US Department of Defense Reports Final Results from Travelan® Shigellosis Challenge Study

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MELBOURNE, Australia, June 12, 2019 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDQ: IMRN), an Australian 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 challenge model was used to assess the therapeutic potential of Travelan as a prevention treatment for shigellosis or dysentery. The placebo-controlled study was carried out in 12 juvenile rhesus monkeys segregated into 2 groups: a Travelan treatment cohort of 8 and a placebo cohort of 4, which were treated 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 10 viable organisms.

As reported in September last year, all (4 of 4 - 100%) placebo-treated animals displayed acute clinical signs of dysentery within 24 – 36 hours of challenge. Only two of the eight Travelan-treated group displayed any signs of dysentery. The remaining 6 of 8 (75%) of the Travelan-treated group remained healthy and without signs of dysentery post challenge. Recently completed histopathological analysis, which provides a comprehensive view of the clinical disease and its effect on tissues of gut, revealed that all animals in the placebo-treated group displayed severe inflammation in different parts of the gastrointestinal tract. These animals also had very high levels of inflammatory cytokines (IL-1b, IL-6 and IL-8) in fecal samples collected throughout the study. The inflammation seen in the gastrointestinal tract and the increase in inflammatory cytokines in the feces were closely associated with the observed clinical outcomes of dysentery. Only 3 of the 8 Travelan-treated animals had signs of inflammation in the gastrointestinal tract, and only 2 of those had high levels of inflammatory cytokines in fecal samples. All other animals in the Travelan-treated group were clinically healthy and did not excrete any inflammatory cytokines. Overall the results suggest that Travelan is functionally cross-reactive and may have some prophylactic activity against Shigellosis.

“The latest results reported by our colleagues at 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 are very impressive indeed. The study results clearly demonstrated that animals with severe inflammation in the gastrointestinal tract and high inflammatory cytokines in fecal samples were associated with severe dysentery and that prophylactic administration of Travelan significantly reduced the inflammatory response,”

The abstract of the study findings has been submitted for presentation at the 10 International conference on Vaccines for Enteric Diseases which will be held at the University of Lausanne Switzerland on the 16 to 18 October 2019.

“This is further validation of our technology platform,” “The work completed by our research collaborators at the WRAIR has clearly demonstrated the effectiveness of Travelan and the Immuron technology platform in neutralizing pathogenic gastrointestinal bacterial infections and offers significant potential as a preventative treatment for US military personnel and civilians stationed or traveling in locations where such infections may be debilitating.”

The company is also pleased to report that it has completed the manufacture of three new specific therapeutic products which have been manufactured with proprietary vaccines developed by the WRAIR. Preliminary laboratory evaluation has indicated that all three products have generated a strong antibody response to the antigens used in the manufacturing campaign. The three products will be evaluated in preclinical models of shigellosis developed by the WRAIR.

“The WRAIR has been developing vaccines against for over a decade and the combination of our vaccine research and development efforts with Immuron’s oral immunotherapy platform make perfect sense. The WRAIR will fund the evaluation of the anti- specific activity of the new products including assessing their protective capacity in established small animal models which will be completed and reported throughout the remainder of this year,” .

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 (). A preventative treatment that protects against enteric diseases, specifically shigellosis, is a high priority objective for the US Army. 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.

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Globe Newswire: 12:00 GMT Wednesday 12th June 2019

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