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Jaguar Health Announces that Interim Analysis Requirement Met in Phase 2 HALT-D Study Evaluating Mytesi (Crofelemer) for Prevention and Prophylaxis of Diarrhea in Breast Cancer Patients
SAN FRANCISCO, CA / ACCESSWIRE / November 14, 2019 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company"), today announced that Georgetown
About this update from Jaguar Health, Inc.
[{"type":"text","content":"SAN FRANCISCO, CA / ACCESSWIRE / November 14, 2019 / Jaguar Health, Inc. (NASDAQ:JAGX) (\"Jaguar\" or the \"Company\"), today announced that Georgetown University's Data Safety Monitoring Committee (\"DSMC\") has reviewed the interim analysis for futility for the third-party, investigator-initiated Phase 2 HALT-D study evaluating the effectiveness of Mytesi® (crofelemer) for symptomatic relief in HER2 positive breast cancer patients receiving chemotherapy with trastuzumab, pertuzumab, and docetaxel or paclitaxel or trastuzumab, pertuzumab, carboplatin, and docetaxel (the \"Study\"). The DSMC has notified the Principal Investigator that the Study is allowed to enroll to completion. Enrollment in the Study now exceeds 85%, and the treatment period for each patient is 3 months.\"We're very pleased to have been informed of the DSMC's decision and to see this important study milestone - ‘Positive Interim Results' as defined in the July 2019 Company prospectus - achieved,\" Lisa Conte, Jaguar's president and CEO commented. \"Although this Study is not required to support the clinical program for Mytesi (crofelemer) for FDA approval for cancer therapy-related diarrhea, the final results may inform us about potential exploratory clinical endpoints for our planned Phase 3 clinical study for cancer therapy-related diarrhea and development activities aimed at additional indications for Mytesi.\"As previously announced, the protocol for the HALT-D Study is a randomized, 1:1, stratified, open-label phase II study in patients with HER2 positive breast cancer receiving trastuzumab, pertuzumab, and docetaxel or paclitaxel with or without carboplatin in any setting for three cycles. Mytesi (crofelemer) tablets are administered daily at an oral dose of 125 mg twice daily during cycles 1 and 2 of the treatment period. The endpoints to be analyzed are the total number of patients with all grade diarrhea for two or more consecutive days during cycles 1 and 2 and additional exploratory endpoints. The Study, which is sponsored by Georgetown University and funded by Genentech, a member of the Roche Group, called for an interim analysis for futility when the Study enrollment reached 50%. This interim analysis has now been completed and the Georgetown DSMC has indicated to the Principal Investigator that the Study is allowed to enroll to completion.As re...