Poster Presentation Describing the Significant Results of Crofelemer for Cancer Therapy-Related Diarrhea (CTD) in Breast Cancer Patients to Take Place December 11, 2024 at San Antonio Breast Cancer Symposium (SABCS)
Jaguar Health (NASDAQ:JAGX) announced that data from their Phase 3 OnTarget trial's breast cancer subgroup analysis will be presented at the San Antonio Breast Cancer Symposium (SABCS) on December 11, 2024. The presentation will highlight significant results of crofelemer for Cancer Therapy-Related Diarrhea (CTD) in breast cancer patients, who formed the majority of trial participants.
While the initial OnTarget study did not meet its primary endpoint across all tumor types, the breast cancer subgroup showed promising outcomes. The company plans to submit these findings to the FDA to discuss potential pathways for making crofelemer available to breast cancer patients. A full study report will be submitted to a peer-reviewed journal.
A second poster presentation focusing on the trial's placebo arm data will also be featured at SABCS, which expects over 10,000 attendees.
Jaguar Health (NASDAQ:JAGX) ha annunciato che i dati dell'analisi del sottogruppo di carcinoma mammario dello studio di Fase 3 OnTarget saranno presentati al San Antonio Breast Cancer Symposium (SABCS) l'11 dicembre 2024. La presentazione metterà in evidenza risultati significativi di crofelemer per la diarrea correlata alla terapia oncologica (CTD) in pazienti con cancro al seno, che hanno costituito la maggior parte dei partecipanti allo studio.
Sebbene il primo studio OnTarget non abbia raggiunto il suo obiettivo primario per tutti i tipi di tumori, il sottogruppo di carcinoma mammario ha mostrato risultati promettenti. L'azienda prevede di presentare questi risultati alla FDA per discutere possibili vie per rendere disponibile crofelemer ai pazienti con cancro al seno. Un rapporto completo dello studio sarà inviato a una rivista sottoposta a revisione paritaria.
Una seconda presentazione poster incentrata sui dati del braccio placebo dello studio sarà anche presentata al SABCS, che prevede oltre 10.000 partecipanti.
Jaguar Health (NASDAQ:JAGX) anunció que los datos del análisis del subgrupo de cáncer de mama del ensayo de Fase 3 OnTarget se presentarán en el Simposio sobre Cáncer de Mama de San Antonio (SABCS) el 11 de diciembre de 2024. La presentación destacará resultados significativos de crofelemer para la diarrea relacionada con la terapia del cáncer (CTD) en pacientes con cáncer de mama, quienes formaron la mayoría de los participantes en el ensayo.
Si bien el estudio inicial OnTarget no cumplió con su objetivo primario en todos los tipos de tumores, el subgrupo de cáncer de mama mostró resultados prometedores. La empresa planea enviar estos hallazgos a la FDA para discutir posibles vías para hacer disponible crofelemer a los pacientes con cáncer de mama. Un informe completo del estudio será enviado a una revista revisada por pares.
Una segunda presentación de póster centrada en los datos del brazo placebo del ensayo también se presentará en el SABCS, que espera más de 10,000 asistentes.
재규어 헬스(NASDAQ:JAGX)는 2024년 12월 11일 샌안토니오 유방암 심포지엄(SABCS)에서 3상 OnTarget 시험의 유방암 하위 그룹 분석 데이터가 발표될 것이라고 발표했습니다. 발표는 유방암 환자들, 이들이 시험 참가자의 대다수를 차지한 가운데, 크로펠레머의 중요한 결과를 강조할 것입니다.
초기 OnTarget 연구가 모든 종양 유형에 대해 주요 목표를 달성하지 못했지만, 유방암 하위 그룹은 유망한 성과를 보였습니다. 회사는 유방암 환자에게 크로펠레머를 제공하는 데 대한 잠재적 경로를 논의하기 위해 이러한 발견을 FDA에 제출할 계획입니다. 전체 연구 보고서는 동료 검토 저널에 제출될 것입니다.
시험의 위약 그룹 데이터를 중심으로 한 두 번째 포스터 발표도 SABCS에서 진행될 예정이며, 이는 10,000명이 넘는 참석자를 예상하고 있습니다.
Jaguar Health (NASDAQ:JAGX) a annoncé que les données de l'analyse du sous-groupe de cancer du sein de l'essai de Phase 3 OnTarget seront présentées au San Antonio Breast Cancer Symposium (SABCS) le 11 décembre 2024. La présentation mettra en avant des résultats significatifs de crofelemer pour la diarrhée liée à la thérapie anticancéreuse (CTD) chez les patientes atteintes de cancer du sein, qui ont constitué la majorité des participants à l'essai.
Bien que l'étude OnTarget initiale n'ait pas atteint son objectif principal pour tous les types de tumeurs, le sous-groupe de cancer du sein a montré des résultats prometteurs. L'entreprise prévoit de soumettre ces résultats à la FDA pour discuter des voies potentielles permettant de rendre le crofelemer disponible pour les patientes atteintes de cancer du sein. Un rapport complet de l'étude sera soumis à une revue par les pairs.
