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1. 发明申请

US20170354651A1 Treatment Of Neurodegenerative Diseases With Combination Of Laquinimod And Fingolimod 审中-公开
公开(公告)号：US20170354651A1
公开(公告)日：2017-12-14
申请号：US15669748
申请日：2017-08-04
申请人： Michael Hayden , Liat Hayardeny , David Ladkani
发明人： Michael Hayden , Liat Hayardeny , David Ladkani
IPC分类号： A61K31/4704 , A61K9/00 , A61K31/137 , A61J1/03 , A61K47/18 , A61K47/02 , B65D81/26 , A61K47/26 , A61K9/28 , B65D1/02 , B65D65/38 , A61K9/14
CPC分类号： A61K31/4704 , A61J1/035 , A61K9/0053 , A61K9/14 , A61K9/2866 , A61K31/00 , A61K31/137 , A61K47/02 , A61K47/18 , A61K47/26 , A61P25/00 , A61P25/02 , A61P25/14 , A61P25/16 , A61P25/28 , B65D1/0215 , B65D65/38 , B65D81/266 , A61K2300/00
摘要： This invention provides a method of treating a subject afflicted with a neurodegenerative disease comprising periodic administration of an amount of laquinimod and an amount of fingolimod, wherein the amounts when taken together are effective to treat the subject. Also provided are packages and pharmaceutical compositions comprising laquinimod and fingolimod for treating a subject afflicted with a neurodegenerative disease. Also provided is a pharmaceutical composition comprising laquinimod for use as an add-on therapy or in combination with fingolimod, and a pharmaceutical composition comprising fingolimod for use as an add-on therapy or in combination with laquinimod, for treating said subject.

2. 发明申请

US20170003277A1 BIOLOGICAL CHARACTERIZATION OF A GLATIRAMER ACETATE RELATED DRUG PRODUCT USING MAMMALIAN AND HUMAN CELLS 审中-公开
标题翻译：使用马马里兰和人类细胞的乙酸银相关药物产品的生物学特性
公开(公告)号：US20170003277A1
公开(公告)日：2017-01-05
申请号：US14789833
申请日：2015-07-01
申请人： Michael Hayden , Fadi George Towfic , Sarah Elisabeth Kolitz , Benjamin James Zeskind , David Ladkani , Tal Hasson , Liat Hayardeny , Iris Grossman
发明人： Michael Hayden , Fadi George Towfic , Sarah Elisabeth Kolitz , Benjamin James Zeskind , David Ladkani , Tal Hasson , Liat Hayardeny , Iris Grossman
IPC分类号： G01N33/50 , A61K31/785 , G01N33/94
CPC分类号： G01N33/5023
摘要： The present invention provides a process for characterizing a glatiramer acetate related drug substance or drug product comprising the steps of: a) obtaining a batch of the glatiramer acetate related drug substance or drug product; b) contacting mammalian cells with an amount of the glatiramer acetate related drug substance or drug product of step a); and c) i) determining the level of expression of at least one gene selected from the group consisting of