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(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 2 2 May 2009 (22.05.2009) (51) PCT (10) International Publication Number W O 2009/063221 A3 (74) Agent: FRANK B . DEHN & CO.; S t Bride's House, 10 Salisbury (81) Square, London EC4Y 8JD (GB). (21) International Patent Classification: A61K 31/716 (2006.01) A61K 38/02 (2006.01) A61K 36/06 (2006.01) A61P 1/00 (2006.01) A61K 36/28 (2006.01) A61P 31/00 (2006.01) International Application Number: PCT/GB2008/003850 Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, 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, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW (22) International Filing Date: 13 November 2008 (13.1 1.2008) English English GB GB GB (25) Filing Language: (26) Publication Language: (30) Priority Data: 0722283 .9 0809339.5 0819010.0 (71) 13 November 2007 (13.1 1 .2007) 2 2 May 2008 (22.05.2008) 1 6 October 2008 (16.10.2008) Applicant (for all designated States except US): BIOTEC PHARMACON ASA [NO/NO]; Strandgata 3 , N-9008 Tromso (NO). (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), Euro (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, e sepean c a FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MT, NL, NO, PL, PT, RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG). (71) Applicant (for BB only): GARDNER, Rebecca, Katherine [GB/GB]; Frank B . Dehn & Co., St. Bride's House, 10 Salisbury Square, London EC4Y 8JD (GB). (72) Inventors; and (75) Inventors/Applicants (for US only): JOHANSEN, Finn, Erik [NO/NO]; Skjoldveien 9C, N-0881 Oslo (NO). SANDVIK, Anders [NO/NO]; Kjelsasveien 53C, N-OsIo (NO). ENGSTAD, Rolf, Einar [NO/NO]; Sørliveien 16, N-9018 Tromsø (NO). Published: — with international search report — before the expiration of the time limit for amending the claims and to be republished in the event o receipt of f amendments [Continued on next page] (54) Title: METHODS O F TREATING O R PREVENTING INFLAMMATORY DISEASES O F THE INTESTINAL TRACT B Mesenteric lymph node (57) Abstract: The present invention relates t o a glucan derived from yeast having a beta- (1, 3 ) -backbone with one o r more beta- (1, 3 ) -side chains linked thereto for use i n the treatment o r prevention o f inflammatory bowel disease and related diseases o f abnormal bowel function i n a n animal, i n particular t o such uses employing a soluble glucan, e.g. from Saccharomyces cerevisiae, preferably when administered orally. The invention also relates t o alternative treatments o f inflammatory bowel disease and related diseases o f abnormal bowel function utilising meal o r protein derived from Asteraceae. (88) Date of publication of the international search report: 2 July 2009 INTERNATIONAL A . CLASSIFICATION OF SUBJECT MATTER SEARCH REPORT A61K36/28 International application No PCT/GB2008/003850 A61K38/02 A6 I P 1/00 INV. A61K31/716 A61P31/00 A61K36/06 According to International Patent Classification (IPC) orto both national classification and IPC B . FIELDS SEARCHED Minimum documentation searched (classification system followed by classification symbols) A61K A61P Documentation searched other than minimum documentation t o the extent that such documents are included i n the fields searched Electronic data base consulted d uπng the international search (name of data base and, where practical, search terms used) EPO-Internal , WPI Data, EMBASE, BIOSIS C . DOCUMENTS CONSIDERED T O B E RELEVANT Category* Citation of document, with indication, where approp πate, of the relevant passages Relevant t o claim No W O 2004/112802 A (EN BIO TECHNOLOGY C O LTD [KR]; MOON WON KOOK [KR]; KIM DONG WOO [KR];) 2 9 December 2004 (2004-12-29) page 1 , paragraph 1 page paragraph 7-9 page paragraph 13 - page 7 , paragraph 45 page 7 , paragraph 4 3 claims 1-7 W O 98/26787 A (UNIV NEW SOUTH WALES [AU]; COMMW SCIENT IND RES ORG [AU]; ARNOTT S BIS) 2 5 June 1998 (1998-06-25) page 2 , lines 4-12 page 3 , line 2 0 - page 4 , line 2 page 4 , line 2 5 - page 5 , line 2 page 14, line 1 - page 15, line 2 0 -/- 1-12, 17-21 1-12, 17-21 Further documents are listed in the continuation o f Box C * See patent family annex 'T' later document published after the international