New U.S. Department of Defense Research Collaboration with Immuron to Develop and Clinically evaluate a New Therapeutic again...
October 02 2019 - 9:00AM
Immuron Limited (ASX: IMC; NASDQ: IMRN), an Australian
biopharmaceutical company focused on developing and commercializing
oral immunotherapeutics for the prevention and treatment of gut
mediated pathogens, is pleased to announce the funding of a new
research agreement with the Naval Medical Research Center (NMRC),
Silver Spring, MD, USA.
The focus of this new agreement will be to
develop a combined Campylobacter and enterotoxigenic E. coli
(ETEC)-specific anti-microbial preventative for clinical
evaluation. Under this agreement, Immuron and NMRC will be
collaborating on the manufacture and evaluation of the new product
designed to protect against travelers’ diarrhea caused by
Campylobacter and ETEC pathogens. The protective efficacy of the
product will be tested utilizing two controlled human
infection-model clinical trials, with one trial focusing on the
ability of the hyperimmune product to protect volunteers against
moderate to severe campylobacteriosis, and the second trial
focusing on ETEC infections.
“The good news is that we just had the
confirmation that the funds were transferred, and we are ready and
eager to start the project,” said Dr. Frédéric Poly, Head
of the Campylobacter research division, Enteric Diseases Department
at NMRC. “Deployed military personnel are a unique
population of travelers that have a long history of being affected
by acute infectious diarrhea. Campylobacter jejuni and ETEC are
leading causes of travelers’ diarrhea and represent a major burden
for deployed U.S. troops. And despite robust research efforts to
develop vaccines against major enteric pathogens, there are
currently no licensed vaccines available. To address this unmet
need, we will be utilizing our own vaccine expertise along with
Immuron’s proprietary technology platform to develop an oral
preventative product which directly targets pathogenic bacteria at
the site of infection within the gastrointestinal tract. We have
previously shown that the ETEC vaccine is immunogenic in small
animal models and demonstrated that Campylobacter jejuni vaccines
were 100% protective against campylobacteriosis in the non-human
primate model. We have also independently developed a prophylactic
anti-diarrheal oral bovine colostrum-derived immunoglobulin product
and demonstrated protective efficacy against an ETEC strain in a
controlled human infection model (CHIM).”
Dr. Frédéric Poly of
the NMRC goes on to say: “The ultimate goal of this
research effort is to lay the scientific foundation for development
of a multi-pathogen product that confers protection against both C.
jejuni and ETEC, the predominant causes of infectious diarrhea in
deployed warfighters. Ultimately, the data resulting from these
studies will provide military policymakers with information needed
to make decisions on product acquisition and, if successful,
Immuron should be enabled to manufacture the product at scale to
meet the needs of military personnel and the traveling community on
an ongoing basis.”
“This is wonderful news,” said Dr. Gary
S. Jacob, CEO of Immuron. “The new project expands our
anti-infectious diseases clinical development program to include
this Campylobacter project with the U.S. Department of Defense,
covering an additional key pathogen, Campylobacter, responsible for
travelers’ diarrhea. Along with our current program with the Walter
Reed Army Institute of Research which is focused on Shigella, this
project highlights the continued commitment Immuron is making to
use our hyperimmune bovine polyclonal colostrum technology to
benefit the U.S. Military as well as the civilian population. This
program also further enhances our efforts to raise the profile of
our flagship product Travelan® and our in-house clinical program to
develop IMM-124E as an FDA approved drug to prevent Travelers’
Diarrhea.”
Infectious diarrhea is the most common illness
reported by travelers visiting developing countries and among U.S.
troops deployed overseas. Diarrhea morbidity decreases daily
performance, affects judgment, decreases morale and declines
operational readiness. The first line of treatment for infectious
diarrhea is prescription of antibiotics. Unfortunately, in the last
decade, several enteric pathogens have an 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 and several post-infectious autoimmune diseases.
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 U.S.
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
being developed as a drug to prevent 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.
For more information visit:
http://www.immuron.com
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. U.S. Ph: +1 (407) 491 4498
dave@redchip.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 Travelers’ 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 Travelers’
Diarrhea. In the U.S., Travelan® is sold as a dietary supplement
for digestive tract protection.
About Travelers’
diarrheaTravelers’ diarrhea is a gastrointestinal
infection with symptoms that include loose, watery (and
occasionally bloody) stools, abdominal cramping, bloating, and
fever, Enteropathogenic 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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of 1933 and Section 21E of the Securities Exchange Act of 1934,
each as amended. Such statements include, but are not limited
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cause actual results to differ materially from those currently
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