ABCF2, ABI2, ACP6, AFG3L2, ALMS1, ARPC4, CALM3, CCDC64, CD84, CDC6, CHAF1A, CLU, COX11, DLGAP1, DTX4, FAM49B, FHL1, FNTB, GYPC, HFE, IL10, LPHN1, NACA, OLAH, PATZ1, PDK1, POLI, REEP5, RPL5, RPS6KA2, SEC31A, SETBP1, SNRPA1, SYNCRIP, TNFSF9, TOMM40, TPM1, TSHZ1, TSPAN13, UBAP2, VAV3, VDAC2, and ZFAND6; ii) determining the level of expression of at least one gene selected from the group consisting of BIRC3, CCL24, CCR1, CISH, CSF1R, CX3CR1, CXCL10, HSPD1, ICAM1, IL1B, IFNGR1, IL27, IL2RG, IL7R, IL1RN, MMP1, MMP9, MMP14, PGRMC1, PRDM1, CARD15, CCL2, CCL5, CD14, IL10, THBD, and NFKBIA, wherein if IL1B, IL10, or MMP9 is the at least one gene selected in part (c)(ii), then selecting at least a second different gene from the group other than IL1B, IL10, or MMP9; iii) determining the level of expression of at least one gene selected from the group consisting of C13ORF31, C14ORF10, C1ORF51, C1ORF63, CBR4, CB36, CD9, COL6A1, DAB2, GATA2, KIAA0907, LOC100506233, MCM6, MMP1, MS4A4A, MTSS1, PCMTD1, STK4, STX7, TAF15, TARP, TIA1, TMF1, TRGC2, TXNDC11, and ZCCHC7, and ZCCHC7; iv) determining the level of expression of at least one gene selected from the group consisting of ANXA1, ARRB2, BEAN, BIN1, C1ORF63, CD44, CD9, CFP, COL6A1, CRIP2, EPB41, Fam119a, FGR, FOX03B, HSD11B1, HSPD1P6, LOC387790, MPEG1, MYB, OLIG1, PLD1, PPP4R2, PRDM1, RBM6, SNX27, 5OD2, STATH, TARP, TREM1, TRGC2, UBN2, and ZCCHC7; v) determining the level of expression of at least one gene selected from the group consisting of ADAM9, ADAMDEC1, AKR1C2, ANXA2, ANXA2P2, ARHGAP18, ARHGAP18, ARL6IP5, ARL6IP5, ATP2C1, BID, BIRC3, BTG1, CARD15, C1ORF21, C13ORF31, C5ORF13, C5ORF32, C9ORF130, CAST, CCL2, CCL5, CD14, CD300A, CD36, CD40, CD55, CD9, CENTA2, CHST11, COL6A1, CRYBB2, CXCL10, CYLD, DAB2, EBI3, EBI2, ECOP, EGF, FABP4, FXYD2, GHRL, GIMAP8, GLIPR1, G0S2, HMGB2, HNRPLL, ICAM1, ICAM2, IFIH1, IFNGR1, IL10, MORA, IL4I1, INADL, ISG20, ITGB5, KIAA1505, KYNU, LACTB, L0054103, LOC388344, LOC652751, LPAAT-THETA, LPXN, MAFB, MALT1, MFI2, MGC5618, MGLL, MITF, MLF1, MMPI, MMP9, MPEG1, MTSS1, MXD1, NT5E, NFKBIE, NFKBIA, NFE2L3, NFE2L3, OSBPL11, P2RX4, P2RY5, PLEKHO1, POPDC3, PLAUR, PRDM1, PSCDBP, PTX3, RAB27B, RCSD1, RPL13, SGIP1, SLC39A8, SNORD68, SRPX2, SRA1, SLIC1, SLAMF8, SLIC1, SOD2, STATH, STEAP1, SYNJ2, SYNJ2, TATDN3, TGM5, THBD, TNFAIP3, TNFAIP6, TNFRSF9, TNFSF13B, TPSAB1, TPSB2, TREM1, TXNL2, VPS33A, and VSNL1; vi) determining the level of expression of at least one gene selected from the group consisting of ACTN4, BTBD14A, C14ORF10, CISH, CLK1, CRLF3, FAM62A, FBX045, GAPDHS, HDAC4, HIC2, HNRPD, HSPD1, LOC648342, MYB, NAPB, OXCT2, SERPINB2, SFRS14, SPFH1, STT3B, WDFY1, ZNF250, and ZNF566; vii) determining the level of expression of at least one gene selected