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(12) United States Patent (10) Patent No.: US 9,072,776 B2 Kristiansen (45) Date of Patent: *Jul

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(12) United States Patent (10) Patent No.: US 9,072,776 B2 Kristiansen (45) Date of Patent: *Jul US009072776B2 (12) United States Patent (10) Patent No.: US 9,072,776 B2 Kristiansen (45) Date of Patent: *Jul. 7, 2015 (54) ANTI-CANCER COMBINATION TREATMENT 5,032,401 A 7, 1991 Jamas et al. AND KIT OF-PARTS 5,223,491 A 6/1993 Donzis 5,322,841 A 6/1994 Jamas et al. O O 5,397,773. A 3, 1995 Donzis (75) Inventor: Bjorn Kristiansen, Frederikstad (NO) 5.488,040 A 1/1996 Jamas et al. 5,504,079 A 4, 1996 Jamas et al. (73) Assignee: Glycanova AS, Gamle Fredrikstad (NO) 5,519,009 A 5/1996 Donzis 5,532,223. A 7/1996 Jamas et al. (*) Notice: Subject to any disclaimer, the term of this 5,576,015 A 1 1/1996 Donzis patent is extended or adjusted under 35 3. A SE As al U.S.C. 154(b) by 424 days. 5622,940. A 4/1997 Ostroff This patent is Subject to a terminal dis- 33 A 28, AE" claimer. 5,663,324 A 9, 1997 James et al. 5,702,719 A 12/1997 Donzis (21) Appl. No.: 11/917,521 5,705,184. A 1/1998 Donzis 5,741,495 A 4, 1998 Jamas et al. (22) PCT Filed: Jun. 14, 2006 5,744,187 A 4/1998 Gaynor 5,756,318 A 5/1998 KOsuna 5,783,569 A 7/1998 Jamas et al. (86). PCT No.: PCT/DK2OO6/OOO339 5,811,542 A 9, 1998 Jamas et al. 5,817,643 A 10, 1998 Jamas et al. E. S 12, 2008 5,849,720 A 12/1998 Jamas et al. (2), (4) Date: ep. A 5,934,012 A 8, 1999 Holtz et al. 6,020,324. A 2/2000 Jamas et al. (87) PCT Pub. No.: WO2006/133707 6,084,092 A 7/2000 WakShullet al. 6,090,938 A 7/2000 WakShullet al. PCT Pub. Date: Dec. 21, 2006 6,110,692 A 8/2000 Wakshull et al. 6,117,850 A 9, 2000 Patchen et al. (65) Prior Publication Data 6,120,772 A 9, 2000 Ito et al. 6,143,731 A 11/2000 Jamas et al. US 2009/O143280 A1 Jun. 4, 2009 6,294,321 B1 9/2001 Wakshull et al. 6,369,216 Bl 4/2002 Patchen et al. 64 13,715 B2 7/2002 Wakshull et al. Related U.S. Application Data 6,440,448 B1 8/2002 Intelisano (60) Provisional application No. 60/690,482, filed on Jun. 6,630,310 B1 102003 Wakshullet al. 15, 2005, provisional application No. 60/761,743, 6,692,739 B1 2/2004 Patti et al. filed on Jan. 25, 2006. (Continued) (30) Foreign Application Priority Data FOREIGN PATENT DOCUMENTS Jun. 15, 2005 (DK) ................................. 2005 OO882 CN 1082551 ck 2, 1994 Jan. 25, 2006 (DK) ................................. 2006 00116 CN 1093714 10, 1994 (Continued) (51) Int. Cl. AOIN 65/00 (2009.01) OTHER PUBLICATIONS AOIN 43/04 (2006.01) A6 IK3I/70 (2006.01) EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); A6 IK 45/06 (2006.01) Scientific Opinion on the safety of "Lentinus edodes extract” as a (52) U.S. Cl. Novel Food ingredient. EFSA Journal 2010; 8(7): 1685.