Napo Pharmaceuticals, a subsidiary of Jaguar Health on target trial adding international sites, targeting enrollment completion in Q2 2023
SAN FRANCISCO, CA/ACCESSWIRE/November 21, 2022/ Jaguar Health, Inc. (NASDAQ: JAGX) and its wholly-owned subsidiary Napo Pharmaceuticals (Napo) announced today that Napo is hosting a hybrid symposium on November 18, 2022 titled Management of diarrhea associated with cancer treatment: is it time for a paradigm shift? The symposium included presentations from leading oncology and infectious disease experts and discussed the impact of cancer treatment-related diarrhea (CTD) as well as the unmet need for the burden of CTD based on the guidelines of current management.
The symposium also discussed the need for diarrhea prophylaxis in cancer patients as a paradigm shift to mitigate the impact of CTD on Activities of Daily Living (ADL), dose reductions cancer treatment and/or interruptions and overall improvement in quality of life. (QOL) of cancer patients receiving targeted therapy with or without standard chemotherapy. In addition, the panel discussed the recently published results of a recent prophylactic study in breast cancer patients receiving trastuzumab, pertuzumab and a taxane with or without crofelemer (HALT-D) and the characteristics from the ongoing pivotal Phase 3 clinical study evaluating the safety and efficacy of crofelemer for TCM prophylaxis in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy (Protocol NP303-102; study OnTarget). The symposium was attended in person by some of the OnTarget study researchers as well as remotely by researchers from various clinical sites inside and outside the United States.
“We were very pleased with the level of participation in this first-ever symposium to discuss the management of CTD and the neglected burden of CTD on cancer patients,” said Pravin Chaturvedi, PhD, Chair of the Scientific Advisory Board. from Napo Pharmaceuticals and Jaguar Health. and scientific director. “We are grateful to the clinical and scientific leaders from the oncology community who joined us to discuss the limitations of CTD management guidelines and the potential impact of crofelemer for CTD prophylaxis. The content of the symposium will provide existing and potential clinical investigators with more information about the value of CTD prophylaxis as being studied in the pivotal OnTarget trial.
Speakers and panelists at the symposium included faculty members from academic institutions and private clinics as well as Napo’s clinical leadership team:
Pablo C. Okhuysen, MD: Professor of Medicine, Department of Infectious Diseases, Infection Control, and Employee Health, Division of Internal Medicine, University of Texas, MD Anderson Cancer Center in Houston, TX.
Lee Schwartzberg, MD, FACP: A leading breast cancer medical oncologist and hematologist who serves as Chief of Medical Oncology and Hematology at Renown Health-William N. Pennington Cancer Institute in Reno, NV; formerly Executive Director, West Clinic, Memphis, TN.
Eric Roeland, MD, FAAHPM: Assistant Professor of Medicine, Division of Hematology/Medical Oncology, School of Medicine, Oregon Health and Science University; formerly Assistant Professor of Medicine, Massachusetts General Hospital, Harvard Medical School.
James T. D’Olimpio, MD, FACP, FAAHPM: Principal Investigator/Consultant, Clinical Research Alliance, Westbury, NY; formerly Director of Supportive Oncology/Cancer Pain and Symptom Management at North Shore University Hospital and Assistant Professor of Medicine at Hofstra/North Shore-LIJ School of Medicine.
Paula Pohlmann, MD, PhD: Associate Professor, MD Anderson Cancer Center.
Pravin Chaturvedi, PhD: Chairman of the Scientific Advisory Board and Chief Scientific Officer of Napo Pharmaceuticals and Jaguar Health.
Darlene Horton, MD: Chief Medical Officer of Napo Pharmaceuticals.
Allison Shrier, MD: Vice President of Clinical Research and Medical Affairs for Napo Pharmaceuticals.
About Diarrhea Related to Cancer Treatment
A significant proportion of patients undergoing cancer treatment experience diarrhea, and diarrhea can lead to dehydration, potential infections, and nonadherence to treatment in this population. Newer “targeted cancer therapy” agents, such as anti-epidermal growth factor receptor (EGFR) antibodies and tyrosine kinase (TKI) inhibitors, with or without cyclic chemotherapy agents, may lead to increased electrolyte and fluid content in the intestinal lumen resulting in the passage of loose/watery stools (i.e. diarrhea). Diarrhea has been reported as one of the most common side effects of TKIs and can lead to cancer treatment interruptions or therapeutic dose reductions, which can impact patient outcomes. Diarrhea is also a common side effect of some approved CDK 4/6 inhibitors.
Crofelemer is a new oral herbal medicine purified from the sap of the red bark, also called “dragon’s blood”, of the medicinal plant Croton lechleri tree in the Amazon rainforest. Napo Pharmaceuticals has implemented a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity and support for indigenous communities.
About Jaguar Health, Napo Pharmaceuticals, Napo Therapeutics and Jaguar Animal Health
Jaguar Health, Inc. is a commercial-stage pharmaceutical company focused on developing novel herbal, non-opioid, and sustainably-derived prescription medicines for people and animals with gastrointestinal disorders, including chronic and debilitating diarrhea. Jaguar Health’s wholly-owned subsidiary, Napo Pharmaceuticals, Inc., is focused on the development and commercialization of proprietary human plant-based pharmaceutical products from plants responsibly harvested from rainforest areas. Our product candidate, crofelemer, is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for the prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Jaguar Health is the majority shareholder of Napo Therapeutics SpA (f/k/a Napo EU SpA), an Italian company established by Jaguar Health in Milan, Italy, in 2021, which focuses on expanding access to crofelemers in Europe. Jaguar Animal Health is a trading name of Jaguar Health.
For more information about Jaguar Health, visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com.
Certain statements contained in this press release constitute “forward-looking statements”. In some cases, you can identify forward-looking statements by words such as “may”, “will”, “should”, “expect”, “plan”, “aim”, “anticipate”, ” could”, “intend”, “target”, “project”, “consider”, “believe”, “estimate”, “predict”, “potential”, or “continue” or the negative form of these terms or other similar expressions. The forward-looking statements contained in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections regarding future events. These forward-looking statements speak only as of the date of this press 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 does not intend to publicly update or revise the statements forward-looking statements contained herein, whether as a result of new information, future events, changed circumstances or otherwise.
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