Immuron Announces First Patients Enrolled in Travelan® Clinical Study
2023年7月25日 - 7:00PM
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and
globally integrated biopharmaceutical company is pleased to
announce the first cohort of 30 participants have been enrolled
into the clinical trial to evaluate the efficacy of Travelan® to
prevent infectious diarrhea caused by enterotoxigenic Escherichia
coli (ETEC).
The clinical study is being led by Principal
Investigator Dr Mohamed Al-Ibrahim at the Pharmaron CPC FDA
inspected Clinical Research Facility Inpatient Unit located in
Baltimore, Maryland US. The Phase 2 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. ClinicalTrials.gov Identifier: NCT05933525.
The first cohort of 30 participants is
anticipated to complete dosing and the in-patient stage of the
study by the first week of August 2023. The final 30 participants
are anticipated to be enrolled into the study and complete the
in-patient stage of the study by the end of October 2023. Headline
results from the clinical trial expected to be reported in 1H
2024.
The U.S. Department of Defense Uniformed
Services University is also running a randomized clinical trial
with Travelan® in up to 868 participants (ASX announcement January
18, 2023). ClinicalTrials.gov Identifier: NCT04605783. The USU has
reported that to date it has successfully enrolled 347 participants
into the clinical study following the initiation of enrolment and
approximately 260 have completed the study. USU has extended the
enrolment period and now expects to complete clinical trial
enrolment in Q2 2024.
Infectious diarrhea is the most common illness
reported by travelers visiting developing countries and among US
troops deployed overseas. The morbidity and associated discomfort
stemming from diarrhea decreases daily performance, affects
judgment, decreases morale and declines operational readiness. The
first line of treatment for infectious diarrhea is the prescription
of antibiotics. Unfortunately, in the last decade, several enteric
pathogens have demonstrated increasing resistance to commonly
prescribed antibiotics. In addition, travelers' diarrhea is now
recognized by the medical community to result in post-infectious
sequelae, including post-infectious irritable bowel syndrome (IBS)
and several post-infectious autoimmune diseases. A preventative
treatment that defends against infectious enteric diseases is a
high priority objective for the US Military.
This release has been authorised by the
directors of Immuron Limited.
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COMPANY
CONTACT:Steven LydeamoreChief Executive
OfficerPh: +61 (0)3 9824
5254info@immuron.com |
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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
Immuron (NASDAQ:IMRN)
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Immuron (NASDAQ:IMRN)
過去 株価チャート
から 5 2023 まで 5 2024