Protara Therapeutics to Present Interim Analysis from the Phase 2 ADVANCED-2 Trial of TARA-002 in Patients with NMIBC at the American Urological Association Annual Meeting
Protara Therapeutics (Nasdaq: TARA) announced upcoming presentations of interim analysis from their Phase 2 ADVANCED-2 trial of TARA-002 at the American Urological Association Annual Meeting in Las Vegas (April 26-29, 2025). The trial focuses on treating non-muscle invasive bladder cancer (NMIBC) patients.
The ADVANCED-2 trial (NCT05951179) is an open-label study evaluating intravesical TARA-002 in two patient groups: BCG-unresponsive (n≈100) and BCG-Naïve (n=30) with carcinoma in situ (CIS). The BCG-Unresponsive cohort is designed to be registrational in alignment with FDA's 2024 guidance.
Updated safety and efficacy data, including 12-month evaluation timepoint results, will be presented during an interactive poster session. The event will feature two presentations and a panel discussion with leading urologists and researchers.
Protara Therapeutics (Nasdaq: TARA) ha annunciato le prossime presentazioni dell'analisi intermedia del loro studio di Fase 2 ADVANCED-2 su TARA-002 durante l'American Urological Association Annual Meeting a Las Vegas (26-29 aprile 2025). Lo studio si concentra sul trattamento dei pazienti con carcinoma vescicale non muscolo invasivo (NMIBC).
Lo studio ADVANCED-2 (NCT05951179) è uno studio aperto che valuta TARA-002 intravesicale in due gruppi di pazienti: BCG-non responsivi (n≈100) e BCG-Naïve (n=30) con carcinoma in situ (CIS). Il coorte BCG-Non Responsivi è progettato per essere registrato in conformità con le linee guida FDA del 2024.
I dati aggiornati di sicurezza ed efficacia, inclusi i risultati del punto di valutazione a 12 mesi, saranno presentati durante una sessione interattiva di poster. L'evento presenterà due presentazioni e una discussione di panel con i principali urologi e ricercatori.
Protara Therapeutics (Nasdaq: TARA) anunció las próximas presentaciones del análisis intermedio de su ensayo de Fase 2 ADVANCED-2 sobre TARA-002 en la reunión anual de la American Urological Association en Las Vegas (26-29 de abril de 2025). El ensayo se centra en el tratamiento de pacientes con cáncer de vejiga no músculo invasivo (NMIBC).
El ensayo ADVANCED-2 (NCT05951179) es un estudio abierto que evalúa TARA-002 intravesical en dos grupos de pacientes: BCG-no responsivos (n≈100) y BCG-naïve (n=30) con carcinoma in situ (CIS). La cohorte BCG-No Responsiva está diseñada para ser registral de acuerdo con las directrices de la FDA de 2024.
Los datos actualizados de seguridad y eficacia, incluidos los resultados del punto de evaluación a 12 meses, se presentarán durante una sesión interactiva de póster. El evento contará con dos presentaciones y una discusión en panel con destacados urólogos e investigadores.
Protara Therapeutics (Nasdaq: TARA)는 라스베가스에서 열리는 미국 비뇨기과학회 연례 회의(2025년 4월 26-29일)에서 TARA-002의 2상 ADVANCED-2 시험의 중간 분석 발표를 예고했습니다. 이 시험은 비근육 침윤성 방광암(NMIBC) 환자 치료에 초점을 맞추고 있습니다.
ADVANCED-2 시험(NCT05951179)은 두 환자 그룹에서 TARA-002의 방광 내 투여를 평가하는 공개 연구입니다: BCG 비반응군(n≈100)과 BCG 초치료군(n=30)으로, 이들은 모두 제자리암(CIS)을 가지고 있습니다. BCG 비반응군은 2024년 FDA의 지침에 따라 등록을 목표로 하고 있습니다.
12개월 평가 시점 결과를 포함한 업데이트된 안전성과 효과 데이터는 인터랙티브 포스터 세션에서 발표될 예정입니다. 이 행사에서는 두 가지 발표와 주요 비뇨기과 의사 및 연구자들과의 패널 토론이 진행될 것입니다.
Protara Therapeutics (Nasdaq: TARA) a annoncé les prochaines présentations de l'analyse intermédiaire de leur essai de phase 2 ADVANCED-2 sur TARA-002 lors de la réunion annuelle de l'American Urological Association à Las Vegas (du 26 au 29 avril 2025). L'essai se concentre sur le traitement des patients atteints de cancer de la vessie non invasif musculaire (NMIBC).
L'essai ADVANCED-2 (NCT05951179) est une étude ouverte évaluant TARA-002 intravésical dans deux groupes de patients : BCG-non répondeurs (n≈100) et BCG-naïfs (n=30) avec carcinome in situ (CIS). La cohorte BCG-Non Répondeur est conçue pour être enregistrable conformément aux directives de la FDA de 2024.
Des données actualisées sur la sécurité et l'efficacité, y compris les résultats du point d'évaluation à 12 mois, seront présentées lors d'une session de poster interactive. L'événement comprendra deux présentations et une discussion en panel avec des urologues et des chercheurs de premier plan.