filing date o r priority date and not i n conflict with the application but cited t o understand the principle o r theory underlying the invention 1 document of particular relevance, the claimed invention X cannot be considered novel o r cannot be considered to involve a n inventive step when the document is taken alone "Y" document of particular relevance, the claimed invention cannot be considered t o involve a n inventive step when the document is combined with one o r more other such docu¬ ments such combination being obvious to a person skilled in the art "S" document member of the same patent family Date of mailing of the international search report Special categories of cited documents 'A' document defining the general state o f the art which is not considered t o be of particular relevance 1E' earlier document but published o n o r after the international filing date L1 document which may throw doubts o n priority cla ιm(s) o r which is cited to establish the publication date of another citation o r other special reason (as specified) 'O' document referring to a n oral disclosure use, exhibition o r other means 'P' document published prior to the international filing date but later than the priority date claimed Date of the actual completion of the international search 2 2 Apri l 2009 Name and mailing address of the ISA/ European Patent Office, P B 5818 Patentlaan 2 N L - 2280 HV Rijswijk TeI (+31-70) 340-2040, Fax (+31-70) 340-3016 Form PCT/ISA/210 (second sheet) (April 2005) 12/05/2009 Authorized officer TuI l berg, Erik International application No PCT/GB2008/003850 C(Continuatlon). Category * DOCUMENTS CONSIDERED TO BE RELEVANT Relevant to claim N o Citation of document, with Indication, where appropriate, of the relevant passages X E P 1 602 377 A (AUREO CO LTD [JP]) 7 December 2005 (2005-12-07) page 1 , paragraph 1 page 6 , paragraph 45-48 c l aims 1-6 1-12, 17-21 X DATABASE WPI Week 198633 Thomson Scientific, London, GB; A N 1986-215130 XP002514809 & J P 6 1 146192 A (SHINOHARA S ) 3 July 1986 ( 1986-07-03) abstract DATABASE WPI Week 200466 Thomson Scientific, London , GB; A N 2004-677018 XP002355008 & J P 2004 269407 A (AUREO KK) 3 0 September 2004 (2004-09-30) abstract 1-12, 17-21 X 1-12 , 17-21 X DATABASE WPI Week 200421 Thomson Scientific, London , GB; A N 2004-222364 XP002514813 & K R 2003 087 383 A (KANG S M) 14 November 2003 (2003-11-14) abstract E P 1 393 734 A (AJINOMOTO K K [JP] ) 1-12, 17-21 Y 3 March 2004 (2004-03-03) column 1 , paragraph 1 col umn 3 , paragraph 9-14 column 4 , paragraph 20 examples 1 , 2 column 7 , paragraph 29-31 1-12, 17-21 Y WO 2005/094234 A (FREEDOM HEALTH LLC [US]; BEDDING PETER M J [GB] ; PELLEGRINI L ) 13 October 2005 (2005-10-13) paragraph 26 14, paragraphs 30,31 paragraph 8 4 - page 37, paragraph 1-12 , 17-21 FRANKLIN page 10, pages 13, page 35, 88 Y 2007/076534 A (HILLS PET NUTRITION INC [US]; KHOO CHRISTINA [US] ) 5 July 2007 (2007-07-05) c l aims 1 , 1 1 , 1 4 WO 1-12, 17-21 -/-- Form PCT/ISA/210 (continuation ol second sheet) (April 2005) INTERNATIONAL C(Continuatlon). Category SEARCH REPORT International application N o PCT/GB2008/003850 DOCUMENTS CONSIDERED TO BE RELEVANT Relevant t o claim N o Citation o f document, with indication, where appropriate, o f the relevant passages A 1 389 466 A (AJINOMOTO K K [JP]) 18 February 2004 (2004-02-18) page 1 , paragraph 1 page 4 , paragraphs 9 , 12, 13 page 6 , paragraph 36 EP 1-12, 17-21 A "Effects o f pleuran (beta-glucan i sol ated from Pleurotus ostreatus) o n experimental col iti s i n rats" PHYSIOLOGICAL RESEARCH, ACADEMIA, PRAGUE , CZ, vol . 50, no. 6 , 1 December 2001 (2001-12-01) , pages 575-581 , XP002367629 ISSN: 0862-8408 the whole document AL: "Medicinal importance of beta-(l->3) , ( l->6)-gl ucans" MYCOLOGICAL RESEARCH, ELSEVIER, GB, vol . Ill , no. 6 , 1 June 2007 (2007-06-01 pages 635-652, XP022163026 ISSN: 0953-7562 the whole document CHEN ET NOSALOVA V ET AL: 1-12, 17-21 A fungal 1-12, 17-21 ), A CHIBA MITSURO ET AL: "Elevated p l asma ( l->3)-beta-D-g1ucan , a fungal cel l wal l constituent, i n a subgroup o f Crohn d i sease" SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY , XX, XX, vol . 