US Department of Defense Reports Final Results from Travelan® Shigellosis Challenge Study
June 12 2019 - 7:00AM
Immuron Limited (ASX: IMC; NASDQ: IMRN), an Australian
biopharmaceutical company focused on developing and commercializing
oral immunotherapeutics for the prevention and treatment of many
gut mediated pathogens, today is pleased to provide shareholders
with an update on the company’s cooperative research and
development agreements with the US Department of Defense (US DoD).
The Shigella challenge model was used to assess
the therapeutic potential of Travelan® as a prevention treatment
for shigellosis or dysentery. The placebo-controlled study was
carried out in 12 juvenile rhesus monkeys segregated into 2 groups:
a Travelan® treatment cohort of 8 and a placebo cohort of 4, which
were treated twice daily for a total of 12 doses over a 6-day
period. The animals received treatment for 3-days prior to oral
challenge with ~3 x 109 viable Shigella organisms.
As reported in September last year, all (4 of 4
- 100%) placebo-treated animals displayed acute clinical signs of
dysentery within 24 – 36 hours of Shigella challenge. Only two of
the eight Travelan-treated group displayed any signs of dysentery.
The remaining 6 of 8 (75%) of the Travelan-treated group remained
healthy and without signs of dysentery post challenge. Recently
completed histopathological analysis, which provides a
comprehensive view of the clinical disease and its effect on
tissues of gut, revealed that all animals in the placebo-treated
group displayed severe inflammation in different parts of the
gastrointestinal tract. These animals also had very high levels of
inflammatory cytokines (IL-1b, IL-6 and IL-8) in fecal samples
collected throughout the study. The inflammation seen in the
gastrointestinal tract and the increase in inflammatory cytokines
in the feces were closely associated with the observed clinical
outcomes of dysentery. Only 3 of the 8 Travelan-treated animals had
signs of inflammation in the gastrointestinal tract, and only 2 of
those had high levels of inflammatory cytokines in fecal samples.
All other animals in the Travelan-treated group were clinically
healthy and did not excrete any inflammatory cytokines. Overall the
results suggest that Travelan® is functionally cross-reactive and
may have some prophylactic activity against Shigellosis.
“The latest results reported by our colleagues
at the US Armed Forces Research Institute of Medical Sciences
(AFRIMS), an overseas laboratory of the Walter Reed Army Institute
of Research (WRAIR), located in Bangkok, Thailand are very
impressive indeed. The study results clearly demonstrated that
animals with severe inflammation in the gastrointestinal tract and
high inflammatory cytokines in fecal samples were associated with
severe dysentery and that prophylactic administration of Travelan®
significantly reduced the inflammatory response,” said Dr.
Robert Kaminski, Chief, Subunit Enteric Vaccines and Immunology,
Department of Enteric Infections, Bacterial Diseases Branch,
WRAIR.
The abstract of the study findings has been
submitted for presentation at the 10th International conference on
Vaccines for Enteric Diseases which will be held at the University
of Lausanne Switzerland on the 16th to 18th October 2019.
“This is further validation of our technology
platform,” said Dr. Gary Jacob, CEO of Immuron.
“The work completed by our research collaborators at the WRAIR has
clearly demonstrated the effectiveness of Travelan® and the Immuron
technology platform in neutralizing pathogenic gastrointestinal
bacterial infections and offers significant potential as a
preventative treatment for US military personnel and civilians
stationed or traveling in locations where such infections may be
debilitating.”
The company is also pleased to report that it
has completed the manufacture of three new Shigella specific
therapeutic products which have been manufactured with proprietary
vaccines developed by the WRAIR. Preliminary laboratory evaluation
has indicated that all three products have generated a strong
antibody response to the Shigella antigens used in the
manufacturing campaign. The three products will be evaluated in
preclinical models of shigellosis developed by the WRAIR.
“The WRAIR has been developing vaccines against
Shigella for over a decade and the combination of our Shigella
vaccine research and development efforts with Immuron’s oral
immunotherapy platform make perfect sense. The WRAIR will fund the
evaluation of the anti-Shigella specific activity of the new
products including assessing their protective capacity in
established small animal models which will be completed and
reported throughout the remainder of this year,” said Dr.
Robert Kaminski.
The global burden of diarrheal diseases
outweighs any of the more complex diseases seen in gastroenterology
clinics. Every year, there are an estimated 1.5 billion episodes of
diarrhea worldwide. These episodes result in the deaths of
approximately 2.2 million people, mostly children in developing
countries (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2699001/).
A preventative treatment that protects against enteric diseases,
specifically shigellosis, is a high priority objective for the US
Army. Shigella spp are estimated to cause 80 –165 million cases of
disease worldwide, resulting in 600,000 deaths annually and is
particularly prevalent in both sub-Saharan Africa and South
Asia.
ABOUT IMMURON:Immuron 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. Immuron has a novel and safe
technology platform with one commercial asset Travelan® generating
revenue. Immuron’s lead clinical candidate, IMM-124E, is presently
in Phase II trials in Severe Alcoholic Hepatitis (SAH) and
Paediatric Non-alcoholic Fatty Liver Disease (NAFLD). The company
now has plans to develop a U.S. registration dossier for IMM-124E
for Travelers’ Diarrhea. Immuron’s second clinical-stage asset,
IMM-529, targets Clostridium difficile Infections (CDI), and is
presently in a clinical trial in CDI patients. These products
together with the Company’s other preclinical immunotherapy
pipeline products currently under development targeting
immune-related and infectious diseases are anticipated to meet
pressing needs in the global immunotherapy market.
COMPANY CONTACT:Gary S. Jacob,
Ph.D.Chief Executive OfficerPh: +61 (0)3 9824
5254info@immuron.com |
AUS INVESTOR RELATIONS:Peter
TaylorNWR CommunicationsPh: +61 (0)4 1203
6231peter@nwrcommunications.com.au |
USA INVESTOR RELATIONS:Dave Gentry -
CEO RedChip Companies, Inc. US Ph: +1 (407) 491
4498 dave@redchip.com |
For more information visit:
http://www.immuron.com
About
Travelan®Travelan® is an orally administered
passive immunotherapy that prophylactically reduces the likelihood
of contracting travelers’ diarrhea. Travelan® is a highly purified
tabletized preparation of hyper immune bovine antibodies and other
factors, which when taken with meals bind to diarrhea-causing
bacteria and prevent colonization and the pathology associated with
travelers’ diarrhea. In Australia, Travelan® is a listed medicine
on the Australian Register for Therapeutic Goods (AUST L 106709)
and is indicated to reduce the risk of Travellers’ Diarrhea, reduce
the risk of minor gastro-intestinal disorders and is antimicrobial.
In Canada, Travelan® is a licensed natural health product (NPN
80046016) and is indicated to reduce the risk of Travellers’
Diarrhea. In the U.S., Travelan® is sold as a dietary supplement
for digestive tract protection.
About Travellers’
diarrheaTravelers’ diarrhea is a gastrointestinal
infection with symptoms that include loose, watery (and
occasionally bloody) stools, abdominal cramping, bloating, and
fever, Entropathogenic bacteria are responsible for most cases,
with enterotoxigenic Escherichia coli (ETEC) playing a dominant
causative role. Campylobacter spp. are also responsible for a
significant proportion of cases. The more serious infections with
Salmonella spp. the bacillary dysentery organisms belonging to
Shigella spp. and Vibrio spp. (the causative agent of cholera) are
often confused with travelers’ diarrhea as they may be contracted
while travelling and initial symptoms are often
indistinguishable.
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