from the group consisting of A2M, ABCB1, ABCC3, ABHD2, ACPP, ADAMDEC1, ADFP, ADORA2B, ADORA3, AHNAK, ALCAM, ANKH, ANKRD57, ANXA2, ANXA2P2, APBB1IP, AQP1, ARHGAP18, ARHGAP20, ARHGEF3, ARID5B, ARMC9, ATF5, ATP1B1, ATP6V0D2, ATP9A, ATP10A, AYTL1, BCL2A1, BCL6, C3AR1, C13ORD31, C9ORF88, C9ORF89, C1ORF21, C1ORF21, C10ORF95, C13ORF31, C21ORF7, CARD12, CARD15, CCDC83, CCL5, CCL24, CCND1, CCR1, CD9, CD36, CD52, CD86, CD109, CD180, CD244, CDK5RAP2, CDKN1A, CENTA2, CKB, CKLF, CLEC7A, CNIH3, COL6A1, COL22A1, CRIP2, CSF1R, CSPG4, CTSL, CTSLL3, CX3CR1, CXCR7, CYBB, CYP1B1, DAB2, DAPP1, DDIT4L, DIXDC1, DOCK4, DOK2, DKFZP56400823, DKFZP686O1327, EBI2, EMP1, EMR2, ENPP2, EPAS1, EPS8, EPSTI1, EVL, FABP4, FADS3, FAM26B, FGD2, FGD2, FGD4, FGL2, FN1, FTH1, GBP2, GBP3, GBP5, GCNT1, GDPD1, GNDL, GNLY, GLIPR1, GLIS3, GPC1, GPR35, H2A/R, HAVCR2, HMCN1, HIPK2, HIST2H2AA, HIVEP1, HMOX1, HSPB7, ICAM1, ID2, ID2B, IFI30, IFI44, IFNGR1, IGFBP3, IL2RG, IL4I1, IL1ORA, IL27RA, IL7R, IL10, INA, IRF7, ITGB5, ITGB7, KIAA1505, KIAA1706, KMO, LBH, LFNG, LILRB1, LILRB2, LMNA, L0051334, LOC201895, LOC284262, L0051334, LOC643424, LOC643834, LOC643847, LOC644242, LOC645238, LOC650429, LOC650446, LOC652543, LOC653610, LOC653754, LPAAT-THETA, LPXN, MAF, MAFB, MAML2, MAML3, MARCH1, MCOLN3, MDGA1, ME1, MFI1, MFI2, MGC45491, MGLL, MITF, MMP1, MMP2, MMP9, MMP14, MMP19, MTMR11, MTSS1, MTSUl, NGEF, NME7, NPTX1, NRCAM, NRP1, NRP2, NT5E, OAS1, OLR1, P2RY5, P2RY14, PALLD, PAPSS2, PAQR5, PCDHGA1, PCDHGA2, PCDHGA3, PCDHGA4, PCDHGA5, PCDHGA6, PCDHGA7, PCDHGA8, PCDHGA9, PCDHGA10, PCDHGA11, PCDHGA12, PCDHGB1, PCDHGB2, PCDHGB3, PCDHGB4, PCDHGB5, PCDHGB7, PCDHGC3, PCDHGC4, PCDHGC5, PDK4, PDLIM7, PFKFB4, PGA5, PDLIM4, PHLDA1, PLA2G4A, PLEKHA7, PLEKHO1, POPDC3, PRDM1, PRSS23, PSCDBP, PSD3, PTAFR, PTGS1, PTPRO, PTRF, PTX3, RAB27B, RAB38, RAB7B, RAPH1, RASGRF1, RGL1, RGS13, RHBDF1, RIN2, S100A2, SART2, SERPINE2, SERTAD1, SETBP1, SGIP1, SH3TC1, SKIL, SLA, SLAMF7, SLAMF8, SLC6AS, SLC7A11, SLC12A6, SLC37A2, SLC41A2, SLC38A6, SLC43A2, SNAI3, ST3GAL5, STATH, STEAP1, SUCNR1, SYTL1, TBXAS1, TCF4, TFAP2A, THBD, TLR4, TM7SF4, TMEM39A, TMEM158, TNCRNA, TNFSF13B, TNFRSF21, TREM1, TRIM22, TRPA1, TRPM8, TRPS1, TUBB2A, UBXD5, UGCG, UPP1, VASH1, VEGF, VSNL1, and ZFP36L1; viii) determining the level of expression of at least one gene selected from the group consisting of