Abstract Describing Significant Results of Crofelemer for Cancer Therapy-Related Diarrhea in Breast Cancer Patients Accepted for Presentation at San Antonio Breast Cancer Symposium (SABCS)
Jaguar Health (NASDAQ:JAGX) announced that a late-breaking abstract showing significant results for crofelemer in breast cancer patients from the Phase 3 OnTarget trial has been accepted for presentation at the San Antonio Breast Cancer Symposium (SABCS) on December 11, 2024. The analysis focuses on breast cancer patients, who formed the majority of participants in this prophylactic trial studying cancer therapy-related diarrhea in adult patients with solid tumors. A second late-breaking abstract based on the trial's placebo arm data will also be presented. The company plans to use these findings to discuss potential pathways with the FDA for making crofelemer available to breast cancer patients.
Jaguar Health (NASDAQ:JAGX) ha annunciato che un abstract presentato in ritardo, che mostra risultati significativi per il crofelemer nei pazienti con cancro al seno provenienti dallo studio di fase 3 OnTarget, è stato accettato per la presentazione al San Antonio Breast Cancer Symposium (SABCS) l'11 dicembre 2024. L'analisi si concentra sui pazienti con cancro al seno, che hanno formato la maggior parte dei partecipanti a questo studio profilattico, che esamina la diarrea correlata alla terapia oncologica in pazienti adulti con tumori solidi. Sarà presentato anche un secondo abstract in ritardo basato sui dati del braccio placebo dello studio. L'azienda prevede di utilizzare questi risultati per discutere potenziali canali con la FDA per rendere disponibile il crofelemer ai pazienti con cancro al seno.
Jaguar Health (NASDAQ:JAGX) anunció que un resumen en última hora que muestra resultados significativos para el crofelemer en pacientes con cáncer de mama del ensayo fase 3 OnTarget ha sido aceptado para su presentación en el San Antonio Breast Cancer Symposium (SABCS) el 11 de diciembre de 2024. El análisis se centra en pacientes con cáncer de mama, que constituyen la mayoría de los participantes en este ensayo profiláctico que estudia la diarrea relacionada con la terapia del cáncer en pacientes adultos con tumores sólidos. También se presentará un segundo resumen en última hora basado en los datos del brazo placebo del ensayo. La empresa planea utilizar estos hallazgos para discutir posibles vías con la FDA para hacer que el crofelemer esté disponible para pacientes con cáncer de mama.
재규어 헬스 (NASDAQ:JAGX)는 Phase 3 OnTarget 시험에서 유방암 환자를 대상으로 한 크로펠레머의 중요한 결과를 보여주는 늦은 발표 초록이 샌안토니오 유방암 심포지엄 (SABCS)에서 2024년 12월 11일 발표하기로 수락되었다고 발표했습니다. 이 분석은 고형 종양을 가진 성인 환자의 암 치료와 관련된 설사 연구를 다룬 이 예방적 시험에 참여한 환자들 중 대다수를 차지하는 유방암 환자에 초점을 맞추고 있습니다. 시험의 위약 arm 데이터를 기반으로 한 두 번째 늦은 발표 초록도 발표될 예정입니다. 이 회사는 이러한 결과를 바탕으로 유방암 환자에게 크로펠레머를 제공하기 위한 FDA와의 잠재적 경로에 대해 논의할 계획입니다.
Jaguar Health (NASDAQ:JAGX) a annoncé qu'un résumé tardif présentant des résultats significatifs pour le crofelemer chez des patientes atteintes de cancer du sein, issu de l'essai de phase 3 OnTarget, a été accepté pour présentation lors du San Antonio Breast Cancer Symposium (SABCS) le 11 décembre 2024. L'analyse porte sur les patientes atteintes de cancer du sein, qui représentaient la majorité des participants à cet essai prophylactique portant sur la diarrhée liée à la thérapie anticancéreuse chez des patients adultes atteints de tumeurs solides. Un second résumé tardif basé sur les données du groupe placebo de l'essai sera également présenté. L'entreprise prévoit d'utiliser ces découvertes pour discuter des voies potentielles avec la FDA afin de rendre le crofelemer disponible pour les patientes atteintes de cancer du sein.
Jaguar Health (NASDAQ:JAGX) hat angekündigt, dass ein spät eingereichtes Abstract, das bedeutende Ergebnisse für Crofelemer bei Brustkrebspatienten aus der Phase 3 OnTarget-Studie zeigt, zur Präsentation beim San Antonio Breast Cancer Symposium (SABCS) am 11. Dezember 2024 angenommen wurde. Die Analyse konzentriert sich auf Brustkrebspatienten, die die Mehrheit der Teilnehmer dieser prophylaktischen Studie zur Untersuchung der krebstherapiebedingten Durchfälle bei erwachsenen Patienten mit soliden Tumoren bildeten. Ein zweites spät eingereichtes Abstract, das auf den Daten der Placebo-Gruppe der Studie basiert, wird ebenfalls präsentiert. Das Unternehmen plant, diese Ergebnisse zu nutzen, um potenzielle Wege mit der FDA zu besprechen, um Crofelemer Brustkrebspatienten zugänglich zu machen.
