Full Press Release Details
Department of Defense Research Collaboration Moves Forward
Australia, July 16, 2018: Immuron Limited (ASX: IMC; NASDQ: IMRN), an Australian microbiome biopharmaceutical company focused
on developing and commercializing oral immunotherapeutics for the 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).
US DoD commissioned several studies to characterise the antibodies within Travelan, the company's commercially available
flagship over-the-counter gastrointestinal and digestive health supplement. The aim is to progress trials to determine Travelan's
effectiveness in neutralising pathogenic gastrointestinal bacterial infections as a preventative treatment for US military personnel
stationed in locations where such infections may be debilitating.
has been designed to target selected surface antigens from the most common strains of Enterotoxigenic E. coli (ETEC), bacteria
which play a dominant and causative role in Travellers' diarrhea," said Dr. Jerry Kanellos, CEO of Immuron.
work completed at the US Armed Forces Research Institute of Medical Sciences, US Naval Medical Research Center and the Walter
Reed Army Institute of Research has highlighted that in laboratory testing Travelan was effective across all strains and species
of enteropathogenic bacteria tested. The specificity of antibodies incorporated into Travelan cross-react with multiple Campylobacter,
ETEC and Shigella strains. The product is truly cross-reactive indicating a substantially broader spectrum of antimicrobial action
than previously reported. This new research offers a pathway to further testing which could lead to a major new preventative modality
for the US DoD," concluded Dr. Kanellos.
global burden of diarrhoeal 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 Shigella, is a high priority objective for the US Army. Shigella
is 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.
following studies undertaken by US DoD research units confirm the efficacy of Travelan:
Naval Medical Research Center (NMRC) Study demonstrated Travelan bound to and neutralized key components used
by the ETEC bacteria to attach to host cells and cause disease. This study was performed by the NMRC's Department of Enteric
Infections and reported that Travelan was specifically shown to:
Reed Army Institute of Research (WRAIR) Study demonstrated Travelan bound to similar targets
present on ETEC and Shigella bacteria. The Department of Enteric Infections, Bacterial Diseases Branch at the WRAIR assessed Travelan
immune-reactivity with ETEC and Shigella antigens, which demonstrated they were reacting to common bacterial antigens.
above studies add to the previous research reported in January 2018 summarised below:
Forces Research Institute of Medical Sciences (AFRIMS) Study demonstrated_Travelan effectively
reacted to 180 clinical isolates tested from personnel infected with Campylobacter, Enterotoxigenic Escherichia coli
(ETEC) and Shigella. This first study involving Travelan was performed at the Department of Enteric Diseases of
research and development program will now progress to evaluate the therapeutic potential of Travelan in Shigellosis
Challenge studies. AFRIMS will fund and evaluate the therapeutic potential of Travelan in Non-Human primate (NHP)
clinical studies which replicates the full clinical spectrum of the disease as seen in humans. The plan studies will be performed
at the Department of Enteric Diseases of
AFRIMS, an overseas laboratory of the WRAIR, located in Bangkok, Thailand and will be initiated at the end of July 2018.
company is also pleased to report that it has once again engaged the services and facilities of the Commonwealth Scientific &
Industrial Research Organisation (CSIRO) to produce three Shigella therapeutic products for preclinical assessment by the WRAIR.
Approval was obtained from Biosecurity Australia early this year to import the Shigella specific vaccines developed and produced
by the WRAIR which will be used to manufacture the products. The vaccination program will be initiated in August this year and
the finished products should be available by the end of the calendar year. Under the current terms of the Cooperative Research
Agreement the WRAIR will fund the evaluation of the anti-Shigella therapeutics and assess their protective capacity in established
small animal models.
the Campylobacter research team at the NMRC and Immuron have recently submitted a grant funding proposal for the development of
a therapeutic product against campylobacter and other enteric pathogens. If approved the US DoD will fund the clinical development
Limited (ASX: IMC, NASDAQ: IMRN), is an Australian microbiome biopharmaceutical company focused on developing and commercializing
orally delivered targeted polyclonal antibodies for the treatment of inflammatory mediated and infectious diseases. Immuron has
a unique and safe technology platform that enables a shorter development therapeutic cycle. The Company currently markets and
sells Travelan for the prevention of Travelers' Diarrhoea and its lead clinical candidate, IMM-124E, is in Phase II
clinical trials for Non-Alcoholic Steatohepatitis (NASH), Severe Alcoholic Hepatitis (SAH) and Pediatric Nonalcoholic
Fatty Liver Disease (NAFLD). Immuron's second clinical stage asset, IMM-529, is targeting Clostridium difficile
Infections (CDI). These products together with the Company's other preclinical immunotherapy pipeline products targeting
immune-related diseases currently under development, will meet a large unmet need in the global immunotherapy market.
more information visit: http://www.immuron.com
is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting travellers'
diarrhoea. Travelan is a highly purified tabletised preparation of hyper immune bovine antibodies and other factors, which
when taken with meals bind to diarhoea-causing bacteria and prevent colonization and the pathology associated with travellers'
diarrhoea. In Australia Travelan is approved by the Therapeutic Goods Administration (TGA) as a listed medicine on the Australian
Register of Therapeutic Goods (AUST L106709) and is indicated to reduce the risk of travellers' diarrhoea and associated
symptoms of minor gastrointestinal disorders. In the USA Travelan is sold as a dietary supplement in accordance with section
403 (r)(6) of the Federal Drug Administration (FDA).
About Travellers' diarrhea
Travellers' diarrhoea
is a gastro-intestinal 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 travellers' diarrhoea as they may be contracted while travelling and initial symptoms are often
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