ABCG1, ADAMTS1, ANKRD41, ANXA3, APCDD1, BCL2, BCL11A, BMP8B, C1ORF71, C1ORF76, ClORD121, C12ORF24, C16ORF73, C16ORF74, C20ORD27, C20ORF103, C20ORF112, CACNA2D3, CAMTA1, CAV1, CCDC85B, CDCA7L, CEBPD, CKAP4, CNTN4, COL8A2, CSPG5, CXCR4, DCUN1D4, DEPDC6, DMRT2, DUSP2, DZIP1, EBF3, EGR4, FAM117A, FKBP4, FL135848, FLOT2, GFI1, GMDS, GPR18, HAL, HNF4G, HSPC049, IL17D, IRX3, KBTBD11, KCNQ4, KCTD15, KIAA0146, KIAA0984, KIAA1026, KIAA1553, KLHL23, LGR4, LOC201164, LOC284454, LOC387763, LOC642083, LOC648232, MGC2408, MICAL1, MID1IP1, MSRB3, MUC19, NAPSB, NR1D2, PCDH8, PDE4B, PDGFD, PER2, PHF15, PKP2, PLK2, OAF, OSBPL1A, OSR2, OXCT2, PGM1, PMAIP1, PNMA6A, POU4F2, PSAT1, RAB33A, RASGRP2, RBM38, RET, RFTN1, SERPINB2, SERPINB10, SLAIN1, SLC1A3, SLC16A1, SLC19A1, SLC27A2, SLC29A1, SLC39A14, SLCO4A1, SNF1LK, SOX12, SPFH1, SPRY1, STEAP3, 5YDE2, SYNPO2, TARP, TEAD4, TDRD7, TMEM67, TPD52, TRGC2, TRGV2, TRGV9, TRIB3, TSPAN2, TUBA1, VIT, WDR49, WNT3, WT1, and YES1; ix) determining the level of expression of at least one gene selected from the group consisting of AHRR, CCDC36, CYP1B1, DOC1, EPB41L3, GAS7, GPR68, NPTX1, PDCD6, and TIPARP; x) determining the level of expression of at least one gene selected from the group consisting of ADRB2, COTL1, LOC285758, LOC644137, MALAT1, PRG1, RNF43, SAT1, THAP5, TIMP3, and TSC22D1; xi) determining the level of expression of at least one gene selected from the group consisting of AW011738, Bst2, Daxx, Gm16340, Hck, Herc6, Ifi202b, Ifi203, Ifi204, Ifi44, Ifi441, Ifit2, Inpp5b, LOC100044068, LOC100862473, Mx1, Oas11, Phf11d, Oyhin1, Sdc3, Setdb2, Tor3a, Usp18, and Zcchc2; xii) determining the level of expression of at least one gene selected from the group consisting of Ccdc711, D13ERTD608E, Fads2, Gm2a, Ifi2711, Ighm, Klk1, Scd2, Siglech, and Tspan2; xiii) determining the level of expression of at least one gene selected from the group consisting of Ahrr, AI607873, Atp10a, AW011738, Casp44, Cxc13, Gm9706, Ifi202b, Ifit2, Ifitm6, I118, Lcn2, LOC100044068, Ms4a6d, Mx1, Papd7, Rsad2, Slfn3, Slfn4, Tdrd7, Tiparp, and Zcchc2; xiv) determining the level of expression of at least one gene selected from the group consisting of Aldoc, Casp6, Ccdc711, Cox7a1, Egln3, Fam162a, Gfi1, Gpi1, Grhpr, Ifi2711, Ighm, Kcnq5, Klhdc2, Pgk1, Pkm, Tpi1, and Trappc6a; xv) determining the level of expression of at least one gene selected from the group consisting of 1600014C10Rik, 2810474O19Rik, 6720475J19Rik, Adam8, Adar, Agrn, Ahrr, AI607873, Amigo2, Ankfy1, Apobec1, Arf4, Asb2, Ascc3, Atp10a, Atp8b4, AW011738, B4galt5, BC147527, Bst2, Casp4, Chic1, Cmpk2, Csprs, Cxc13, Cybb, Daxx, Ddit3, Ddx24, Ddx58, Ddx60, Dpp4, Eif2ak2, Emr1, Epsti1, Evi2a, Fcgr1, Fcgr4, Ftsjd2, Gcnt1, Gm11772, Gm14446, Gm15433, Gm16340, Gm20559, Gm2666, Gm7609, Gm9706, Gpnmb, Gpr15, H2-T10, H2-T9, Hck, Helz2, Herc6, Hsh2d, Hspa1b, Ifi202b, Ifi203, Ifi204, Ifi205, Ifi2712a, Ifi35, Ifi44, Ifi441, Ifit1, Ifit1, Ifit2, Ifit3, Ifitm3