US DoD Uniformed Services University Travelers’ Diarrhea Clinical Update
November 15 2021 - 6:00AM
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian
biopharmaceutical company focused on developing and commercializing
oral immunotherapeutic products for the prevention and treatment of
gut pathogens, today is pleased to provide shareholders and the
market with an update on the planned clinical trial program to
evaluate the efficacy of Travelan® and two other non-antibiotic OTC
products in Travelers’ Diarrhea sponsored by the Uniformed Services
University of the Health Sciences (USU).
USU have initiated the manufacturing campaign to
produce the first batches of investigational medical products in
November 2021 to support the planned clinical trial program to
evaluate the efficacy of Travelan® and two other dietary supplement
products in Travelers’ Diarrhea. USU are anticipating an enrollment
start date of April 2022 for the planned clinical trial and are
hoping to complete enrollment in approximately 18 months. USU’s
Infectious Diseases Clinical Research Program (IDCRP), the UK
Ministry of Defense and the New York City Travel Clinic are jointly
planning to conduct the randomized clinical trial to evaluate the
efficacy of three nutraceutical products for TD and inform
strategies for Defense Force Health Protection. The P4TD study is a
randomized, double-blind, placebo controlled multicenter clinical
trial designed to evaluate the effectiveness of 3 commercially
available nutraceuticals: A prebiotic (Bimuno®), a probiotic
(Florastor®) and IMM-124E (Travelan®) passive immunoprophylaxis
verses a placebo, for prophylaxis during deployment or travel to a
high-TD risk region (ClinicalTrials.gov Identifier:
NCT04605783).
All study participants (1336 in total) will be
randomized to one of the three active products or placebo (334 per
arm).
This release has been authorised by the
directors of Immuron Limited.
COMPANY
CONTACT:Dr Jerry
Kanellos, Ph.D.Chief Executive OfficerPh: +61 (0)3 9824
5254info@immuron.com |
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For more information visit:
http://www.immuron.com
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