Jaguar Health subsidiary Napo Pharmaceuticals' OnTarget trial adding international sites, targeting completion of enrollment in Q2 2023
SAN FRANCISCO, CA / ACCESSWIRE / November 21, 2022 / Jaguar Health, Inc. (NASDAQ:JAGX) and its wholly owned subsidiary Napo Pharmaceuticals (Napo) today announced that Napo hosted a hybrid symposium on November 18, 2022 titled Management of Cancer Therapy-related Diarrhea: Is it time for a paradigm shift? The symposium featured presentations by leading oncology and infectious disease experts and discussed the impact of cancer therapy-related diarrhea (CTD) as well as the unmet need of CTD burden based on current management guidelines.
The symposium also discussed the need for prophylaxis of diarrhea in cancer patients as a paradigm-shift to mitigate the impact of CTD on activities of daily living (ADL), cancer therapy dose reductions, and/or discontinuations and overall improvement in the quality of life (QOL) of cancer patients receiving targeted therapy with or without standard chemotherapy. Additionally, 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 features of the ongoing phase 3 pivotal clinical study evaluating the safety and efficacy of crofelemer as prophylaxis for CTD in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy (Protocol NP303-102; OnTarget study). The symposium was attended in-person by some of the investigators in the OnTarget study as well as remotely by investigators from various clinical sites within 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, Napo Pharmaceuticals' and Jaguar Health's Chair of the Scientific Advisory Board and Chief Scientific Officer. "We are grateful to the clinical and scientific leaders of the oncology community that joined us to discuss the limitations of CTD management guidelines and the potential impact of crofelemer for prophylaxis of CTD. The content from the symposium will provide existing and prospective clinical investigators more background on the value of prophylaxis of CTD 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: Leading breast cancer medical oncologist and hematologist who serves as Chief of Medical Oncology and Hematology at the 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 & 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: Napo Pharmaceuticals' and Jaguar Health's Chair of Scientific Advisory Board and Chief Scientific Officer.
- Darlene Horton, MD: Napo Pharmaceuticals' Chief Medical Officer.
- Allison Shrier, MD: Napo Pharmaceuticals' Vice President of Clinical Research and Medical Affairs.
About Cancer Therapy-related Diarrhea
A significant proportion of patients undergoing cancer therapy experience diarrhea, and diarrhea has the potential to cause dehydration, potential infections, and non-adherence to treatment in this population. Novel "targeted cancer therapy" agents, such as epidermal growth factor receptor (EGFR) antibodies and tyrosine kinase inhibitors (TKIs), with or without cycle chemotherapy agents, may cause increased electrolyte and fluid content in the gut lumen, which results in passage of loose/watery stools (i.e., diarrhea). Diarrhea has been reported as one of the most common side effects of TKIs and may result in cancer therapy drug holidays or reductions from therapeutic dose, potentially impacting patient outcome. Diarrhea is also a common side effect of some approved CDK 4/6 inhibitors.
Crofelemer is a novel, oral plant-based medicine purified from the red bark sap, also referred to as "dragon's blood," of the medicinal Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established 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 & Jaguar Animal Health
Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, non-opioid, and sustainably derived prescription medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar Health's wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Our crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Jaguar Health is the majority shareholder of Napo Therapeutics S.p.A. (f/k/a Napo EU S.p.A.), an Italian corporation established by Jaguar Health in Milan, Italy in 2021 that focuses on expanding crofelemer access in Europe. Jaguar Animal Health is a tradename of Jaguar Health.
Certain statements in this press release constitute "forward-looking statements." 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.
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SOURCE: Jaguar Health, Inc.