Jaguar Health Submits Abstract for First-of-Kind Study Evaluating the Impact of Diarrhea from Cancer Therapies in Breast Cancer Patients Who Received Placebo in its OnTarget Phase 3 Trial
Jaguar Health (NASDAQ:JAGX) has submitted a late-breaking abstract for a first-of-kind study evaluating the impact of diarrhea from cancer therapies in breast cancer patients who received placebo in its OnTarget Phase 3 trial. The study analyzed data from 142 patients with solid tumors, including nearly 75 breast cancer patients receiving targeted therapies with or without standard chemotherapy.
The abstract focuses on the incidence, severity, and management of cancer therapy-related diarrhea (CTD) based on patient-reported outcomes (PROs) collected through digital applications. This marks the first time that the natural history of gastrointestinal symptoms from targeted therapies and/or chemotherapy has been reported directly by patients throughout a CTD study.
Napo Pharmaceuticals, a Jaguar family company, is continuing to analyze data from the OnTarget trial and plans further discussions with the FDA. The study aims to provide insights into cancer therapy dose modifications necessitated by CTD and emphasizes the importance of patient-centric studies in providing appropriate supportive care for adult patients with solid tumors.
Jaguar Health (NASDAQ:JAGX) ha presentato un abstract con scadenza tardiva per uno studio innovativo che valuta l'impatto della diarrea causata dalle terapie oncologiche nei pazienti con cancro al seno che hanno ricevuto un placebo nel suo OnTarget studio di Fase 3. Lo studio ha analizzato i dati di 142 pazienti con tumori solidi, inclusi quasi 75 pazienti con cancro al seno che ricevevano terapie mirate con o senza chemioterapia standard.
L'abstract si concentra su incidenza, gravità e gestione della diarrea correlata alla terapia oncologica (CTD) basata sui risultati riportati dai pazienti (PRO) raccolti attraverso applicazioni digitali. Questo segna la prima volta che la storia naturale dei sintomi gastrointestinali da terapie mirate e/o chemioterapia è stata riportata direttamente dai pazienti durante uno studio sulla CTD.
Napo Pharmaceuticals, una società del gruppo Jaguar, sta continuando ad analizzare i dati del trial OnTarget e prevede ulteriori discussioni con la FDA. Lo studio mira a fornire approfondimenti sulle modifiche della dose delle terapie oncologiche necessitate dalla CTD e sottolinea l'importanza degli studi incentrati sul paziente per fornire un'assistenza di supporto adeguata agli adulti con tumori solidi.
Jaguar Health (NASDAQ:JAGX) ha presentado un resumen de última hora para un estudio pionero que evalúa el impacto de la diarrea debido a las terapias contra el cáncer en pacientes con cáncer de mama que recibieron un placebo en su ensayo OnTarget de Fase 3. El estudio analizó datos de 142 pacientes con tumores sólidos, incluidos casi 75 pacientes con cáncer de mama que recibieron terapias dirigidas con o sin quimioterapia estándar.
El resumen se centra en la incidencia, gravedad y manejo de la diarrea relacionada con la terapia oncológica (CTD) basada en los resultados informados por los pacientes (PRO) recopilados a través de aplicaciones digitales. Esta es la primera vez que la historia natural de los síntomas gastrointestinales derivados de terapias dirigidas y/o quimioterapia ha sido reportada directamente por los pacientes durante un estudio de CTD.
Napo Pharmaceuticals, una empresa de la familia Jaguar, continúa analizando los datos del ensayo OnTarget y planea más discusiones con la FDA. El estudio tiene como objetivo proporcionar información sobre las modificaciones de dosis de la terapia contra el cáncer necesarias debido a la CTD y enfatiza la importancia de los estudios centrados en el paciente para ofrecer el cuidado de apoyo adecuado a los pacientes adultos con tumores sólidos.
재규어 헬스 (NASDAQ:JAGX)는 최신 초록을 제출하여 유방암 환자들이 수신한 위약을 바탕으로 암 치료로 인한 설사의 영향을 평가하는 최초의 연구에 대해 보고했습니다. 이 연구는 표적 치료를 받은 거의 75명의 유방암 환자를 포함하여 142명의 고형 종양 환자 데이터를 분석했습니다.
초록은 환자 보고 결과(PRO)를 통해 수집된 정보를 바탕으로 한 암 치료 관련 설사(CTD)의 발생, 중증도 및 관리에 초점을 맞추고 있습니다. 이는 CTD 연구에서 표적 치료 및/또는 화학요법으로 인한 위장 증상의 자연사가 환자들에 의해 직접 보고된 첫 번째 사례입니다.
재규어 가족 회사인 나포 제약은 OnTarget 시험의 데이터를 계속 분석하고 있으며 FDA와 추가 논의를 계획하고 있습니다. 이 연구는 CTD에 의해 필요로 하는 암 치료 용량 수정에 대한 통찰력을 제공하고, 고형 종양이 있는 성인 환자에게 적절한 지원 치료를 제공하는 데 있어 환자 중심 연구의 중요성을 강조합니다.
Jaguar Health (NASDAQ:JAGX) a soumis un résumé de dernière minute pour une étude novatrice évaluant l'impact de la diarrhée causée par les thérapies contre le cancer chez les patientes atteintes du cancer du sein ayant reçu un placebo dans son essai OnTarget de Phase 3. L'étude a analysé les données de 142 patientes atteintes de tumeurs solides, dont près de 75 ayant reçu des thérapies ciblées avec ou sans chimiothérapie standard.
Le résumé se concentre sur l'incidence, la gravité et la gestion de la diarrhée liée aux thérapies anticancéreuses (CTD) en se basant sur les résultats rapportés par les patientes (PRO) collectés via des applications numériques. C'est la première fois que l'histoire naturelle des symptômes gastro-intestinaux résultant des thérapies ciblées et/ou de la chimiothérapie est directement rapportée par les patientes au cours d'une étude sur la CTD.
