Telix Doses First Patient in Phase 3 BiPASS Trial: PSMA-PET Imaging for Prostate Cancer Diagnosis
Telix Pharmaceuticals (NASDAQ: TLX) has initiated its Phase 3 BiPASS clinical trial by dosing the first patient, aiming to expand indications for Illuccix® and Gozellix® in prostate cancer diagnosis. The study will evaluate if combining MRI and PSMA-PET imaging can improve diagnostic accuracy and potentially help patients avoid unnecessary biopsies.
The trial will enroll 204 patients across Australia and the United States. The study builds upon promising research from PRIMARY and PRIMARY2 studies, which demonstrated benefits of combined imaging approaches. If successful, this could expand Telix's U.S. market for PSMA-PET imaging agents by approximately 800,000 scans, addressing a significant clinical need given that up to 75% of current prostate biopsies are negative.
Telix Pharmaceuticals (NASDAQ: TLX) ha avviato lo studio clinico di Fase 3 BiPASS con la somministrazione al primo paziente, con l’obiettivo di ampliare le indicazioni di Illuccix® e Gozellix® nella diagnosi del cancro alla prostata. Lo studio valuterà se la combinazione di MRI e PSMA-PET possa migliorare l’accuratezza diagnostica e, potenzialmente, ridurre il ricorso a biopsie non necessarie.
Il trial arruolerà 204 pazienti in Australia e negli Stati Uniti. Si basa su risultati promettenti degli studi PRIMARY e PRIMARY2, che hanno mostrato vantaggi nell’approccio combinato di imaging. Se avrà esito positivo, potrebbe ampliare il mercato statunitense di Telix per gli agenti PSMA-PET di circa 800.000 scansioni, rispondendo a un bisogno clinico rilevante considerando che fino al 75% delle biopsie prostatiche attuali risultano negative.
Telix Pharmaceuticals (NASDAQ: TLX) ha iniciado su ensayo clínico de Fase 3 BiPASS al administrar la primera dosis a un paciente, con la intención de ampliar las indicaciones de Illuccix® y Gozellix® en el diagnóstico del cáncer de próstata. El estudio evaluará si la combinación de MRI y PSMA-PET puede mejorar la precisión diagnóstica y, potencialmente, ayudar a evitar biopsias innecesarias.
El ensayo reclutará a 204 pacientes en Australia y Estados Unidos. Se apoya en investigaciones prometedoras de los estudios PRIMARY y PRIMARY2, que demostraron beneficios del enfoque combinado de imagen. Si tiene éxito, podría ampliar el mercado estadounidense de Telix para agentes PSMA-PET en aproximadamente 800.000 exploraciones, cubriendo una necesidad clínica significativa dado que hasta el 75% de las biopsias prostáticas actuales son negativas.
Telix Pharmaceuticals (NASDAQ: TLX)가 첫 환자에게 투약하면서 3상 BiPASS 임상시험을 시작했습니다. 이 연구는 Illuccix®와 Gozellix®의 전립선암 진단 적응증을 확대하는 것을 목표로 합니다. 연구는 MRI와 PSMA-PET 영상의 병합이 진단 정확도를 향상시키고 불필요한 생검을 피하는 데 도움이 되는지 평가합니다.
이 시험은 호주와 미국에서 204명의 환자를 등록할 예정입니다. 연구는 결합 영상 접근의 이점을 보여준 PRIMARY 및 PRIMARY2 연구의 유망한 결과를 기반으로 합니다. 성공할 경우 Telix의 미국 내 PSMA-PET 영상제제 시장을 약 80만 건의 스캔만큼 확대할 수 있으며, 현재 전립선 생검의 최대 75%가 음성이라는 점을 고려할 때 중요한 임상적 필요를 충족할 수 있습니다.
