently approved by the Human Research Ethics Committee and Therapeutic Goods Administration to begin the study
- The 390-patient "ProstACT" trial will target patients with advanced metastatic castrate-resistant prostate cancer
- TLX will test standard-of-care therapy alone versus in combination with its candidate, with a primary endpoint of radiographic progression-free survival
- Telix has started initiating Australian ProstACT trial sites with the view to add global sites progressively during the second half of the year
- Shares are up 4.57 per cent, trading at $4.12 each
Telix Pharmaceuticals (TLX) has been given the green light to commence a phase three clinical trial of its targeted therapy candidate TLX591 in prostate cancer patients.
Headquartered in Melbourne, Telix is a clinical-stage biopharmaceutical company developing a portfolio of products to address significant unmet medical needs in oncology and rare diseases.
The company was recently approved by the Human Research Ethics Committee and Therapeutic Goods Administration to conduct the phase three trial, targeting patients with advanced metastatic castrate-resistant prostate cancer (mCRPC).
The "ProstACT" trial, TLX says, will take the form of an international, multi-centre, randomised controlled trial in patients with prostate-specific membrane antigen-expressing mCRPC.
Further, the company says participating patients will be experiencing disease progression following prior treatment with a novel androgen axis drug.
The 390-patient study will compare standard-of-care therapy alone versus standard-of-care therapy in addition to TLX591, with a primary endpoint of radiographic progression-free survival.
Telix's CEO Dr Christian Behrenbruch said the trial marks a major corporate milestone, brings the company closer to "delivering on a major unmet medical need for treatment options in this patient population."
"ProstACT builds on a significant body of clinical data for TLX591, which to date has been studied in over 200 patients with advanced prostate cancer, across five previous studies," Dr Behrenbruch said.
"TLX has demonstrated promising and competitive clinical potential that we believe warrants further confirmation in this second-line disease setting."
Telix has started initiating Australian ProstACT trial sites with the view to progressively add global sites during the second half of the year, subject to requisite approvals.
On the market this afternoon, Telix Pharmaceuticals shares are up 4.57 per cent, trading at $4.12 each at 2:00 pm AEST.