Napo Pharmaceuticals, une société de la famille Jaguar, continue d'analyser les données de l'essai OnTarget et prévoit d'autres discussions avec la FDA. L'étude vise à fournir des éclairages sur les modifications de doses thérapeutiques anticancéreuses rendues nécessaires par la CTD et souligne l'importance des études centrées sur les patientes pour offrir des soins de soutien appropriés aux patientes adultes atteintes de tumeurs solides.
Jaguar Health (NASDAQ:JAGX) hat ein spät eingereichtes Abstract für eine bahnbrechende Studie eingereicht, die die Auswirkungen von Diarrhöe durch Krebstherapien bei Brustkrebspatienten bewertet, die in der OnTarget Phase 3 Studie ein Placebo erhielten. Die Studie analysierte Daten von 142 Patienten mit soliden Tumoren, darunter fast 75 Brustkrebspatienten, die zielgerichtete Therapien mit oder ohne Standardchemotherapie erhielten.
Das Abstract konzentriert sich auf die Inzidenz, Schwere und Behandlung von krebsbedingter Diarrhöe (CTD), basierend auf den von den Patienten berichteten Ergebnissen (PRO), die über digitale Anwendungen erhoben wurden. Dies ist das erste Mal, dass die Naturgeschichte von gastrointestinalen Symptomen durch zielgerichtete Therapien und/oder Chemotherapie direkt von den Patienten während einer CTD-Studie berichtet wurde.
Napo Pharmaceuticals, ein Unternehmen aus der Jaguar-Familie, analysiert weiterhin die Daten aus der OnTarget-Studie und plant weitere Gespräche mit der FDA. Ziel der Studie ist es, Einblicke in die notwendigen Modifikationen von Krebstherapie-Dosierungen aufgrund von CTD zu geben und die Bedeutung patientenzentrierter Studien für die angemessene unterstützende Versorgung von erwachsenen Patienten mit soliden Tumoren zu betonen.
- First-of-kind study on cancer therapy-related diarrhea (CTD) in breast cancer patients
- Large sample size of 142 patients with solid tumors, including 75 breast cancer patients
- Use of patient-reported outcomes (PROs) for data collection
- Potential insights into cancer therapy dose modifications due to CTD
- Ongoing analysis of OnTarget trial data with plans for FDA discussions
- Study focuses only on placebo group, not treatment outcomes
- No immediate regulatory or commercial implications mentioned
- Potential delays in product development or approval process
Insights
This abstract submission represents a significant step in understanding cancer therapy-related diarrhea (CTD), particularly in breast cancer patients. The study's focus on patient-reported outcomes (PROs) provides valuable real-world data that could impact treatment protocols and patient care.
Key points of interest:
- The study included 142 patients with solid tumors, with nearly 75 breast cancer patients receiving targeted therapies with or without standard chemotherapy.
- PROs were collected using digital applications, offering a more accurate representation of patient experiences compared to traditional investigator reports.
- The data may provide insights into necessary dose modifications due to CTD, which could influence future treatment strategies.
While this news doesn't directly impact Jaguar Health's financials, it demonstrates the company's commitment to addressing unmet needs in cancer supportive care. The insights gained could potentially lead to improved management of CTD, benefiting both patients and healthcare providers. For investors, this research could position Jaguar Health favorably in the oncology supportive care market, potentially leading to future revenue opportunities if it results in new treatment guidelines or product development.
SAN FRANCISCO, CA / ACCESSWIRE / October 8, 2024 / Jaguar Health, Inc.(NASDAQ:JAGX) ("Jaguar") today announced that a late-breaking abstract evaluating the incidence, severity and management of diarrhea from targeted therapies with or without standard chemotherapy in the cohort of adult patients with breast cancer in the placebo group of the OnTarget phase 3 study recently conducted by Jaguar family company Napo Pharmaceuticals, was submitted by the study's primary investigators to a relevant oncology conference for consideration for a presentation. In this study 142 patients with solid tumors received placebo tablets and nearly 75 of them were patients with breast cancer receiving targeted therapies with or without standard chemotherapy. These findings were collected from patient reported outcomes (PROs) provided by the patients using digital applications for their gastrointestinal signs and symptoms.
Napo is continuing the analysis of data from the OnTarget trial, with plans for further discussions with the FDA. The natural history from the placebo group of patients with breast cancer provides further insights into cancer therapy dose modifications necessitated due to cancer therapy-related diarrhea (CTD).
"To our knowledge, this is the first time that the natural history of gastrointestinal symptoms including diarrhea, abdominal pain and discomfort, urgency and fecal incontinence from targeted therapies and/or chemotherapy have been reported directly by patients either at the time of the events or on a daily or weekly basis throughout the treatment period of a cancer therapy-related diarrhea study," said Lisa Conte, Jaguar's president and CEO. "Real world experience from PRO is different from the incidence of adverse effects reported by investigators in the package inserts. Side effects are never a tolerable toxicity, and we continue to remain focused on patient-centric studies to provide appropriate supportive care for adult patients with solid tumors to allow them to perform activities of daily living."
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 plans for further discussions with the FDA based on the additional analysis of data from the OnTarget trial. 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.
View the original press release on accesswire.com
FAQ
What is the purpose of Jaguar Health's OnTarget Phase 3 trial for JAGX stock?
How many patients were involved in Jaguar Health's OnTarget Phase 3 trial for JAGX?
What makes Jaguar Health's OnTarget Phase 3 trial unique for JAGX investors?
What are the next steps for Jaguar Health (JAGX) following the OnTarget Phase 3 trial?