Telix Pharmaceuticals (NASDAQ: TLX) a lancé son essai clinique de phase 3 BiPASS en traitant le premier patient, visant à élargir les indications d'Illuccix® et Gozellix® pour le diagnostic du cancer de la prostate. L'étude évaluera si la combinaison de MRI et PSMA‑PET peut améliorer la précision diagnostique et potentiellement permettre d'éviter des biopsies inutiles.
L'essai recrutera 204 patients en Australie et aux États‑Unis. Il s'appuie sur des recherches prometteuses des études PRIMARY et PRIMARY2, qui ont montré les bénéfices d'approches d'imagerie combinées. En cas de succès, cela pourrait étendre le marché américain de Telix pour les agents PSMA‑PET d'environ 800 000 examens, répondant à un besoin clinique important étant donné que jusqu'à 75 % des biopsies prostatiques actuelles sont négatives.
Telix Pharmaceuticals (NASDAQ: TLX) hat seine Phase‑3‑Studie BiPASS gestartet und den ersten Patienten dosiert, mit dem Ziel, die Indikationen für Illuccix® und Gozellix® bei der Prostatakrebs‑Diagnostik zu erweitern. Die Studie wird untersuchen, ob die Kombination von MRI und PSMA‑PET die diagnostische Genauigkeit verbessert und eventuell unnötige Biopsien vermeiden hilft.
Die Studie wird 204 Patienten in Australien und den USA einschließen. Sie baut auf vielversprechenden Ergebnissen der Studien PRIMARY und PRIMARY2 auf, die Vorteile kombinierter Bildgebungsverfahren zeigten. Bei Erfolg könnte dies Telix' US‑Markt für PSMA‑PET‑Agentien um schätzungsweise 800.000 Scans erweitern und einem erheblichen medizinischen Bedarf entsprechen, da bis zu 75 % der aktuell durchgeführten Prostatabiopsien negativ ausfallen.
- Potential to expand U.S. market by approximately 800,000 scans
- Addresses large market need with 1 million biopsies performed annually in U.S.
- Builds on successful PRIMARY and PRIMARY2 studies showing promising results
- Could improve diagnostic accuracy while reducing unnecessary invasive procedures
- Extended timeline required for Phase 3 completion and potential regulatory approval
- Success depends on demonstrating superior diagnostic accuracy compared to current methods
Insights
Telix's Phase 3 BiPASS trial could transform prostate cancer diagnosis and significantly expand Telix's market opportunity by 800,000 scans annually.
Telix's initiation of the Phase 3 BiPASS trial represents a significant clinical milestone with substantial commercial implications. The study aims to demonstrate that combining MRI and PSMA-PET imaging can effectively diagnose prostate cancer while potentially eliminating the need for invasive biopsies in some patients. This 204-patient trial builds on promising earlier research from the PRIMARY studies.
The potential market impact is substantial. Current prostate diagnosis pathways are problematic - over 1 million biopsies are performed annually in the US with up to 75% negative results, while 25% of patients refuse recommended biopsies due to pain and complications. By addressing these issues, Telix could expand the market for its PSMA-PET imaging agents by approximately 800,000 additional scans in the US alone.
The trial's design as a registration-enabling study indicates Telix's regulatory strategy is focused on adding a new indication to their existing approved products (Illuccix and Gozellix). Success would transform their commercial opportunity from primarily staging known cancer to the much larger initial diagnosis market.
This approach aligns with the growing trend toward non-invasive diagnostic techniques in oncology, potentially positioning Telix to establish a new standard of care in prostate cancer diagnosis while significantly expanding their addressable market.
MELBOURNE, Australia and INDIANAPOLIS, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces it has dosed the first patient in a Phase 3 clinical trial aimed at expanding the indications for Illuccix® and Gozellix® (kits for the preparation of gallium-68 (68Ga) gozetotide injection) to include prostate cancer diagnosis.