Protara Therapeutics (Nasdaq: TARA) hat die bevorstehenden Präsentationen der Zwischenanalyse ihrer Phase-2-Studie ADVANCED-2 zu TARA-002 auf dem Jahrestreffen der American Urological Association in Las Vegas (26.-29. April 2025) angekündigt. Die Studie konzentriert sich auf die Behandlung von Patienten mit nicht-muskelinvasivem Blasenkarzinom (NMIBC).
Die ADVANCED-2-Studie (NCT05951179) ist eine offene Studie, die TARA-002 intravesikal in zwei Patientengruppen bewertet: BCG-unresponsive (n≈100) und BCG-naïve (n=30) mit Carcinoma in situ (CIS). Die BCG-unresponsive Kohorte ist darauf ausgelegt, registrierungsfähig zu sein, entsprechend den FDA-Richtlinien von 2024.
Aktualisierte Sicherheits- und Wirksamkeitsdaten, einschließlich der Ergebnisse des 12-Monats-Bewertungspunktes, werden während einer interaktiven Postersitzung präsentiert. Die Veranstaltung umfasst zwei Präsentationen und eine Podiumsdiskussion mit führenden Urologen und Forschern.
- Phase 2 trial designed to be registrational for BCG-Unresponsive cohort
- Trial aligned with latest FDA 2024 guidance
- Large patient enrollment (n≈130 total)
- None.
NEW YORK, April 10, 2025 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that two presentations and a panel discussion highlighting the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC) will be featured at the upcoming American Urological Association (AUA) 2025 Annual Meeting taking place from April 26, 2025 to April 29, 2025 in Las Vegas.
A copy of the abstract for the ADVANCED-2 interim analysis is now available on the AUA website. Updated safety and efficacy data, including data from patients who have reached the 12-month evaluation timepoint, will be featured during an interactive poster session on Saturday, April 26, 2025.
ADVANCED-2 (NCT05951179) is a Phase 2 open-label trial assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-unresponsive (n≈100) and BCG-Naïve (n=30). The BCG-Unresponsive cohort has been designed to be registrational in alignment with the U.S. Food and Drug Administration’s 2024 BCG-Unresponsive Non-muscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment, Draft Guidance for Industry.
Presentation Details:
- Title: Preliminary Anti-Tumor Activity and Safety Results from ADVANCED-2: A Phase 2 Open-Label Study of Intravesical TARA-002 in Adults with High-Grade Non-Muscle Invasive Bladder Cancer
- Session: Bladder Cancer: Non-Invasive I
- Presenter: Gautam Jayram, M.D., Director, Advanced Therapeutics Center, Urology Associates P.C., Nashville, TN
- Session Date and Time: Saturday, April 26, 2025, 7:00 a.m. – 9:00 a.m. PT
- Location: Marco Polo 701
- Title: ADVANCED-2: A Phase 2 Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults with High-Grade Non-Muscle Invasive Bladder Cancer
- Session: Clinical Trials in Progress: Bladder Cancer
- Presenter: Brian Mazzarella, M.D., Vice President of Research at Urology America, Austin, TX
- Session Date and Time: Monday, April 28, 2025, 9:16 a.m. – 9:24 a.m. PT
- Location: Hall C, The Square, Learning Lab
AUA Learning Lab Featured Trials Panel Discussion Details:
- Title: ADVANCED-2: A Phase 2 Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults with High-Grade Non-Muscle Invasive Bladder Cancer
- Moderator: Jacqueline Zummo, Ph.D., Co-Founder, Senior Vice President, Chief Scientific Operations Officer, Protara Therapeutics
- Speakers:
- Timothy D. Lyon, M.D., Associate Professor of Urology and Urology Residency Program Director at Mayo Clinic, Jacksonville, FL
- Brian Mazzarella, M.D., Vice President of Research at Urology America, Austin, TX
- Alex Sankin, M.D., MS, Director of Clinical Trials Program, Associate Program Director of Urology Residency, Associate Professor and Attending Physician at Montefiore Medical Center, Bronx, NY
- Date and Time: Monday, April 28, 2025, 11:00 a.m. – 11:30 a.m. PT
About TARA-002
TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil® in Japan by Chugai Pharmaceutical Co., Ltd and also approved in Taiwan. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.
When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma IL-6, IL-10, IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately
About Protara Therapeutics, Inc.
Protara is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral nutrition who are otherwise unable to meet their choline needs via oral or enteral routes. For more information, visit www.protaratx.com.
Company Contact:
Justine O'Malley
Protara Therapeutics
Justine.OMalley@protaratx.com
646-817-2836
FAQ
What is the primary focus of TARA-002's ADVANCED-2 Phase 2 trial?
How many patients are enrolled in TARA's ADVANCED-2 trial?
When will TARA present the ADVANCED-2 trial interim results?
Is TARA's ADVANCED-2 trial aligned with FDA guidelines?
