US Department of Defense Uniformed Services University Clinical Evaluation of Travelan™
May 09 2022 - 5:00AM
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 a progress update on the planned clinical trial to
evaluate the efficacy of Travelan® and two third party
non-antibiotic products in Travelers’ Diarrhea
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 commercially
available 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 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).
USU have completed the manufacture of the first
batches of investigational medicinal products and shipment of these
to the first clinical trial sites is now complete. USU are
anticipating recruitment of study participants to commence in June
2022 and expect to complete clinical trial enrolment in
approximately 18 months.
The clinical protocol has also been amended to
extend the treatment period from 13 days to 22 days to cover the
COVID-19 quarantine period still required by some countries. The
extended time is necessary as those travelers required to
quarantine upon arrival who may be still at risk of diarrhea
symptoms during this period. The protocol amendment has now been
submitted to the ethics board for approval and recruitment will
commence once approval has been granted.
The Problem: Travelers’
diarrhea (TD) remains a highly prevalent disease that impacts
operational readiness of military personnel and is also
debilitating civilian travel. In addition to its acute morbidity,
TD is associated with acquisition of antimicrobial resistance genes
and long-term sequelae. Current mitigation strategies including
pre-travel counseling and antibiotics for prevention and treatment
have important limitations, and there are currently no licensed,
pathogen-specific vaccines for TD prevention.
The Approach: Prebiotics,
probiotics and passive immunotherapy may offer safe and relatively
inexpensive preventive strategies by promoting gut resistance to
enteropathogens, and potentially lessening the use of antibiotics.
USU’s Infectious Diseases Clinical Research Program (IDCRP), the UK
Ministry of Defense and the New York City Travel Clinic are jointly
conducting a randomized clinical trial to evaluate the efficacy of
these nutraceutical products for TD prevention and inform
strategies for Force Health Protection.
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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