Une deuxième présentation d'affiche axée sur les données du bras placebo de l'essai sera également présentée lors du SABCS, qui attend plus de 10 000 participants.
Jaguar Health (NASDAQ:JAGX) gab bekannt, dass Daten aus der Subgruppenanalyse von Brustkrebs der Phase-3-OnTarget-Studie am San Antonio Breast Cancer Symposium (SABCS) am 11. Dezember 2024 präsentiert werden. Die Präsentation wird signifikante Ergebnisse von Crofelemer zur behandlungsbedingten Diarrhoe (CTD) bei Brustkrebspatienten hervorheben, die die Mehrheit der Studienteilnehmer ausmachten.
Obwohl die ursprüngliche OnTarget-Studie ihren primären Endpunkt bei allen Tumorarten nicht erreichte, zeigte die Brustkrebs-Subgruppe vielversprechende Ergebnisse. Das Unternehmen plant, diese Ergebnisse der FDA vorzulegen, um mögliche Wege zu erörtern, wie Crofelemer für Brustkrebspatienten verfügbar gemacht werden kann. Ein vollständiger Studienbericht wird einer Fachzeitschrift zur Begutachtung eingereicht.
Eine zweite Posterpräsentation, die sich auf die Daten der Placebo-Gruppe der Studie konzentriert, wird ebenfalls auf dem SABCS vorgestellt, das über 10.000 Teilnehmer erwartet.
- Significant positive results achieved in breast cancer patient subgroup analysis
- Plans to pursue FDA pathway for crofelemer in breast cancer patients
- Study findings to be submitted to peer-reviewed journal
- OnTarget study failed to meet primary endpoint across all tumor types
Adult patients with breast cancer are a prespecified subgroup of the recently conducted OnTarget trial evaluating crofelemer for prophylaxis of CTD
SAN FRANCISCO, CA / ACCESSWIRE / December 9, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that the data from the recently conducted analysis of the prespecified subgroup of adult patients with breast cancer from the Phase 3 OnTarget trial, which indicate that crofelemer achieved significant results in this subgroup, will be the subject of a poster presentation on December 11, 2024 during the 12:30 - 2:00 p.m. CST Poster Session 1 at the San Antonio Breast Cancer Symposium (SABCS), which takes place December 10-13, 2024 in San Antonio, Texas. Patients with breast cancer accounted for the majority of participants in this unprecedented prophylactic clinical trial recently conducted by Napo for diarrhea in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy.
"We look forward to this presentation at SABCS. A full study report on the breast cancer subgroup analysis is expected to be submitted to a peer-reviewed journal," said Lisa Conte, Jaguar's president and CEO. "The content of the presentation will serve as the basis of the briefing package we plan to submit to the U.S. Food and Drug Administration to request a meeting to discuss possible pathways to make crofelemer available as efficiently as possible to breast cancer patients. Additional analyses of OnTarget prespecified subgroups are ongoing, and we believe data from additional analyses may result in future submissions to peer-reviewed forums."
As previously announced, the initial top line results from the OnTarget study showed that the multicenter, double-blind, placebo-controlled pivotal clinical trial did not meet its primary estimand for the prespecified analysis of all tumor types. The subgroup analysis in adult breast cancer patients indicates that crofelemer achieved significant results in this subgroup.
A second poster presentation related to the OnTarget trial, based on data from the placebo arm of the study, will also take place during Poster Session 1 at SABCS on December 11, 2024.
In addition to participating in both poster presentations with its Scientific Advisory Board members at SABCS, and in alignment with Jaguar's core focus on patient comfort, dignity, and cancer supportive care in general, Napo will be hosting a gathering for patient advocates during SABCS as part of the company's ongoing patient engagement program.
Since 1977, SABCS has been the leading scientific conference for scientists, physicians, clinical investigators, breast care providers, and advocates seeking an exchange of new information in experimental biology, etiology, prevention, diagnosis, and therapy of premalignant breast disease and breast cancer. Based on attendance levels from 2023 SABCS, the symposium organizers anticipate more than 10,000 attendees for this year's event.
About the Jaguar Health Family of Companies
Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.
For more information about:
Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Magdalena Biosciences, visit magdalenabiosciences.com
Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that two poster presentations related to the OnTarget trial will take place at SABCS 2024, Jaguar's expectation that a full study report for the OnTarget results in breast cancer patients will be submitted to a peer-reviewed journal, Jaguar's expectation that the content of the presentation on the OnTarget results in breast cancer patients will serve as the basis of a briefing package the company will submit to the U.S. Food and Drug Administration to request a meeting to discuss possible pathways to make crofelemer available as efficiently as possible to breast cancer patients, Jaguar's expectation that data from additional analyses of OnTarget prespecified subgroups may result in future submissions to peer-reviewed forums, and the expectation that Napo will host a gathering for patient advocates during SABCS as part of the company's ongoing patient engagement program. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Source: Jaguar Health, Inc.
Contact:
Jaguar-JAGX
SOURCE: Jaguar Health, Inc.
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FAQ
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