* CPC ................. A61K 45/06 (2013.01); A61 K3I/70 (Continued) (2013.01) (58) Field of Classification Search CPC ... A61 K31/70; A61K 45/06; A61K 2300/00 See application file for complete search history. Pririmary Examiner — DougOug SchultSchullZ (74) Attorney, Agent, or Firm — Posternak Blankstein & (56) References Cited Lund LLP U.S. PATENT DOCUMENTS (57) ABSTRACT 3,943,247 A 3, 1976 Komatsu R. A ck 1918. Sas al 424,116 In one aspect the present invention relates to pharmaceutical 4.174.388 A 1/1979 McAleer et al." kits of parts Suitable for treating neoplastic diseases such as 4,247,541 A 1/1981 Ishida et al. cancer comprising an anti-cancer medicament, a Basidi 4454,289 A 6/1984 Nakajima et al. omycete bioactive agent in Solid or liquid form, and, option ;439 A 68. SE etal ally instructions for a dosing regime. 4.769,363 A 5/1988 Misaki et al. 4,851,395 A 7, 1989 Ueno et al. 4,962,094. A 10, 1990 Jamas et al. 10 Claims, 2 Drawing Sheets US 9,072,776 B2 Page 2 (56) References Cited Abstract: Liu et al., “Study on antitumor activity of Agaricus blazei”. Shipin Gongye Kenji (2001), 22(4), 10-11. U.S. PATENT DOCUMENTS Abstract: Osaki, Y. et al., Antimutagenic and bactericidal Substances in the fruit body of a Basidomycete Agaricus blazei, Jun. 17. 7,022,685 B2 4/2006 Patchen et al. Yakugaku Zasshi, vol. 114(5), pp. 342-50, 1994. 7,514,085 B2 * 4/2009 Kristiansen .............. 424, 19515 Aokiet al.: "Antibodies to HTVLVI and III in sera from two Japanese 7.682,615 B2 * 3/2010 Kristiansen .............. 424, 19515 2001/0051717 A1 12/2001 Wakshull et al. patients, one with possible pre-aids' The Lancet, Oct. 20, pp. 936 2002fO164317 A1 11/2002 Gorsek 937, 1984. 2002fO164773 A1 11, 2002 Wasser Aoki, "Lentinan'. Immune Modulation Agents and Their Mecha 2003/0208796 A1 1 1/2003 Song et al. nisms, Editors: Fenichel and Chirigos, Marcel Dekker, Inc. 1984, pp. 2003/0229068 A1* 12/2003 Huang et al. ............. 514,210.21 63-77. 2004/0001856 A1 1/2004 Jin et al. Borchers A. et al. Mushrooms, Tumors, and Immunity: An update. 2005, OO69989 A1 3/2005 Kim et al. Experimental Biology and Medicine, 229:393-406 (2004). 2005/O158258 A1 7, 2005 Fisher Brauer et al. Effects of Management on the Yield and High-Molecu 2005.0245480 A1 11, 2005 Ostroffetal. lar-weight Polysaccharide Content of Shiitake (Lentinus edodes) 2006, OO13825 A1 1/2006 Kristiansen Mushrooms. J Agric Food Chem 2002, pp. 5333-5337, vol. 50. 2008, OO63650 A1 3, 2008 Yan Budavari. The Merck Index an encyclopedia of chemicals, drugs and 2008. O103112 A1 5/2008 Magee et al. biologicals. 1996, p. 927, right-hand column. 2008. O108114 A1 5, 2008 Cox et al. 2008.0167268 A1 7, 2008 Yan Chang R. Functional properties of edible mushrooms. Nutrition 2009,0005340 A1 1/2009 Kristiansen ..................... 514/54 Reviews, vol. 54, No. 11. Nov. 1996: s91-s93. 