36, no. 4 , 1 Apri l 2001 (2001-04-01 ) , pages 447-448, XP009112017 ISSN: 0036-5521 the whole document U S 2006/205679 A l (STREEPER ROBERT [US] AL) 14 September 2006 (2006-09-14) the whole document WO 1-12, 17-21 A ET 1-12, 17-21 Y 02/100189 A (MARS UK LTD [GB] ; BUTTERWICK RICHARD FULTON [GB] ; ROLFE 13-21 VIVIEN ELIZABE) 19 December 2002 (2002-12-19) page 7 , l ines 27,28 c l aims 14-22 page 5 , l ines 1-18 -/ ~ Form PCT/ISA/210 (continuation o f second sheet) (April 2005) INTERNATIONAL SEARCH REPORT C(Contln_ation). Category * DOCUMENTS CONSIDERED TO B E RELEVANT International application No PCT/GB2008/003850 Citation ot document, with indication, where approp π ate, of the relevant passages Relevant to claim N o FUJITA T ET AL: "EFFICACY O F GLUTAMINE-ENRICHED ENTERAL NUTRITION IN A N EXPERIMENTAL MODEL O F MUCOSAL ULCERATIVE COLITIS" BRITISH JOURNAL O F SURGERY, JOHN WRIGHT & SONS, BRISTOL, GB, vol . 82, no. 6 , 1 January 1995 (1995-01-01), pages 749-751, XP008008002 ISSN: 0007-1323 abstract page 750, right-hand column, line 1 - page 751, left-hand column, line 2 2 W O 99/45797 A (MARS INC [US]; CHEVAUX KATI A [US]; SCHMITZ HAROLD H [US]; ROMANCZYK L ) 16 September 1999 (1999-09-16) page 5 , lines 15-26 page 7 , lines 1-7 page 18, lines 8-21 example 10 W O 00/53205 A (EIJSSELSTEIJN DANNY VAN [NL]; EEUWIJK WOUTER PAULUS VAN [NL]; DOST ANI) 14 September 2000 (2000-09-14) the whole document DATABASE WPI Week 200566 Thomson Scientific, London, GB; A N 2005-646256 ' XP002524640 & R U 2 259 781 C l (CHERKIZOVSK MEAT PROCESSING WKS STOCK CO) 10 September 2005 (2005-09-10) abstract SOBHAGINI NAYAK ET AL: "Ethno-medico-botanical survey o f Kalahandi district of Orissa" 20040101, vol . 3 , no. 1 , 1 January 2004 (2004-01-01), pages 72-79, XP018000014 the whole document KOUSHIK MAJUMDAR 1 ET AL: "Medicinal plants prescribed by different tribal and non-tribal medicine men o f Tripura state" INDIAN JOURNAL O F TRADITIONAL KNOWLEDGE, RESOURCES, NEW DELHI, vol . 5 , no. 4 , 1 October 2006 (2006-10-01), pages 559-562, XP018021470 ISSN: 0972-5938 the whole document 13-21 13-21 13-21 13-21 13-21 13-21 -/-Form PCT/ISA/210 (continuation of second sheet) (April 2005) INTERNATIONAL SEARCH REPORT C(Contlnuation). DOCUMENTS CONSIDERED TO BE RELEVANT International application No PCT/GB2008/003850 Category * Citation of document, with Indication, where appropriate, of the relevant passages Relevant t o claim No. MATHABE M C ET .AL: "Antibacterial activities o f medicinal plants used for the treatment o f diarrhoea i n Limpopo Province, South Africa" JOURNAL O F ETHNOPHARMACOLOGY, ELSEVIER SCIENTIFIC PUBLISHERS LTD, IE, pages 286-293, XP025085955 ISSN: 0378-8741 [retrieved o n 2006-04-21] the whole document vol. 105, no. 1-2, 2 1 April 2006 (2006-04-21), 13-21 Form PCT/ISA/210 (continuation of second sheet) (April 2005) INTERNATIONAL Box No. I l SEARCH REPORT International application No. PCT/GB2008/003850 Observations where certain claims were found unsearchable (Continuation of item 2 of first sheet) This international search report has not been established in respect of certain claims under Article 17(2)(a) for the following reasons: Claims Nos.: because they relate to subject matter not required to be searched by this Authority, namely: 2. I I Claims Nos.: because they relate to parts of the international application that do not comply with the prescribed requirements to such a n extent that no meaningful international search can be carried out, specifically: Clams Nos.: because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a). Box No. Ill Observations where unity of invention is lacking (Continuation of item 3 of first sheet) This International Searching Authority found multiple inventions in this international application, as follows: see additional sheet 1. y A s all required additional search fees were timely paid by the applicant, this international search report covers allsearchable 2. A s all searchable claims could b e searched without effort justifying an additional fees, this Authority did not invite payment of additional fees. 3. I I A s only some of the required additional search fees were timely paid by the applicant, this international search reportcovers '— ' only those claims for which fees were paid, specifically