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(12) Patent Application Publication (10) Pub. No.: US 2016/0015734 A1 KRISTIANSEN Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2016/0015734 A1 KRISTIANSEN Et Al US 2016.0015734A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2016/0015734 A1 KRISTIANSEN et al. (43) Pub. Date: Jan. 21, 2016 (54) BASDOMYCETE-DERVED CREAM FOR Publication Classification TREATMENT OF SKN DISEASES (51) Int. Cl. A613 L/76 (2006.01) (71) Applicant: GLYCANOVA AS, Gamle Frederikstad A647/44 (2006.01) (NO) A647/06 (2006.01) A647/10 (2006.01) (72) Inventors: Bjorn KRISTIANSEN, Frederikstad A619/00 (2006.01) (NO): Anne Torill HOVLAND, A6135/644 (2006.01) Borgenhaugen (NO) A647/26 (2006.01) A613 L/728 (2006.01) A69/06 (2006.01) A61E36/07 (2006.01) (73) Assignee: GLYCANOVA AS, Gamle Frederikstad A647/12 (2006.01) (NO) (52) U.S. Cl. CPC ... A61 K3I/716 (2013.01); A61K 36/07 (21) Appl. No.: 14/766,811 (2013.01); A61 K47/44 (2013.01); A61K47/06 (2013.01); A61 K47/10 (2013.01); A61K47/12 (22) PCT Fled: Feb. 10, 2014 (2013.01); A61 K35/644 (2013.01); A61 K 47/26 (2013.01); A61 K3I/728 (2013.01); (86) PCT NO.: PCT/B2O14/O58878 A61 K9/06 (2013.01); A61 K9/0014 (2013.01) S371 (c)(1), (57) ABSTRACT (2) Date: Aug. 10, 2015 The product according to the present invention is produced in a production process using the mycelium of a mushroom Such as Ganoderma lucidum. The production process encourages Related U.S. Application Data the growing mycelium to export bioactive compounds such as (60) Provisional application No. 61/763,014, filed on Feb. beta glucans into the Surrounding liquid. Thus, the beta glu 11, 2013. can is soluble and easily absorbed. More importantly, the production process allows the beta glucan to retain its triple (30) Foreign Application Priority Data helix structure which is required for maintain a very high bioactive efficacy. The beta glucans from Ganoderma luci Feb. 11, 2013 (DK) ........................... PA 2013 70070 dum can be used in a cream for treatment of psoriasis. Patent Application Publication Jan. 21, 2016 Sheet 1 of 25 US 2016/0015734 A1 Figure 1 A rtist's Stitt is sist SSSSSSSSSSSSSSSSSSSS SS asssssssssss s & S.S. Šs &% s's Patent Application Publication Jan. 21, 2016 Sheet 2 of 25 US 2016/0015734 A1 Figure 2A Limbs before treatment Limbs after 3 months treatment S Š : Patent Application Publication Jan. 21, 2016 Sheet 3 of 25 US 2016/0015734 A1 Figure2B Limbs before treatmen mbs after treatment Patent Application Publication Jan. 21, 2016 Sheet 4 of 25 US 2016/0015734 A1 Figure 3 A: Skin on human leg before treatment S SSŠ ------- $8 8& S S S S SY Š S S s S S S S S. S Patent Application Publication Jan. 21, 2016 Sheet 5 of 25 US 2016/0015734 A1 Figure 4 A) Patient BH : Right elbow pre and post treatment 8 Š B) Patient BH : Left elbow pre and post treatment & & &SS & y S. & 8. Six & 8 Š S Š8 8.&S Patent Application Publication Jan. 21, 2016 Sheet 6 of 25 US 2016/0015734 A1 Figure 4 continued C) Patient RA: Right elbow pre and post treatment & S S. Patent Application Publication Jan. 21, 2016 Sheet 7 of 25 US 2016/0015734 A1 Figure 4 continued E) Patient RA: Right knee pre and post treatment S & Patent Application Publication Jan. 21, 2016 Sheet 8 of 25 US 2016/0015734 A1 Figure 4 continued G) Patient JM: Right elbow pre and post treatment Patent Application Publication Jan. 21, 2016 Sheet 9 of 25 US 2016/0015734 A1 Figure 4 continued 1) Patient JM: Right elbow pre and 1 month post treatment SSS S& S.Š. Patent Application Publication Jan. 21, 2016 Sheet 10 of 25 US 2016/0015734 A1 Figure 4 continued K) Patient JM: Right calf pre and post treatment L) Patient Pl: Right elbow pre and post treatment Patent Application Publication Jan. 21, 2016 Sheet 11 of 25 US 2016/0015734 A1 Figure 4 continued M) Patient Pl: Left elbow pre and post treatment Š SŠ Š.S. Š S Patent Application Publication Jan. 21, 2016 Sheet 12 of 25 US 2016/0015734 A1 Figure 4 continued O) Patient JS: Left elbow pre and post treatment Patent Application Publication Jan. 21, 2016 Sheet 13 of 25 US 2016/0015734 A1 Figure 4 continued O) Patient NM: Left elbow pre and post treatment SS S S R) Patient GY: Elbows pre and post treatment Patent Application Publication Jan. 21, 2016 Sheet 14 of 25 US 2016/0015734 A1 Figure 4 continued S) Patient SG: Right elbow pre and post treatment Patent Application Publication Jan. 21, 2016 Sheet 15 of 25 US 2016/0015734 A1 Figure 4 continued U) Patient GO: Right elbow pre and post treatment S SS &S S$8 Š: . Š Patent Application Publication Jan. 21, 2016 Sheet 16 of 25 US 2016/0015734 A1 Figure 4 continued X) Patient PK: Right knee pre and post treatment Patent Application Publication Jan. 21, 2016 Sheet 17 of 25 US 2016/0015734 A1 Figure 4 continued Y) Patient PK: Left knee pre and post treatment % % Patent Application Publication Jan. 21, 2016 Sheet 18 of 25 US 2016/0015734 A1 Figure 5 ------------- 8. S. issing 3, 25. 