- Phase 3 OnTarget trial showed significant results for crofelemer in breast cancer patients
- Abstract accepted for presentation at major industry symposium (SABCS)
- Results will be used to engage with FDA for potential drug approval pathway
- None.
Insights
Analysis of the OnTarget trial's breast cancer subgroup data suggests significant results for crofelemer in managing cancer therapy-related diarrhea (CTD). This represents a potentially meaningful development in supportive care for cancer patients, particularly given that breast cancer patients formed the majority of trial participants. The acceptance of two late-breaking abstracts at SABCS, a prestigious breast cancer symposium, adds credibility to the findings.
The company's strategic approach includes leveraging these results for FDA discussions, which could accelerate crofelemer's path to market for breast cancer patients. The involvement of prominent oncologists and patient advocates on the Scientific Advisory Board strengthens the clinical relevance and patient-centric focus of this development. However, investors should note that while the abstract indicates "significant results," specific efficacy data and detailed trial outcomes are not yet disclosed, making it premature to assess the full commercial potential.
Adult patients with breast cancer are a prespecified subgroup of the recently conducted OnTarget trial evaluating crofelemer for prophylaxis of cancer therapy-related diarrhea (CTD)
A second late-breaking abstract related to the OnTarget trial, based on data from the placebo arm of the study, has also been accepted for a poster presentation at SABCS
SAN FRANCISCO, CA / ACCESSWIRE / November 4, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") family company Napo Pharmaceuticals ("Napo") today announced that the late-breaking abstract about the recently completed analysis of the prespecified subgroup of adult patients with breast cancer from the Phase 3 OnTarget trial, which indicates that crofelemer achieved significant results in this subgroup, has been accepted for a poster presentation on December 11, 2024 at the San Antonio Breast Cancer Symposium (SABCS). 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 are thrilled that this important abstract has been accepted for presentation at SABCS. A full study report on the breast cancer subgroup analysis will be presented at the meeting and is expected to be submitted to a peer-reviewed journal," said Lisa Conte, Jaguar's president and CEO. "The content of the abstract will serve as the cornerstone 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."
The lead author of the abstract, and the National Principal Investigator of the OnTarget trial, is Pablo C. Okhuysen, MD, FACP, FIDSA, Professor, Department of Infectious Diseases, Infection Control and Employee Health at MD Anderson Cancer Center at the University of Texas in Houston. Other key authors of the abstract include Pravin Chaturvedi, PhD, Chair of Napo's Scientific Advisory Board (SAB) and Jaguar's Chief Scientific Officer; Napo SAB member Lee Schwartzberg, M.D., FACP, Chief of Medical Oncology at Renown Health in Reno, Nevada; Napo SAB member Eric Roeland, MD, FAAHPM, FASCO, Associate Professor of Medicine, Division of Hematology/Medical Oncology, School of Medicine, Oregon Health & Science University; Napo SAB member Stacey Tinianov, MPH, a Board Certified Patient Advocate; Napo SAB member Dr. Kelly Shanahan, a former clinician and a metastatic breast cancer patient who is now a full-time independent patient advocate; as well as two key advisors to Napo: Enoch Bortey and James Bolognese.
"It is an exciting time to be a part of the company's SAB," said Dr. Shanahan. "As a cancer patient, having options to manage the side effects of life saving drugs is very important. I believe studying crofelemer for the prophylaxis of CTD is very exciting. We cancer patients don't want to take a medication to deal with a side effect that in turn causes a different side effect."
A second late-breaking abstract related to the OnTarget trial, based on data from the placebo arm of the study, has also been accepted for a poster presentation on December 11, 2024 at SABCS.
In addition to participating in both poster presentations with its SAB 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 at makecancerlessshitty.com and on X, Facebook & Instagram
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that a full study report for the OnTarget breast cancer results will be presented at SABCS 2024 and submitted to a peer-reviewed journal, Jaguar's expectation that the content of the abstract will serve as the cornerstone of the 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.
Contact:
Jaguar-JAGX
SOURCE: Jaguar Health, Inc.
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FAQ
What are the results of Jaguar Health's (JAGX) Phase 3 OnTarget trial for crofelemer in breast cancer patients?
When will JAGX present the OnTarget trial results at the San Antonio Breast Cancer Symposium?
What is the next step for JAGX's crofelemer following the OnTarget trial results?
