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(12) STANDARD PATENT (11) Application No. AU 2012306078 B2 (19) AUSTRALIAN PATENT OFFICE

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(12) STANDARD PATENT (11) Application No. AU 2012306078 B2 (19) AUSTRALIAN PATENT OFFICE (12) STANDARD PATENT (11) Application No. AU 2012306078 B2 (19) AUSTRALIAN PATENT OFFICE (54) Title Products and methods (51) International Patent Classification(s) A23L 33/10 (2016.01) A61K 36/06 (2006.01) A61K 8/99 (2006.01) G01N 33/564 (2006.01) (21) Application No: 2012306078 (22) Date of Filing: 2012.09.06 (87) WIPO No: W013/034911 (30) Priority Data (31) Number (32) Date (33) Country 1115417.6 2011.09.06 GB (43) Publication Date: 2013.03.14 (44) Accepted Journal Date: 2016.03.31 (71) Applicant(s) IP Science Limited (72) Inventor(s) Petyaev, Ivan (74) Agent / Attorney Pizzeys Patent and Trade Mark Attorneys Pty Ltd, GPO Box 1374, BRISBANE, QLD, 4001 (56) Related Art WO 2008/020260 A2 CHENG. C. et al: Journal of Agricultural and Food Chemistry (August 2011), Vol.59, pp.9950-9957 JP 2003-144090 A LIN, C. et al: Journal of the Science of Food and Agriculture (March 2011) Vol.91, pp. 1751-1758 WO 1999/023996 A2 WO 2008/035371 A2 WO 2002/089604 A2 (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date W O 2013/034911 Al 14 March 2013 (14.03.2013) W I PO I P CT (51) International Patent Classification: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, A23L 1/30 (2006.01) G01N33/564 (2006.01) BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, A23L 1/38 (2006.01) A61K36/06 (2006.01) DO, DZ, EC, EE, EG, ES, Fl, GB, GD, GE, GH, GM, GT, A61K 8/99 (2006.01) HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, (21) International Application Number: ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, PCT/GB2012/052192 NO, NZ, OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, (22) International Filing Date: SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, 6 September 2012 (06.09.2012) TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, Zw. (25) Filing Language: English (84) Designated States (unless otherwise indicated,for every (26) Publication Language: English kind of regional protection available): ARIPO (BW, GH, (30) Priority Data: GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, 1115417.6 6 September 2011 (06.09.2011) GB UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, (71) Applicant (for all designated States except US): IP SCI- EE, ES, Fl, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, ENCE LIMITED [GB/GB]; 2nd Floor, The Platinum MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, Building St John's Innovation Park, Cowley Road, Cam- TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, bridge CB5 ODS (GB). ML, MR, NE, SN, TD, TG). (72) Inventor; and Published: (75) Inventor/Applicant (for US only): PETYAEV, Ivan - with internationalsearch report (Art. 21(3 [GB/GB]; IP Science Limited, Browning House, 3 Tun wells Lane, Great Shelford, Cambridge CB22 5LJ (GB). before the expiration of the time limit for amending the claims and to be republished in the event of receipt of (74) Agent: POWER, David; 14 South Square, Gray's Inn, amendments (Rule 48.2(h London, Greater London WC 1 R 5JJ (GB). (81) Designated States (unless otherwise indicated,for every kind of nationalprotection available): AE, AG, AL, AM, (54) Title: PRODUCTS AND METHODS (57) Abstract: The invention relates to fungal cells and spores, as well as extracts of either, for use,in particular, in prevention or treatment of Chlamydia, or Helicobacterpylori or other infections, inflammation, inflammatory, lysosomal, acidic, SOD- or IgG or other immunoglobulin - peroxidases or hydrogen peroxide induced or other forms of oxidative damage, atherosclerosis, heart dis CA ease, stomach, intestinal and liver inflammatory conditions and their complications, promoting or stimulating regeneration or healing of wounds, burns, ulcers, or other forms of damaged or aged tissues, or in reducing elevated cholesterol and/or triglycerides levels In a preferred instance, the fungal cells or spores are those used in the manufacture of fungal fermented cheeses or other food stuff or beverages, particular fungal blue or white cheeses. WO 2013/034911 PCT/GB2012/052192 1 PRODUCTS AND METHODS TECHNICAL FIELD OF THE INVENTION The present invention relates to nutritional, cosmetic, preventive and therapeutic 5 applications of food fungi, fermentation products and extracts thereof. The invention relates in particular to lowering elevated cholesterol and/or triglycerides levels, as well as to treating or preventing infection, inflammation, inflammatory damage, atherosclerosis, heart disease, stomach, intestinal and liver inflammatory conditions and their complications, and to promoting or stimulating regeneration or healing