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
Rhea-AI Summary
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.
Positive
- 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
Negative
- Study focuses only on placebo group, not treatment outcomes
- No immediate regulatory or commercial implications mentioned
- Potential delays in product development or approval process
News Market Reaction 1 Alert
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Data tracked by StockTitan Argus on the day of publication.
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
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