Research & Development at Probiomics Ltd
Probiomics is committed to conducting state-of-the-art probiotic research and development in order to be leaders in the probiotic industry.
Rationale for Our Commitment to Provision of High-Level Scientific and Clinical Data
As the market for probiotic-containing products has grown rapidly, the WHO and FAO met in 2001 to provide guidelines for standardisation of probiotics. In summary, they stated that probiotic microbes should be capable of surviving passage through the digestive tract and have the capability to proliferate, meaning they must: • be resistant to gastric juices (acid and bile)
• grow in the presence of bile as in the gut
• be able to colonise the human intestinal tract.
In order to be termed a “probiotic”, the WHO/FAO also decreed that the probiotic microbe must be able to confer defined health benefits based on clinical data on the specific strain. WHO pointed out that not all probiotics are capable of meeting the criteria – therefore it is essential to define the specific strain used in trials.
Probiotic criteria
In general, it is agreed that the selection criteria for a lactic acid bacterium to be cited as ‘probiotic’ should include that it :
• be of human origin and non-pathogenic;
• withstand incorporation into a delivery vehicle at high cell counts, and
• remain viable throughout the shelf-life of the product;
• withstand transit through the gastrointestinal tract, that is, show acid and bile tolerance;
• be able to adhere to cells of the intestinal epithelium and/or colonize the lumen of the tract;
• show antagonistic activity towards enteric pathogens and/or
• provide demonstrated health benefits in humans.
PCC® Properties
Probiomics' unique proprietary novel strain of Lactobacillus fermentum, PCC®, has been isolated and characterised in accordance with the WHO/FAO guidelines. PCC® has the following demonstrated scientific and clinical properties:
• Isolated from a human sample using stringent selection criteria
• Identified as L. fermentum by carbohydrate and genetic typing
• Colonises the intestinal tract - esp. Peyer’s Patches. Adheres preferentially to human tissue
• Resists degradation by bile acids and pepsin
• Exhibits superior survival in acid (pH 2-4) environment
• Viable in nutrient limited conditions
• Stable through product processing
• Stable at room temperature
• Inhibits growth and adhesion of a broad range of human gastrointestinal pathogens
• Relieves symptoms of Irritable Bowel Syndrome
• Reduces incidence of respiratory infectionsin infants and adults
• Reduces symptoms of moderate to severe atopic dermatitis in infants and children
• Has an excellent safety profile
Probiomics' R&D Program
The Company's R&D effort is focussed on the following areas:
1. Clinical trials.Carefully conducted double-blind, placebo-controlled studies to document the individual efficacy of our specific PCC® organism for each potential clinical application. In particular, studies in intestinal (inflammatory bowel disease), skin (psoriasis), inflammatory (arthritis) and infectious (otitis media) disorders are planned or currently being conducted.
2. Product development. Opportunities exist to develop novel OTC and functional foods containing PCC®. Our scientists are committed to developing new probiotic formulations and new products containing PCC® which can make health claims based on robust clinical and scientific data.
The Company's pursuit of these objectives thus positions Probiomics Ltd at the forefront of the therapeutic probiotic industry. To achieve these objectives, the Company has formed a Scientific and Medical Advisory Board.
Scientific and Medical Advisory Board
In May, 2004, the Company appointed two distinguished clinicians to form the inaugural Scientific and Medical Advisory Board - Professor Ron Penny, AO, and Professor Terry Bolin. Both Professor Bolin and Professor Penny are internationally renowned clinicians and researchers in their respective areas of gastroenterology and clinical immunology, the two areas in which Probiomics is developing and commercialising health products.
Professor Ron Penny AO, DSc, MD, BS, FRACP, FRCPA is one of Australia’s leading immunologists, and is currently Emeritus Professor of Medicine – UNSW, Senior Clinical Advisor - NSW Health, medical Director of Good Health Solutions, and past Chairman of the NSW Blood Products Advisory Committee ,Justice Health Board the NSW SARS Task Force, and past member of the Ministerial Advisory Council on Medical and Health Research. He co-chairs the NSW Chronic, Aged and Community Health Taskforce. He is newly appointed Commissioner of the National Health and Hospital reform Commission. He has published over 350 medical and scientific papers in national and international journals.
Professor Terry Bolin MD(NSW) BS(Syd) FRACP FRCP(Lond) FRCP(Edin) DCH(Lond), is a gastroenterologist, Associate Professor of Medicine at the University of New South Wales, Visiting Physician to the Gastrointestinal Unit at The Prince of Wales Hospital, Sydney, and President of the Gut Foundation. He has published over 100 medical and scientific papers in national and international journals, particularly in the areas of infection and nutrition in developing countries. His other major interests relate to bowel disorders irritable bowel, Colitis and Crohn's disease and prevention of bowel cancer.
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