US Department of Defense Research Collaboration Moves Forward
July 24 2018 - 6:28AM
Key Highlights:
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).
The 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.
“Travelan 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.
“The 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.
The 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.
The following studies undertaken by US DoD
research units confirm the efficacy of Travelan:
US 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:
- React with the major colonization factor antigens
- Bind to key fimbrial proteins which are used by the bacteria to
attach to host cells and cause disease
- Inhibit the bacteria binding and causing cell
hemagglutination
- React with the heat labile enterotoxin produced by ETEC
bacteria
Walter 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.
The above studies add to the previous research
reported in January 2018 summarised below:
Armed 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 AFRIMS.
The 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.
The company is also please to reported 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.
Furthermore, 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 of the product.
COMPANY CONTACT: Jerry
KanellosChief Executive Officer (Interim)Ph: +61 (0)3 9824
5254jerrykanellos@immuron.com |
USA INVESTOR RELATIONS:
Jon CunninghamRedChip Companies, Inc.US Ph: +1
(407) 644 4256, (ext. 107)jon@redchip.com |
AUS INVESTOR RELATIONS:
Peter TaylorNWR CommunicationsPh: +61 (0)4 1203
6231peter@nwrcommunications.com.au |
ABOUT IMMURON:
Immuron 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.
For more information visit:
http://www.immuron.com
About Travelan®
Travelan® 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
indistinguishable.
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