Full Press Release Details
DoD Naval Medical Research Center Receives FDA Guidance on the clinical development plans for new oral therapeutic
Australia, July 20, 2020: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing
and commercializing oral immunotherapeutics for the prevention and treatment of gut mediated pathogens, today is pleased to announce
that the Naval Medical Research Center (NMRC) has received written guidance from the U.S.
Food and Drug administration (FDA) in relation to the clinical development pathway of a new investigational drug which the company
is developing to treat moderate to severe campylobacteriosis and Enterotoxigenic Escherichia coli (ETEC) infections.
Type B meeting with the FDA discussed the Chemistry, Manufacturing and Controls including the proposed release testing specifications
of the product as well as the planned clinical studies evaluating the safety and efficacy of the product which the company is
developing to prevent Campylobacter and ETEC mediated moderate to severe diarrhea.
FDA were recently provided a Pre- Investigational New Drug (IND) package for the new Hyper-immune therapeutic which specifically
targets Campylobacter jejuni capsule and Enterotoxigenic Escherichia coli (ETEC) colonization factor antigen 1. Following FDA
review the agency provided a written response to the non-clinical questions posed in the briefing documentation as well as providing
additional guidance and comments to support the planned IND submission.
is an important milestone in the development of any new drug for therapeutic evaluation. The information obtained from this review
will assist in the development of the IND application and provides a clear roadmap forward for conducting the two planned clinical
studies next year" said Dr. Jerry Kanellos, CEO of Immuron Ltd. "The company is also please to inform shareholders
that the manufacturing program is proceeding as planned. We have completed the second immunisation campaign and are on schedule
to harvest the Hyper-immune colostrum in September this year which will be used to manufacture the drug product that will be used
to treat moderate to severe campylobacteriosis and ETEC infections."
release has been authorised by the directors of Immuron Limited.
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 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.
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.
more information visit: http://www.immuron.com
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