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Jaguar Health Announces Activation of Investigational New Drug (IND) for Crofelemer (Mytesi) for Prophylaxis and Symptomatic Relief of Cancer Therapy‑Related Diarrhea
A significant proportion of patients undergoing cancer therapy experience diarrheaSAN FRANCISCO, CA / ACCESSWIRE / August 6, 2020 / Jaguar Health, Inc.
About this update from Jaguar Health, Inc.
[{"type":"text","content":"A significant proportion of patients undergoing cancer therapy experience diarrheaSAN FRANCISCO, CA / ACCESSWIRE / August 6, 2020 / Jaguar Health, Inc. (NASDAQ:JAGX) (\"Jaguar\" or the \"Company\") announced today the activation of the investigational new drug (IND) application filed by the Company's wholly owned subsidiary Napo Pharmaceuticals, Inc. (\"Napo\") with the U.S. Food and Drug Administration (FDA) for the use of crofelemer (Mytesi®) for prophylaxis and symptomatic relief of diarrhea in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy (\"cancer therapy‑related diarrhea\" (CTD)). Activation of this IND is a key milestone for Napo to initiate its pivotal trial with Mytesi in CTD in adult solid tumor patients.\"We are very pleased that Napo's IND for CTD is now active,\" Lisa Conte, Jaguar's president and CEO, stated. \"Many cancer patients on targeted therapy require drug holidays or dose reductions in their therapy due to diarrhea. Reducing frequency of watery stools will provide symptomatic relief of diarrhea and may allow better adherence to the therapeutic dosing of targeted therapies and/or chemotherapy, potentially leading to better clinical outcomes. In addition to tumor burden reduction, the adoption and/or continued use of targeted cancer therapies is also related to the ability of patients to tolerate their cancer therapies - highlighting the potential importance of Mytesi to help manage cancer treatment-related diarrhea in this patient population. Our planned study for diarrhea related to CTD will use the same formulation and dosing that is used for the current commercialized Mytesi for the symptomatic relief of HIV/AIDS associated diarrhea in adult patients receiving antiretroviral therapy.\"According to the Centers for Disease Control and Prevention (CDC), approximately 650,000 cancer patients in the U.S. receive chemotherapy in an outpatient oncology clinic each year. 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 a...