Onconetix Announces New Clinical Data for its Innovative Prostate Cancer Test Proclarix Accepted for Presentation at 2025 European Association of Urology Congress
Onconetix (NASDAQ: ONCO) has announced that new clinical data for its prostate cancer test Proclarix will be presented at the 2025 European Association of Urology (EAU) congress in Madrid, Spain, from March 21-24, 2025.
The presentation, titled 'Clinical Performance of Proclarix in Ruling Out Clinically Insignificant or No Prostate Cancer: Evaluation in a Danish Cohort,' will showcase results from a study involving over 800 patients from Lillebaelt Hospital - University Hospital of Southern Denmark.
According to Ralph Schiess, PhD, CEO of Proteomedix (a wholly-owned subsidiary of Onconetix), Proclarix has demonstrated in multiple studies its ability to reduce performed biopsies by ruling out patients with clinically insignificant or no prostate cancer, while maintaining minimal risk of missing clinically significant cases compared to standard care.
Onconetix (NASDAQ: ONCO) ha annunciato che nuovi dati clinici per il suo test sul cancro alla prostata Proclarix saranno presentati al congresso 2025 della European Association of Urology (EAU) a Madrid, Spagna, dal 21 al 24 marzo 2025.
La presentazione, intitolata 'Performance Clinica di Proclarix nel Riconoscere il Cancro alla Prostata Clinicamente Insignificante o Assente: Valutazione in una Coorte Danese,' mostrerà i risultati di uno studio che ha coinvolto oltre 800 pazienti dell'Ospedale Lillebaelt - Ospedale Universitario della Danimarca Meridionale.
Secondo Ralph Schiess, PhD, CEO di Proteomedix (una controllata interamente di Onconetix), Proclarix ha dimostrato in diversi studi la sua capacità di ridurre le biopsie eseguite escludendo i pazienti con cancro alla prostata clinicamente insignificante o assente, mantenendo al contempo un rischio minimo di perdere casi clinicamente significativi rispetto alle cure standard.
Onconetix (NASDAQ: ONCO) ha anunciado que nuevos datos clínicos para su prueba de cáncer de próstata Proclarix se presentarán en el congreso 2025 de la Asociación Europea de Urología (EAU) en Madrid, España, del 21 al 24 de marzo de 2025.
La presentación, titulada 'Rendimiento Clínico de Proclarix en la Exclusión de Cáncer de Próstata Clínicamente Insignificante o Ausente: Evaluación en una Cohorte Danesa,' mostrará los resultados de un estudio que involucró a más de 800 pacientes del Hospital Lillebaelt - Hospital Universitario de Dinamarca Meridional.
Según Ralph Schiess, PhD, CEO de Proteomedix (una subsidiaria de propiedad total de Onconetix), Proclarix ha demostrado en múltiples estudios su capacidad para reducir las biopsias realizadas al excluir a los pacientes con cáncer de próstata clínicamente insignificante o ausente, manteniendo un riesgo mínimo de perder casos clínicamente significativos en comparación con el tratamiento estándar.
온코네틱스 (NASDAQ: ONCO)는 새로운 전립선암 검사 프로클라릭스에 대한 임상 데이터가 2025년 3월 21일부터 24일까지 스페인 마드리드에서 열리는 2025 유럽 비뇨기학회 (EAU) 총회에서 발표될 것이라고 발표했습니다.
‘임상적으로 중요하지 않거나 전립선암이 없는 경우 프로클라릭스의 임상 성능: 덴마크 코호트 평가’라는 제목의 발표는 덴마크 남부의 리레벨트 병원에서 800명 이상의 환자를 포함한 연구 결과를 보여줄 것입니다.
Proteomedix의 CEO인 Ralph Schiess 박사에 따르면 (온코네틱스의 완전 자회사), 프로클라릭스는 여러 연구에서 임상적으로 중요하지 않거나 전립선암이 없는 환자를 배제하여 수행된 생검을 줄이는 능력을 입증했으며, 표준 치료와 비교하여 임상적으로 중요한 사례를 놓칠 위험을 최소화하고 있습니다.
Onconetix (NASDAQ: ONCO) a annoncé que de nouvelles données cliniques pour son test de cancer de la prostate Proclarix seront présentées lors du congrès 2025 de l'Association Européenne d'Urologie (EAU) à Madrid, en Espagne, du 21 au 24 mars 2025.
La présentation, intitulée 'Performance Clinique de Proclarix dans l'Exclusion du Cancer de la Prostate Cliniquement Insignifiant ou Non Présent : Évaluation dans une Cohorte Danoise,' mettra en avant les résultats d'une étude impliquant plus de 800 patients de l'Hôpital Lillebaelt - Hôpital Universitaire du Danemark Méridional.
Selon Ralph Schiess, PhD, PDG de Proteomedix (une filiale entièrement détenue d'Onconetix), Proclarix a démontré dans plusieurs études sa capacité à réduire le nombre de biopsies réalisées en excluant les patients avec un cancer de la prostate cliniquement insignifiant ou absent, tout en maintenant un risque minimal de manquer des cas cliniquement significatifs par rapport aux soins standards.
Onconetix (NASDAQ: ONCO) hat angekündigt, dass neue klinische Daten für seinen Prostatakrebs-Test Proclarix auf dem 2025 Kongress der European Association of Urology (EAU) in Madrid, Spanien, vom 21. bis 24. März 2025 präsentiert werden.
Die Präsentation mit dem Titel 'Klinische Leistung von Proclarix bei der Ausschlussdiagnose von klinisch unbedeutendem oder nicht vorhandenem Prostatakrebs: Bewertung in einer dänischen Kohorte' wird Ergebnisse einer Studie zeigen, die über 800 Patienten vom Lillebaelt Hospital - Universitätskrankenhaus Süddänemark umfasst.
