Immuron Initiates Recruitment of Travelan® Clinical Study
30 Maggio 2023 - 12:00PM
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and
globally integrated biopharmaceutical company is pleased to
announce that it has received approval from the U.S. Army Medical
Research and Development Command (USAMRDC) Office of Human and
Animal Research Oversight (OHRO) to proceed with the clinical trial
to evaluate the efficacy of Travelan® to prevent infectious
diarrhea caused by enterotoxigenic Escherichia coli (ETEC).
The study has also been granted Institutional
Review Board (IRB) human ethics and US Food and Drug Administration
(FDA) approvals (ASX announcement December 23, 2022).
Immuron is now proceeding with the planned
clinical trial in the United States and has initiated
recruitment.
The clinical study will be conducted by
Pharmaron CPC at its FDA inspected Clinical Research Facility
Inpatient Unit located in Baltimore, Maryland US. The Phase II
clinical trial is designed to evaluate the safety and protective
efficacy of Travelan® compared to a placebo in a controlled human
infection model (CHIM). The primary efficacy outcome is prevention
and/or reduction of moderate to severe diarrhea.
This week Pharmaron initiated recruitment of up
to 60 healthy participants (males or non-pregnant, non-nursing
females), aged 18-50 years on the Pharmaron Website.
https://www.pharmaron.com/clinical-trials/current-trials
The first cohort of 30 participants is
anticipated to be enrolled and dosed by the end of July 2023. The
final 30 participants are anticipated to be enrolled into the study
in October 2023. Headline results from the clinical trial expected
to be reported in 1H 2024.
This is one of four clinical trials Immuron has,
or is soon to, initiate. The U.S. Department of Defense Uniformed
Services University is running a randomized clinical trial of
Travelan® in up to 868 participants (ASX announcement January 18,
2023). ClinicalTrials.gov Identifier: NCT04605783.
https://clinicaltrials.gov/ct2/show/NCT04605783?term=NCT04605783&draw=2&rank=1
The FDA recently removed a clinical hold on two
planned Phase 2 trials of Campylobacter ETEC therapeutic paving way
for initiation (ASX announcement May 8, 2023).
This release has been authorised by the
directors of Immuron Limited.
COMPANY CONTACT:Steven
LydeamoreChief Executive OfficerPh: +61 (0)3 9824
5254info@immuron.com
About ImmuronImmuron Limited
(ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical
company focused on developing and commercializing orally delivered
targeted polyclonal antibodies for the treatment of inflammatory
mediated and infectious diseases.
For more information visit:
http://www.immuron.com
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