, I118, I17r, Inpp5b, Ins16, Irf7, Isg20, Klrk1, Lga1s3bp, Lga1s9, LOC100041903, LOC100044068, LOC100503923, LOC100505160, LOC100862473, LOC664787, Lpar6, Ly6cl, Ly6c2, Mb21d1, Mitd1, Mlk1, Mmp8, Mnda, Mnda1, Ms4a4c, Ms4a6d, Mx1, Naa20, Nceh1, Ncoa7, Ngp, Nlrc5, Nmral1, Nqo1, Nt5c3, Oas1a, Oas2, Oas3, Oas11, Oas12, Ogfr, Papd7, Parp10, Parp11, Parp12, Parp14, Phf11d, Pik3ap1, Pla2g7, Plec, Pnpt1, Ppm1k, Pydc4, Pyhin1, Ramp3, Rnf213, Rnf8, Rsad2, Rtp4, Samd91, Scin, Sdc3, Setdb2, Sgcb, Shisa5, Slco3a1, Slfn1, Slfn3, Slfn4, Slfn5, Slfn8, Slfn9, St3ga16, Tcstv3, Tdrd7, Tiparp, Tmem140, Tmeml84b, Tnfsf10, Torlaip2, Tor3a, Trafd1, Trim25, Trim30a, Trim30d, Trim34a, Trim34b, Tspo, Uba7, Ubr4, Usp18, Wnt10a, Xaf1, Xaf1, Zc3hav1, Zcchc2, Zfyve26, Znfx1, and Zufsp; xvi) determining the level of expression of at least one gene selected from the group consisting of Ccdc711, D13ERTD608E, Fads2, Gm2a, Ifi2711, Ighm, Klk1, Scd2, Siglech, and Tspan2; xvii) determining the level of expression of at least one gene selected from the group consisting of CC12, CYBASC3, CYP1B1, FCAR, HBEGF, ID1, IL1B, IL4I1, MSC, NQO1, PPP1R15A, PRDM1, SLC7A11, SRXN1, TIPARP, TMEM138, TXNRD1, and VEGF; xviii) determining the level of expression of at least one gene selected from the group consisting of BCL2, CACNA2D3, C13ORF18, C20ORF103, C5ORF13, CDCA7, DEPDC6, GATM, HAL, HSPA1A, HSPC049, LOC645919, LRMP, OAF, POU4F2, RASGRP2, RET, SERPINB2, SERPINB8, SPFH1, and TDRD7; xix) determining the level of expression of at least one gene selected from the group consisting of ABCC1, ABHD12, ABHD5, ACPP, ACSL1, ADFP, ADORA2B, ADORA3, AHRR, AKNA, AKR1C1, AKR1C2, AKR1C3, ALAS1, ALOX5AP, ANKRD57, ANXA2, APBB1IP, APRIN, ARHGAP20, ARHGEF3, ARRB2, ARRDC4, ASB2, ATF5, ATG7, ATP6V0B, ATP6V0C, ATP9A, ATP9B, AXL, AYTL1, BCL2A1, BCL3, BCL6, BHLHB2, BTG1, BTG2, BTG3, C10ORF22, C10ORF54, C10ORF56, C12ORF35, C13ORF31, C14ORF43, C15ORF39, C17ORF32, C19ORF58, C1ORF122, C1ORF144, C1ORF162, C1ORF21, C1ORF38, C3AR1, C5ORF20, C6ORF166, C9ORF16, C9ORF88, CALN1, CARD15, CCL2, CCL5, CCND3, CCNL1, CCR1, CD109, CD244, CD300A, CD40, CD44, CD83, CD9, CDCA4, CDK5RAP2, CDKN1A, CHST11, CIDEC, CKB, CLEC5A, CLEC7A, CMTM3, CPEB2, CPEB4, CSF1R, CSGLCA-T, CSGLCA-T, CSPG2, CSPG2, CTSB, CTSH, CUTL1, CXCL1, CXCL2, CXXC5, CYBASC3, CYBB, CYLD, CYLD, CYP1B1, DDB1, DGAT2, DKFZP68601327, DOC1, DOK2, DUSP6, EBI2, ECGF1, ECOP, EFHD2, EIF1, ELL2, ELOVL1, EMP2, EMR2, EPAS1, EPB41L3, EPB41L3, EXT1, F3, FADS3, FAM100B, FCAMR, FCAR, FGD3, FGD4, FGL2, FLJ20489, FLJ20701, FLJ90013, FLRT2, FPRL1, FTH1, FUCA1, GAS7, GCNT1, GNA15, GPR35, GPR68, GSR, GSR, H2A, HBEGF, HERPUD1, HIPK2, HIST2H2AA, HIVEP1, HMOX1, HNRPLL, HPCAL1, ID1, ID2, IER5, IFI30, IFNGR1, IFNGR2, IGFBP3, MORA, IL1B, IL1R1, IL1RN, IL1RN, IL21R, IL27RA, IL27RA, IL4I1, IL4R, IRF5, ITGB7, JDP2, JUN, JUNB, JUND, KCNN4, KIAA0247, KIAA0999, KIAA1505, KIAA1706, KIAA1913, KITLG, KLF13, KLF4, KLF6, KLHL18, LACTB, LAT, LHX2, LOC113179, LOC338758, LOC440934, L0054103, LOC644242 