claims Nos.: 4. No required additional search fees were timely paid by the applicant. Consequently, this international search report i s restricted to the invention first mentioned i n the claims; it is covered by claims Nos.: Remark o n Protest I The additional search fees were accompanied by the applicant's protest and, where applicable, the - I payment of a protest fee. I I The additional search fees were accompanied by the applicant's protest but the applicable protest I— 'fee was not paid within the time limit specified in the invitation. I X I No protest accompanied the payment of additional search fees. Form PCT/ISA/210 (continuation of first sheet (2)) (April 2005) INTERNATIONAL SEARCH REPORT International Application No. PCT/GB2008 /003850 FURTHER INFORMATION CONTINUED FROM PCT/ISA/ 2 10 Thi s Internati onal Searching Authority found multiple (groups of) i nventi ons i n thi s i nternati onal appl icati o n , a s fol l ows : 1 . claims: 1-12, (Part 17-21) A glucan derived from yeast according t o the subject-matter of claims 1-12 for use i n the treatment or prevention o f inflammatory bowel disease such a s ulcerative colitis or Crohn's disease and related diseases of abnormal bowel function i n a n animal such a s constipation diarrhoea, fecal incontinence and conditions and diseases resulting due t o surgical bowel resection. A kit containing said glucan according t o claim 2 0 and a product containing said glucan together with a second active ingredient for use according t o the subject-matter o f claim 21. 2. claims: 13-16, (part 17-21) Meal or protein derived from Asteracea for use i n the treatment o r prevention o f inflammatory bowel disease such a s ulcerative colitis or Crohn's disease and related diseases o f abnormal bowel function i n a n animal such a s constipation diarrhoea, fecal incontinence and conditions and diseases resulting due t o surgical bowel resection. A kit containing said meal o r protein according t o claim 2 0 and a product containing said meal or protein together with a second active ingredient for use according t o the subject-matter o f claim 21. I nternational application No Information o n patent family members PCT/GB2008/003850 Patent family member(s) Publication date Patent document cited in search report WO Publication date 2004112802 9826787 A A 29-12-2004 25-06-1998 NONE WO CA JP E P . 1602377 2275507 2001506129 1083590 2004078188 20050115854 282279 2005272694 1799898 5004063 4054697 Al T Al Al A B Al C B B2 25-06-1998 15-05-2001 14-03-2008 16-09-2004 08-12-2005 11-06-2007 08-12-2005 12-11-1993 19-01-1993 27-02-2008 A 07-12-2005 HK WO KR TW US J P 61146192 A 03-07-1986 JP JP JP NONE J P 2004269407 K R 2003087383 E P 1393734 A A A 30-09-2004 03-03-2004 WO US US WO 02098433 2006159698 2004138172 047308 2004317895 PI0418681 2559755 1729809 2007529220 20070006843 2006330421 2635038 101351124 1978821 354355 1505524 60218299 02087603 3633601 2004142000 Al Al Al Al Al A Al A2 12-12-2002 20-07-2006 15-07-2004 18-01-2006 13-10-2005 12-06-2007 13-10-2005 13-12-2006 25-10-2007 11-01-2007 05-07-2007 05-07-2007 21-01-2009 15-10-2008 15-03-2007 16-06-2004 31-10-2007 07-11-2002 30-03-2005 22-07-2004 2005094234 A 13-10-2005 AR AU BR CA EP JP KR WO T A Al Al A Al T A T2 Al B2 2007076534 A 05-07-2007 AU CA CN EP E P 1389466 A 18-02-2004 AT CN DE WO JP US Al U S 2006205679 WO Al A 14-09-2006 19-12-2002 NONE 02100189 AU EP GB US ZA WO 2918202 1395127 2378134 2005107303 200301169 372972 766673 3004199 9908721 2322860 1300189 69937105 1061816 A Al A Al A T B2 19-12-2002 10-03-2004 05-02-2003 19-05-2005 14-06-2004 15-09-2007 23-10-2003 27-09-1999 30-10-2001 16-09-1999 20-06-2001 05-06-2008 27-12-2000 9945797 A 16-09-1999 AT AU AU BR CA CN DE EP Form PCT/ISA/210 (patent family annex) (April 2005) A A Al A T2 Al International application No Information on patent family members PCT/GB2008/003850 Patent family member(s) Publication date Patent document cited i n search report Publication date WO 9945797 JP PL 2002505864 T 342857 A l 2580500 A 1161253 A l 1011529 C 2 26-02-2002 16-07-2001 28-09-2000 12-12-2001 12-09-2000 O 0053205 A 14-09-2000 AU EP NL R U 2259781 Cl 10-09-2005 NONE Form PCTΛSA/210 (patent family annex) (April 2006)