BiPASS™ (Biopsy of the Prostate Avoidance Stratification Study1) is the first registration-enabling study to evaluate whether the combination of MRI2 and PSMA-PET3 imaging can improve sensitivity, specificity, and positive and negative predictive values in diagnosing prostate cancer. The aim of the study is to demonstrate that some patients can be effectively stratified to either avoid a biopsy altogether or undergo a single PSMA-PET guided biopsy instead. Telix plans to enrol 204 patients in Australia and the United States (U.S.) for the single arm, multicenter, prospective, open label, longitudinal Phase 3 study.
The first BiPASS™ patient was dosed under the supervision of Principal Investigator Professor Tony Costello AM at the Australian Prostate Centre (APC), and imaged by Professor Rodney Hicks AM, at the Melbourne Theranostic Innovation Centre (MTIC). The first patient biopsy was performed by BiPASS™ Investigator and Clinical Director at APC, Mr. Phil Dundee.
Prof. Costello, Founder and Director, APC said, “Urologists are often faced with the dilemma of whether or not to biopsy. This invasive and often painful procedure carries risks, with many men refusing it altogether. From a clinical perspective, when the biopsy shows low to intermediate risk cancer, it’s unclear whether this represents the true burden of disease or sampling error. Combining MRI and PSMA-PET imaging has the potential to improve both the patient experience and diagnostic accuracy. As such, being part of this study is very important to the APC and our patients.”
Prof. Hicks, Founder, Chair and Chief Medical Officer, MTIC added, “PSMA-PET plus MRI has the potential to fundamentally change prostate cancer diagnosis. Using existing technologies with proven performance in lesion detection at the start of the patient journey could improve the way we stratify patients – safely de-escalating treatment or using a single precision biopsy for diagnosis.”
In the current diagnosis pathway, men with elevated PSA4 values can be recommended for MRIs which are often inconclusive. A prostate template biopsy, which typically involves 12 – 20 needle biopsies, is commonly the next step, even in patients deemed as low risk on MRI. However, this non-specific procedure can still miss significant prostate cancer, and can be painful and subject to complications, with many found to be unnecessary. While more than 1 million biopsies are performed in the U.S. each year, up to
Adding an indication for prostate cancer diagnosis has the potential to significantly expand the U.S. market for Telix’s twin commercial PSMA-PET imaging agents by approximately 800,000 scans7.
BiPASS™ builds on a promising body of research, including the PRIMARY8. and PRIMARY29 studies, which demonstrated the advantages of MRI + PSMA-PET imaging in defining or ruling out prostate cancer, or in recommending participants undergo active surveillance before an invasive biopsy is performed. Professor Louise Emmett, Principal Investigator for PRIMARY, will continue her pioneering work as a BiPASS™ Steering Committee member and an Investigator on the study.
Prof. Emmett, Director of Theranostics and Nuclear Medicine, St Vincent’s Hospital, said, “My colleagues and I have built a significant body of research on the benefits of PSMA-PET and MRI, documented in the PRIMARY studies and we are pleased to see Telix expand on this research with this registration-enabling study. BiPASS™ has the potential to positively impact all men by changing clinical practice and guidelines to facilitate earlier, more accurate prostate cancer diagnosis.”
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).
Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA10.
Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.
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Telix Pharmaceuticals Limited
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Telix Pharmaceuticals Limited
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1 ClinicalTrials.gov ID: NCT07052214.
2 Magnetic resonance imaging.
3 Imaging of prostate-specific membrane antigen with positron emission tomography.
4 Prostate-specific antigen.
5 Vickers et al. J Clin Oncol. 2010.
6 Schaufler C et al. Urologic Oncology: Seminars and Original Investigations. 2022.
7 Based on positive scans for PI-RADS (Prostate Imaging Reporting and Data system) scores 2-4 (NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.2.2025), includes negative scans at a ratio of 3.1 scans per positive case (Landa et al. PLOS ONE. 2024).
8 Emmett et al., Eur Urol. 2021.
9 ClinicalTrials.gov ID: NCT05154162. Sponsor: Peter MacCallum Cancer Centre, Australia.
10 Telix ASX disclosure 21 March 2025.
FAQ
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