of wounds, 10 bums, ulcers, or other forms of damaged or aged tissues. BACKGROUND OF THE INVENTION Chronic inflammatory processes in the liver and adipose tissues result in lipid abnormalities and Metabolic Syndromes. Chronic inflammation in other tissues also has 15 a number of clinical implications including atherosclerosis, cardio-vascular disease, obesity, diabetes type 2, cancer, sarcopenia, gastritis, stomach or duodenum ulcers, arthritis, dermatological diseases and aging of skin and other organs. There are a number of reports associating the development of those conditions with the presence of Chlamydia infection. Mechanisms for how Chlamydia infection can reach the liver, 20 alter lipid metabolism and trigger oxidative cascades have recently been reported [5-10]. Cytokines and in particular interleukins, lymphokines, and interferons are important in controlling inflammatory reactions and the infection process. 25 Inflammatory oxidative damage can result from bacterial infection, or autoantibodies, or the presence of other toxic factors, or when inflammation reaches a critical level. Damage to the cell membrane can result in the release of cell contents into the extracellular environment. The cell contents can include proteases, other degradation enzymes and acidic intracellular components. The release of the cellular contents into 30 the extracellular environment can result in further damage to cell membranes and the intracellular matrix. Moreover, the acidic shift in local pH can alter the peroxidase WO 2013/034911 PCT/GB2012/052192 2 activity of superoxide dismutases and other proteins with similar structural and catalytic properties [3-4]. Conditions involving inflammation and inflammatory damage are of ever increasing 5 importance. Levels of heart disease and diabetes are steadily increasing, driven, in part by high levels of obesity. SUMMARY OF INVENTION The inventors have discovered that food fungi and their fermentation products have a 10 range of previously uncharacterized and beneficial biological properties, including anti infective, anti-inflammatory, and anti-oxidative properties, as well as being able to stimulate tissue regeneration. The effect is seen in particular with fungi used in the production of blue and white fungal fermented cheese or other foodstuffs using such fungi. 15 Compositions described herein may, for example, reduce or inhibit infection, inflammation or oxidation, including inflammatory oxidative damage, in the individual or reduce or inhibit the onset, duration or severity of one or more symptoms associated with infection, inflammation or oxidation in the individual or reduce the risk of the 20 individual suffering from infection, inflammation or oxidation or one or more symptoms associated therewith. The compositions may be used to lower cholesterol and hence help reduce the incidence, or delay the onset of, heart disease, as well as helping promote recovery in heart disease, particularly after a heart attack. The invention may be used in particular to lower elevated cholesterol levels and/or triglyceride levels in an 25 individual. In one preferred instance, the invention may be used to lower or reduce cholesteterol and/or triglycerides and in particular to lower elevated cholesterol and/or triglycerides levels, including in subjects known to have atherosclerosis and/or heart disease, but also 30 healthy subjects. Given cheese is perceived as a high fat food, such a finding is unexpected. The compositions and methods of the invention may also be used to prevent, reduce or treat infection. WO 2013/034911 PCT/GB2012/052192 3 Hence, the invention provides for use in prevention or treatment of infection, inflammation, inflammatory damage, oxidative damage, atherosclerosis, heart disease, a stomach, intestinal or liver inflammatory condition or complication thereof, promoting 5 or stimulating regeneration or healing or in reducing elevated cholesterol and/or triglycerides levels. Accordingly, the present invention provides a composition comprising: (i) a population of cells and/or spores of a food fungus; 10 (ii) a food matrix comprising a population of cells and/or spores of a food fungus; and/or (iii) an extract, fermentation product or metabolite of (i) or (ii), for use in the prevention or treatment of infection, inflammation, inflammatory damage, oxidative damage, atherosclerosis, heart disease, a stomach, intestinal or liver 15 inflammatory condition or complication thereof, promoting or stimulating regeneration or healing or in reducing elevated cholesterol and/or triglycerides levels. The invention further provides for use of a composition comprising: (i) a population of cells and/or spores of a food fungus; (ii) a food matrix comprising a population of cells 20 and/or spores of a food fungus;
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