LOC648998 LOC650429, LOC650446, LOC651816, LOC653524, LOC653361, LOC653840, LOC653361, LOC653506, LOC653610, LOC653840, LOC653626, LPAAT-THETA, LPL, LPXN, LRG1, LRP10, MAFB, MAFF, MALT1, MAML2, MAP1LC3B, MARCKSL1, MBP, MCL1, ME1, METRNL, MGAT4A, MGC13379, MGLL, MMP2, MMP9, MOBKL2A, MSC, MST150, MTF1, MTUS1, MYH10, NAB1, NCF1, NCF2, NCF4, NEU1, NFE2L3, NFKB1, NFKB2, NFKBIA, NFKBIE, NFXL1, NINJ1, NOTCH1, NOTCH2NL, NPTX1, NQO1, NRP1, NRP2, NT5E, NUAK1, P2RY5, P2RY6, PACSIN2, PDCD6, PDK4, PDLIM4, PECAM1, PEX19, PGD, PHLDA1, PHLDA2, PIK3R5, PIR, PITPNA, PKM2, PLAU, PLAUR, PLEKHO1, PNKD, POPDC3, PPIF, PPP1R15A, PRDM1, PRKCA, PSCD4, PSCDBP, PSMD1, PTAFR, PTGS1, PTPN14, PTPRE, PTX3, QPRT, RAB13, RAB27B, RAB38, RAB6IP1, RAI17, RAP2B, RAPGEF1, RCN1, RELB, RGL1, RGS1, RGS2, RIN3, RIT1, RND3, RSNL2, RSPO3, RUNX3, SAMSN1, SAP30, SASH1, SAT1, SDC4, SEMA4C, SERPINE2, SERTAD1, SFRS7, SGK, SH3GL1, SH3TC1, SLAMF8, SLC15A3, SLC16A3, SLC20A1, SLC23A2, SLC25A14, SLC25A19, SLC25A20, SLC2A1, SLC2A6, SLC37A2, SLC39A8, SLC43A2, SLC45A3, SLC4A2, SLC4A5, SLC6A6, SLC7A11, SLC7A11, SLIC1, SMOX, SNAI3, SOD2, SPRY2, SPSB1, SQRDL, SQSTM1, SRXN1, SSH1, ST3GAL5, STAT1, STK40, TFAP2A, TFDP1, TFEB, TGIF, THBD, TIPARP, TMEM138, TMTC1, TNFAIP3, TNFAIP6, TNFAIP8L1, TNFRSF10D, TNFRSF1B, TNFRSF21, TNFSF13B, TNFSF7, TP53BP2, TRAF3, TRAF3IP2, TRIB1, TRIB3, TRIM16, TRIM16L, TRPA1, TRPS1, TRPS1, TSHZ3, TTLL4, TXNRD1, UBE2S, UGCG, ULBP2, UPP1, URP2, VASH1, VEGF, VSNL1, YRDC, ZBTB24, ZCCHC10, ZFAND5, ZFP36L1, ZNF366, ZNF516, and ZNF697; xx) determining the level of expression of at least one gene selected from the group consisting of ABHD14B, ACTN1, ACY1L2, ADA, ADD2, AFF1, AIG1, AK2, AKAP1, ALS2CR13, ANKRD45, ANKRD55, APPL, ARHGEF6, ATG16L2, ATP8B3, ATP8B4, ATPBD1C, B3GNT7, BCL11A, BCL2, BMP8B, BRE, BSPRY, BTBD14A, C13ORF18, C13ORF18, C14ORF106, C15ORF41, C16ORF73, C1ORF121, C1ORF63, C1QBP, C1S, C20ORF103, C20ORF112, C20ORF12, C3ORF14, C5ORF13, C6ORF147, C7ORF24, C9ORF103, CABC1, CACNA2D3, CACYBP, CALCOCO2, CAMSAP1L1, CAMSAP1L1, CAT, CAV1, CDCA7, CERKL, CHST12, CHST5, CITED4, CLINT1, CLSTN2, CLTCL1, CNTN4, COL4A1, COL8A2, CUGBP2, CXORF21, DAB1, DENND4A, DEPDC6, DHRS9, DMRT2, DUT, EIF4A2, ESD, FLJ12078, FLJ20152, FLJ23861, FLJ36166, FOXP1, GATM, GGA2, GOLGA1, GOLGA8C, GOLGA8D, GOLGA8E, GOLGA8F, GOLGA8G, GPD1L, GPR18, HADH, HAL, HDAC9, HGF, HIG2, HISPPD1, HNRPA3, HNRPH3, HOXB3, HSPA1A, HSPA4L, HSPB1, HSPC049, ID2, ID2B, IDH1, IDH1, IHPK2, IRX3, ITGA4, KBTBD11, KCNN2, KIAA0960, KLF10, LARS, LGR4, LIMA1, LIX1L, LOC129285, LOC148203, LOC197322, LOC203274, LOC220594, LOC254559, LOC284702, LOC285084, LOC285758, LOC340061, LOC340061, LOC388189, LOC474170, LOC643458, LOC645919, LOC646456, LOC90835 LONRF1, LRMP, LYST, MACF1, MDH1, METTL7B, METTL8, MICAL1, MLSTD1, MNDA, MRPL24, MS4A3, MS4A4A, MS4A6A, MS4A7, MSRB3, MT1E, MT1H, MT1M, MTBP, MTHFD1, MTL5, MTR, MUC19, MUM1, MYADM, NAPSB, NAPSB, NAT11, NOC2L, NPAL3, OAF, OCRL, OMA1, OSBPL1A, OXCT2, PDCD4, PHACTR3, PHYH, PIGM, PIWIL4, PNMA6A, POU4F2, PRKAB2, PRLR, PSAT1, PSAT1, PTGER3, PTPLAD2, RABGAP1L, RAD17, RASGRP2, RBKS, RET, RNASEH2B, RNASET2, SELPLG, SERPINB10, SERPINB2, SERPINB8, SERPINI2, SKAP2, SLAIN1, SLC16A4, SLC22A15, SLC22A16, SLC40A1, SMARCA2, SNAPC3, SNX10, SPFH1, SPTBN1, ST3GAL3, STAR, STRBP, SYNPO2, TADA1L, TCFL5, TDRD7, THTPA, TIFA, TLE1, TMEM14A TOP2B, TPD52, TPM1, TRAF3IP3, TSPAN2, TTC9C, UBE2B, UBP1, UHRF2, VLDLR, VPS35, WASF1, WDFY1, WDR49, WDR68, WHDC1L1, WHDC1L2, ZBTB33, ZBTB44, ZF, ZNF207, ZNF519, ZNF658, and ZNF92; xxi) determining the level of expression of at least one gene selected from the group consisting of CCL2, CCL5, CXCL10, IL1RN, and MMP9; xxii) determining the level of expression of at least one gene selected from the group consisting of CCL5, CXCL10, and MMP9; xxiii) determining the level of expression of at least one gene selected from the group consisting of IL10 and CCL2; xxiv) determining the level of expression of at least one gene selected from the group consisting of IFNg, TNF, CCL3, CXCL8, and IL-10; xxv) determining the level of expression of at least one gene selected from the group consisting of MMP9, CCL2, CCL5, CXCL1, and IL1B; xxvi) determining the level of expression of at least one gene selected from the group consisting of MMP9, CXCL10, CCL2, and CCL5; xxix) determining the level of expression of at least one gene selected from the group consisting of CCL3, MMP9, CCL22, CCL24, CX3CL1, CCL20, CCL2, TNF, IL8, CCL13, CCL5, IL1B, CCL8, IL10, CXCL11, CXCL13, CXCL10, CCL7, CCL1, CXCL1, IFNg, CCL26, and MIF; or xxx) determining the level of expression of at least one gene selected from the group consisting of CCL3, MMP9, CCL22, CCL24, CX3CL1, CCL20, CCL2, TNF, IL8, CCL13, CCL5, IL1B, CCL8, IL10, CXCL11, CXCL13, CXCL10, CCL7, CCL1, CXCL1, IFNg, CCL26, MIF, IL16, IL6, CCL25, IL2, CCL19, CXCL2, CXCL9, and CXCL5, thereby characterizing the glatiramer acetate related drug substance or drug product of step a).

