Telix Pharmaceuticals Ltd (ASX: TLX) shares are falling with the market on Thursday morning.
At the time of writing, the radiopharmaceuticals company's shares are down 0.5% to $11.68.
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What's going on with Telix shares?
The company's shares were under pressure on Wednesday and dropped almost 7%. This appears to have been driven by rumours that were circulating in the market regarding its ProstACT Global Phase 3 study.
This study is testing its lead prostate cancer therapy candidate, TLX591 (lutetium ( 177Lu) rosopatamab tetraxetan), in patients with metastatic castration resistant prostate cancer (mCRPC).
According to an announcement after the market close yesterday, Telix has become aware of "inaccurate information in market circulation" and has decided to respond with an update.
What did Telix announce?
It notes that ProstACT Global is the first phase 3 trial to combine a PSMA-targeted radio antibody-drug conjugate (rADC) therapy administered together with standard of care (abiraterone, enzalutamide, or docetaxel) versus the standard of care alone.
Telix confirmed that it has completed patient enrolment into part 1 of the study, a safety and dosimetry lead-in, in accordance with the study protocol.
This means that preparation is now underway to complete data lock and read-out. This includes data from each of the three cohorts in part 1, including the docetaxel cohort which was the final cohort to complete enrolment.
Management points out that as previously disclosed, data from part 1 will be presented to the United States (U.S) Food and Drug Administration (FDA) to ascertain eligibility for U.S. patients to participate in the part 2 (randomised treatment expansion) portion of the study.
The preliminary results from part 1 of the study will be publicly disclosed at the time of readout and engagement with the FDA.
How are things going?
Telix hasn't provided any data, but it appears to be hinting at positive outcomes.
It notes that in accordance with the study protocol, an independent data monitoring committee (IDMC) has reviewed the available data in part 1 of the study and recommended that the study proceed to part 2.
In light of this, Telix has advanced the study into part 2 in jurisdictions where it has obtained approval from health authorities.
Part 2 has been initiated on the basis that part 1 indicates no unexpected safety or clinical characteristics that differ from prior experience.
Furthermore, part 2 of ProstACT Global has dosed its first patients, and is approved and open for enrolment in Australia, New Zealand and Canada. The study has also received regulatory approval to commence in China, Singapore, Türkiye, the United Kingdom, South Korea and Japan.
Management notes that as part of the further global expansion of the trial, Telix intends to file a clinical trial application (CTA) with the European Medicines Agency (EMA) to enable expansion into EU sites.