3, s 150 3,3 . Patent Application Publication US 2016/0015734 A1 ç************************************~~~~;~~~~*********************************** Figure 8 %|% Patent Application Publication Jan. 21, 2016 Sheet 20 of 25 US 2016/0015734 A1 Figure 9 Percent of total, scaling 4 weeks | | || || | ----------------------------------------------------------------------------------------------------------------------------------------- Figure 10 Percent of total, redress 4 Weeks ·········································································· Patent Application Publication Jan. 21, 2016 Sheet 21 of 25 US 2016/0015734 A1 Figure 11 2% 4. 8O. 8% Missing Recetic Figure 12 Percent of total after 2 and 4 weeks, scating & 2 WeekS 84 weeks 3C essesssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssss 25, S 2O, is $ S 5 60 8% O% Missing rection Patent Application Publication Jan. 21, 2016 Sheet 22 of 25 US 2016/0015734 A1 Figure 13 rt of totai after 2 arted a Yfeeks, redress Mean percent eduction at 2 and weeks Patent Application Publication Jan. 21, 2016 Sheet 23 of 25 US 2016/0015734 A1 Figure 15 20% % 6 88 O. : wissing % improvement Patent Application Publication Jan. 21, 2016 Sheet 24 of 25 US 2016/0015734 A1 Figure 17 - - Figure 18 General opinion, end of treatment Es Aire you satisfied with Ganodex : 8 Would you keto contine yith Ganodex : a joid you go back to the previous treatent? x rest kroy missing % Arisyers US 2016/0015734 A1 Jan. 21, 2016 BASIDOMYCETE-DERVED CREAM FOR 0007. In one embodiment, the polysaccharide according TREATMENT OF SKN DISEASES to the present invention has a molar ratio of galactose:man nose:glucose of 1:10 to 20:30 to 50, such as 1:12 to 18:35 to 0001 All patent and non-patent references cited in U.S. 45; for example 1:14 to 16:38 to 42, such as 1:about 15:about 61/763,014 as well as in this application are hereby incorpo 40, for example 1:15:40. In another embodiment the polysac rated by reference in their entirety. U.S. 61/763,014 is hereby charide according to the present invention has a molar ratio of also incorporated herein by reference in its entirety. galactose:mannose:glucose of 1:1 to 10:5 to 50 such as 1:2 to 8:5 to 15, such as 1:about 5:about 10. FIELD OF THE INVENTION 0008. In one embodiment, the polysaccharide according 0002 The product according to the present invention is to the present invention has a molar ratio of galactose:man produced in a production process using the mycelium of a nose:glucose of 1:2 to 20:5 to 25, such as 1:3 to 18:5 to 20; for mushroom like a Basidiomycete cell Such as Ganoderma example 1:4 to 16:5 to 15, such as 1:about 5:about 10, for lucidum. The production process encourages the growing example 1:5:10. In another embodiment the polysaccharide mycelium to export bioactive compounds Such as beta glu according to the present invention has a molar ratio of galac cans into the Surrounding liquid. Thus, the beta glucan is tose:mannose:glucose of 1:2 to 10:5 to 20 such as 1:4 to 6:8 to soluble and easily absorbed. More importantly, the produc 12, such as 1:about 4 to 6:about 8 to 12. tion process allows the beta glucan to retain its triple helix 0009. The present invention also relates to methods for structure which is required for maintain a very high bioactive treating a skin disease, Such as psoriasis and eczema with a efficacy. The beta glucans from Ganoderma lucidum can be skin cream comprising bioactive agents such as polysaccha used in a cream for treatment of one or more skin diseases rides like beta glucan derived from cells of the class Basidi including psoriasis and eczema. omycete, including Ganoderma Such as Ganoderma luci dum. 0010. There is also provided a method for enhancing a BACKGROUND therapeutic effect of a skin disease medicament in an indi 0003. The medicinal mushroom Ganoderma lucidum has vidual, said method comprising co-administering, simulta been used for alongtime in China to prevent and treat various neously or sequentially in any order, said skin disease medi human diseases such as bronchitis, hepatitis, hypertension, cament in an effective amount with a bioactive agent tumorigenic diseases, immunological disorders and as an according to the invention, such as a polysaccharide, or a ingredient in skin creams. Ancient Chinese medical scholars composition according to the invention, wherein said bioac Suggested that Ganoderma lucidum could strengthen body tive agent or composition, when administered to said indi resistance and consolidate the constitution of patients.
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