2010, OO86647 A1 4/2010 Kristiansen Chihara et al., “Fractionation and Purification of the Polysaccharides with Marked Antituniour Activity, Especially Lentinan, from FOREIGN PATENT DOCUMENTS Lentinan edodes (Berk.) Sing. (an Edible Mushroom), Cancer Research 30, 2776-2781, Nov. 1970. CN 1093714 A1 10, 1994 Chihara et al.: "Antitumour Polysaccharide derived Chemically from CN 1269423 11, 2000 Natural Glucan (Pachyman)' Nature, vol. 225, pp. 943-944, Mar. 7, CN 1297994 6, 2001 1970. CN 1314417 9, 2001 Chihara, “The antitumor polysaccharide Lentinan: an overview'', pp. CN 1477130 2, 2004 1-16, in Aoki, et al.,eds. Manipulation of Host Defence Mechanisms, CN 1490016 4/2004 (Excerpta Medica 1981). CN 1528335 9, 2004 Elisashvili et al. Extracellular Polysaccharide Production by Culi CN 1765935 3, 2006 nary Medicinal Shiitake Mushroom Lentinus edodes (Berk.) EP O2926O1 11, 1988 Singer and Pleurotus (Fr.) P. Karst. Species Depending on Carbon EP O2987O6 1, 1989 EP O37O673 5, 1990 and Nitrogen Source. International Journal of Medicinal Mush EP 11556.23 11, 2001 rooms, 2004, pp. 165-172, vol. 6. GB 1335.13 9, 1973 Fan et al., “Production of polysaccharide by culinary-medicinal JP O1132315 5, 1989 mushroom Agaricus brasiliensis S. Wasser et al. LPB 03 JP O6172217 6, 1994 (Agaricomycetideae) in Submerged fermentation and its antitumor JP 717307O 7, 1995 effect”. International Journal of Medicinal Mushrooms, vol. 5, pp. JP 63296.662 12/1998 17-23, 2003. JP 11080206 3, 1999 Fan et al: "Effect of nutritional and environmental conditions on the JP 2001078714 3, 2001 production of exo-polysaccharide of Agaricus brasiliensis by Sub JP 2002060344 2, 2002 merged fermentation and its antitumor activity” LWT, vol. 40, Oct. JP 20043.00438 3, 2004 KR 470734 2, 2005 20, 2005, pp. 30-35. KR 2003097062 2, 2005 Fujii T. et al., “Isolation and characterization of a new antitumour SU 1244179 T 1986 polysaccharide, KS-2, extracted from culture mycelia of Lentinus WO WO 89.12106 12/1989 edodes'. The Journal of Antibiotics. vol. 31, No. 11, pp. 1079-1090. WO WO9106307 5, 1991 Fujimiya et al., Selective Tumoricial effect of soluble proteoglucan WO WO 96.15659 5, 1996 extracted from the basidiomycete, Agaricus blazei Murill, mediated WO WOOO32212 6, 2000 via natural killer cell activation and apoptosis, Cancer Immunol WO WOOO32213 6, 2000 Immunother (1998) 46: 147-159. WO WOOO54795 9, 2000 Fujimiya et al., Tumor-specific cytocidal and immunopotentiating WO WOOO65O29 11, 2000 effects of relatively low molecular weight products derived from the WO WOO127305 4/2001 basidiomycete, Agaricus blazei Murill. Anticancer Res. Jan.-Feb. WO WOO151070 T 2001 WO WOO164057 9, 2001 1999; 19(1A): 113-8. WO WOO182935 11, 2001 Gonzaga et al., “Isolation and characterisation of polysaccharides WO WOO2O7708 1, 2002 from Agaricus blazei Murill', Carbohydrate polymers 2005, vol. 60, WO WO O2O876O3 11, 2002 Iss 1, p. 43-49. WO WO O2O98440 12/2002 Griffin et al., “Free lipids and carbohydrates of Agaricus bisporus WO WOO3O2O944 3, 2003 mycelium”. Biochem J. 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