Patent SG-11201408481U-A (SG)
Title: Euglobulin-based method for determining the biological activity of defibrotide
Inventor: IGNONI TERENZIO
IPC: G01N33/48
Filed: 2012-06-22
Abstract: (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 27 December 2013 (27.12.2013) WIPOIPCT (10) International Publication Number WO 2013/190582 A1 (51) International Patent Classification: C12Q 1/37 (2006.01) G01N 33/48 (2006.01) C12Q 1/56 (2006.01) (21) International Application Number: PCT/IT2012/000193 (22) International Filing Date: (25) Filing Language: (26) Publication Language: 22 June 2012 (22.06.2012) English English (71) Applicant (for all designated States except US): GENTI­ UM S.P.A. [IT/IT]; Piazza XX Settembre, 2,1-22079 Villa Guardia (CO) (IT). (72) Inventors; and (75) Inventors/Applicants (for US only): IGNONI, Terenzio [IT/IT]; Via Verdi, 15, 1-22070 Solbiate (CO) (IT). KU­ MAR, Vijay [GB/IT]; Via Galilei, 4, 1-22070 Casnate (CO) (IT). ISLAM, Khalid [GB/IT]; Via San Gottardo, 80, CH-6900 Massagno (CH). (74) Agents: PISTOLESI, Roberto et al.; c/o Dragotti & Asso- ciati S.R.L., Via Nino Bixio, 7,1-20129 Milano (IT). (81) 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, CL, 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, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG). Declarations under Rule 4.17: — of inventorship (Rule 4.17(ivf) Published: — with international search report (Art. 21(3)) (54) Title: EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE Figure 1 CJ 00 © o\ i= 2 < 1 Defibrotide Human in Euglobulin j J 1 1 -U-V)'*-*' 1 + j... j 20 40 BO mill 100 - Human Euglohulin -Human Eu + Def 10 ug/mL Human Eu + Def ug/mL 5 - Human Eu + Q«f 50 ug/niL i-H o CJ O & (57) Abstract: It is disclosed method a for determining the biological activity of defibrotide, which comprises the steps of: a) bring­ ing into contact defibrotide, mammalian euglobulin and substrate a specific for the plasmin which, by reaction with the plasmin, provides a measurable product; and b) measuring the amount of product formed successive at times, to thereby determine the biolo - gical activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having defined a bio - logical activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27.5 to 32.5 IU/mg and, more preferably, from 28 to 32 IU/mg.