Laut Ralph Schiess, PhD, CEO von Proteomedix (einer hundertprozentigen Tochtergesellschaft von Onconetix), hat Proclarix in mehreren Studien seine Fähigkeit zur Reduzierung durchgeführter Biopsien unter Beweis gestellt, indem es Patienten mit klinisch unbedeutendem oder nicht vorhandenem Prostatakrebs ausschließt und gleichzeitig das Risiko minimiert, klinisch signifikante Fälle im Vergleich zur Standardversorgung zu übersehen.
- Large-scale validation study with 800+ patients strengthens Proclarix's clinical evidence
- Demonstrated ability to reduce unnecessary biopsies while maintaining accuracy
- International recognition through acceptance at major medical congress
- Actual study results and specific performance metrics not yet disclosed
- No immediate revenue impact mentioned from this development
CINCINNATI, March 19, 2025 (GLOBE NEWSWIRE) -- Onconetix, Inc., (Nasdaq: ONCO) (“Onconetix” or the “Company”), (formerly Blue Water Biotech, Inc. (BWV)), a cancer diagnostics company focused on the research, development and commercialization of innovative solutions for oncology, today announced that an abstract has been accepted for presentation at the 2025 European Association of Urology (EAU) congress taking place March 21-24, 2025, in Madrid, Spain.
The presentation, titled, “Clinical Performance of Proclarix in Ruling Out Clinically Insignificant or No Prostate Cancer: Evaluation in a Danish Cohort,” will highlight Proclarix performance results recently obtained from a study including more than 800 patients recruited from Lillebaelt Hospital - University Hospital of Southern Denmark.
“The abstract accepted for presentation at EAU congress will showcase the importance of early detection of prostate cancer, particularly using Proclarix, a biomarker-based blood test,” stated Ralph Schiess, PhD, CEO of Proteomedix, a wholly-owned subsidiary of Onconetix, and added: “Proclarix has already demonstrated in multiple studies that it can be safely used to reduce performed biopsies by ruling out patients with clinically insignificant or no prostate cancer while minimizing the risk of missing clinically significant cancer when compared to standard of care.”
Details on the presentation are as follows:
| Presentation Title: | Clinical Performance of Proclarix in Ruling Out Clinically Insignificant or No Prostate Cancer: Evaluation in a Danish Cohort |
| Presenter: | Zedan Raid A.H, Lillebaelt Hospital - University Hospital of Southern Denmark, Department of Oncology, Vejle, Denmark |
| Session Title: | Diagnostic and prognostic biomarkers in prostate cancer |
| Date and Time: | March 23, 2025, from 5:15 PM to 6:45 PM CET |
About Proclarix®
Proclarix® is CE-certified under In Vitro Diagnostic Regulation (“IVDR”) and indicated for prostate cancer diagnosis in patients with normal digital rectal exam (DRE), enlarged prostate volume and elevated levels of PSA at 2-10 ng/ml. Proclarix® is a risk score combining in-vitro assays for the quantitative detection of biomarkers with a proprietary algorithm to assess a patient’s risk of having clinically significant prostate cancer. Detection of prostate cancer-related biomarkers in blood serum using the Proclarix® risk score has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of clinically significant prostate cancer. Proclarix® is included in both the European (EAU) and American (AUA) guidelines.
About Onconetix, Inc.
Onconetix is a commercial stage biotechnology company focused on the research, development and commercialization of innovative solutions for men’s health and oncology. Through our recent acquisition of Proteomedix, we own Proclarix®, an in vitro diagnostic test for prostate cancer originally developed by Proteomedix and approved for sale in the European Union (“EU”) under the IVDR, which we anticipate will be marketed in the U.S. as a lab developed test (“LDT”) through our license agreement with Labcorp. We also own ENTADFI, an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia (“BPH”), a disorder of the prostate. For more information, visit www.onconetix.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements (including, without limitation, the anticipated results of the Company’s sales and marketing efforts for its commercial stage products as described herein) are based on Onconetix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, market and other conditions; risks related to Onconetix’s ability to commercialize or monetize Proclarix and integrate the assets and commercial operations acquired in the share exchange with Proteomedix; risks related to the Company’s present need for capital to commercially launch Proclarix and have adequate working capital; risks related to Onconetix’s ability to attract, hire and retain skilled personnel necessary to commercialize and operate the Company’s commercial products; the failure to obtain and maintain the necessary regulatory approvals to market and commercialize Onconetix’s products; risks related to the Company’s ability to obtain and maintain intellectual property protection for its current products; whether the Company will be able to maintain compliance with Nasdaq’s applicable listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; and the Company’s reliance on third parties, including manufacturers and logistics companies. As with any commercial-stage pharmaceutical product or any product candidate under clinical development, there are significant risks in the development, regulatory approval and commercialization of biotechnology products. Onconetix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Onconetix’s Annual Report on Form 10-K, filed with the SEC on April 11, 2024 and periodic reports filed with the SEC on or after the date thereof. All of Onconetix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Investor and Media Contact Information:
Onconetix, Inc.
201 E. Fifth Street, Suite 1900
Cincinnati, OH 45202
Phone: (513) 620-4101
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Email: investors@onconetix.com
FAQ
What are the key findings of Onconetix's (ONCO) Proclarix study being presented at EAU 2025?
How does Proclarix improve prostate cancer detection compared to standard care?
Where and when will ONCO present its new Proclarix clinical data?
How many patients were included in ONCO's Danish Proclarix study?
