US Department of Defense Reports Travelan Protects Against Shigella in Primates
September 05 2018 - 10:00AM
Key Highlights:
Immuron Limited (ASX: IMC; NASDQ: IMRN), an Australian microbiome
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 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 was to
conduct trials to determine the product’s effectiveness in
neutralising pathogenic gastrointestinal bacterial infections as a
preventative treatment for US military personnel and civilians
stationed or traveling in locations where such infections may be
debilitating.
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, conducted the study that evaluated the therapeutic
potential of Travelan® in a
non-human primate (NHP) preclinical challenge model that closely
mimics the disease seen in humans. The study was performed in
collaboration with the Department of Enteric Diseases and the
Department of Veterinary Medicine, AFRIMS, and the Department of
Enteric Infections, Bacterial Diseases Branch, WRAIR.
The placebo-controlled study was carried out in
12 NHPs segregated into 2 groups: a Travelan®
treatment cohort of 8 and a placebo cohort of 4, which were treated
with either Travelan® or placebo respectively
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 flexneri strain 2a organisms. All (4 of 4
- 100%) placebo-treated animals displayed acute dysentery symptoms
within 24 – 36 hours of Shigella flexneri 2a challenge. A single (1
of 8 – 12.5%) of the
Travelan®-treated cohort displayed dysentery
symptoms at this time point. The remaining individuals (7 of 8 –
87.5%) in the Travelan® treatment
cohort remained symptom-free to 4-days post Shigella flexneri 2a
challenge. Once the treatment period was concluded a second
individual in the Travelan treatment group developed symptoms (2 of
8 - 25%).
The remainder (6 of 8 - 75%) of
the Travelan® treated cohort remained symptom-free
to the conclusion of the study 11-days post Shigella flexneri 2a
challenge.
“Travelan® was 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 Traveler’s diarrhea. Previous studies found
several of these antigens are shared with bacillary
dysentery-causing organisms such as Shigella species,” said Dr.
Jerry Kanellos, CEO of Immuron. “The work completed at AFRIMS
highlighted for the first time that in a preclinical NHP challenge
model of shigellosis (also known as bacillary dysentery),
Travelan® protected 75% of
the animals from clinical bacillary dysentery. All
the placebo-treated animals displayed classic dysentery symptoms
after challenge with a virulent strain of Shigella sp. It is also
very interesting to note the second case of dysentery in the
Travelan cohort developed once the treatment terminated.”
“The results from this study are very exciting
and provide a positive signal for future investigations” said Dr.
Robert Kaminski, Chief, Subunit Enteric Vaccines and Immunology,
Department of Enteric Infections, Bacterial Diseases Branch, WRAIR.
“We received funding to evaluate the Immuron Travelan product for
cross-reactivity with Campylobacter, other ETEC strains, and
Shigella using in vitro and in vivo methodologies. Our in vitro
data set clearly indicated that antibodies in the product cross
react with all bacterial pathogens tested. More recently, the NHP
study completed at AFRIMS demonstrated that Travelan protects
against shigellosis/dysentery in the model. All the animals treated
with placebo and then challenged with Shigella flexneri 2a, 2457T
became infected and had severe dysentery. Only 25% of the animals
(2 of 8) treated with Travelan and then challenged with S. flexneri
2a, 2457T had any constitutional/clinical symptoms. The results
from this study, in combination with the results from the in vitro
assays, suggest that the Travelan product offers protection/cross
reactivity from Shigella.”
“The results go some way in confirming that
Travelan® is effective across all strains and
species of enteropathogenic bacteria tested. They significantly
strengthen and extend previous results that demonstrated the
specificity of antibodies incorporated into
Travelan® cross-react with multiple enteric
pathogens, including Campylobacter, ETEC, Klebsiella, Salmonella
and Shigella strains. The current study demonstrates that the
Travelan® product is functionally cross-reactive
and prophylactically effective and confirms that
Travelan® has a substantially broader spectrum of
antimicrobial action than previously reported. These results offer
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.
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’
diarrheaTravellers’ 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.
FORWARD-LOOKING STATEMENTS:
This press release may contain
“forward-looking statements” within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934, each as amended. Such statements
include, but are not limited to, any statements relating to our
growth strategy and product development programs and any other
statements that are not historical facts. Forward-looking
statements are based on management’s current expectations and are
subject to risks and uncertainties that could negatively affect our
business, operating results, financial condition and stock value.
Factors that could cause actual results to differ materially from
those currently anticipated include: risks relating to our growth
strategy; our ability to obtain, perform under and maintain
financing and strategic agreements and relationships; risks
relating to the results of research and development activities;
risks relating to the timing of starting and completing clinical
trials; uncertainties relating to preclinical and clinical testing;
our dependence on third-party suppliers; our ability to attract,
integrate and retain key personnel; the early stage of products
under development; our need for substantial additional funds;
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competition; as well as other risks described in our SEC filings.
We expressly disclaim any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in our expectations or any
changes in events, conditions or circumstances on which any such
statement is based, except as required by law.
COMPANY CONTACT:
Jerry Kanellos
Chief Executive Officer (Interim)
Ph: +61 (0)3 9824 5254
jerrykanellos@immuron.com
USA INVESTOR RELATIONS:
Dave Gentry - CEO
RedChip Companies, Inc.
US Ph: +1 (407) 491 4498
dave@redchip.com
AUS INVESTOR RELATIONS:
Peter Taylor
NWR Communications
Ph: +61 (0)4 1203 6231
peter@nwrcommunications.com.au
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