Full Press Release Details
and CSIRO to produce a new oral therapeutic for clinical evaluation by the US Department of Defense
Australia, June 19, 2020: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing
and commercialising oral immunotherapeutics for the prevention and treatment of gut mediated pathogens, today is pleased to provide
shareholders with an update on the progress made to date on the company's research collaboration with the Naval Medical
Research Center (NMRC) previously announced in October 2019.
has now executed a research agreement with Australia's national science agency, CSIRO. to
produce the new therapeutic against Campylobacter and Entero-Toxigenic Escherichia coli
(ETEC) for clinical evaluation by the US Department of Defense. Under
the terms of the research agreement CSIRO has been engaged to produce a hyper-immune bovine colostrum product using vaccines developed
by the NMRC. The work will be conducted at the Department of Agriculture and Water Resources Biosecurity Approved Arrangement
facilities located in Armidale NSW.
is the second R&D program CSIRO has been engaged to undertaken recently with Immuron" said CSIRO's Dr Peter
Hunt, principal research scientist.
are pleased to once again offer the services, expertise and facilities of CSIRO to produce this new therapeutic product for clinical
assessment by the Naval Medical Research Center (NMRC). Approval was obtained from
Biosecurity Australia early this year to import the NMRC vaccines and they have been in storage since the COVID-19 pandemic hit
the world. I am pleased to report the vaccination campaign has been finally initiated and the finished product should be available
by the end of this year."
is also pleased to inform shareholders that the NMRC submitted the Pre-IND information
package as planned on the 10th of June 2020 and expects to receive written comments on the non-clinical information
from the U.S. Food and Drug Administration (FDA) within 30-days regarding its planned investigational new drug application to
treat moderate to severe campylobacteriosis and ETEC infections. The company has also recently fully executed the Research Subaward
Agreement with The Henry M. Jackson Foundation for Advancement of Military Medicine Inc. the Pass-Through Entity managing the
CEO, Dr Jerry Kanellos commented.
are grateful that the CSIRO is such a strong supporter of the Australian Biotechnology Industry. The current program is now back
on track and we will have the hyper-immune bovine colostrum harvested in September 2020. The drug substance and drug product will
be manufactured by the end of this year and will be available for the clinical development program to prevent acute infectious
diarrhea which the NMRC plans to initiate early next year."
release has been authorised by the directors of Immuron Limited.
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.
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 generating revenue. In Australia, Travelan is a listed medicine on
the Australian Register of 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 licenced 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 in accordance with section 403 (r)(6) of the Federal Drug Administration (FDA).
is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting travelers' diarrhea,
a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins
they produce. 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.
more information visit: http://www.immuron.com
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