3. 发明申请

US20160074380A1 Treatment Of Neurodegenerative Diseases With Combination Of Laquinimod And Fingolimod 审中-公开
标题翻译：治疗组合拉喹莫德和芬戈莫德的神经退行性疾病
公开(公告)号：US20160074380A1
公开(公告)日：2016-03-17
申请号：US14854790
申请日：2015-09-15
申请人： Michael Hayden , Liat Hayardeny , David Ladkani
发明人： Michael Hayden , Liat Hayardeny , David Ladkani
IPC分类号： A61K31/4704 , A61K45/06 , A61K31/137
CPC分类号： A61K31/4704 , A61J1/035 , A61K9/0053 , A61K9/14 , A61K9/2866 , A61K31/00 , A61K31/137 , A61K47/02 , A61K47/18 , A61K47/26 , A61P25/00 , A61P25/02 , A61P25/14 , A61P25/16 , A61P25/28 , B65D1/0215 , B65D65/38 , B65D81/266 , A61K2300/00
摘要： This invention provides a method of treating a subject afflicted with a neurodegenerative disease comprising periodic administration of an amount of laquinimod and an amount of fingolimod, wherein the amounts when taken together are effective to treat the subject. Also provided are packages and pharmaceutical compositions comprising laquinimod and fingolimod for treating a subject afflicted with a neurodegenerative disease. Also provided is a pharmaceutical composition comprising laquinimod for use as an add-on therapy or in combination with fingolimod, and a pharmaceutical composition comprising fingolimod for use as an add-on therapy or in combination with laquinimod, for treating said subject.
摘要翻译：本发明提供了治疗患有神经变性疾病的受试者的方法，其包括定期给予一定量的拉喹莫德和一定量的芬戈莫德，其中所述量一起有效治疗受试者。还提供了包含用于治疗患有神经变性疾病的受试者的拉喹莫德和芬戈莫德的包装和药物组合物。还提供了包含用作附加治疗或与芬戈莫德组合的拉喹莫德的药物组合物，以及包含用于附加疗法的芬戈莫德或与拉喹莫德组合用于治疗所述受试者的药物组合物。

4. 发明申请

US20170224674A1 Treatment Of Neurodegenerative Diseases With Combination Of Laquinimod And Fingolimod 审中-公开
公开(公告)号：US20170224674A1
公开(公告)日：2017-08-10
申请号：US15493997
申请日：2017-04-21
申请人： Michael Hayden , Liat Hayardeny , David Ladkani
发明人： Michael Hayden , Liat Hayardeny , David Ladkani
IPC分类号： A61K31/4704 , A61K9/00 , A61K9/28 , A61K47/26 , B65D65/38 , A61K47/02 , A61K9/14 , A61J1/03 , B65D1/02 , B65D81/26 , A61K31/137 , A61K47/18
CPC分类号： A61K31/4704 , A61J1/035 , A61K9/0053 , A61K9/14 , A61K9/2866 , A61K31/00 , A61K31/137 , A61K47/02 , A61K47/18 , A61K47/26 , A61P25/00 , A61P25/02 , A61P25/14 , A61P25/16 , A61P25/28 , B65D1/0215 , B65D65/38 , B65D81/266 , A61K2300/00
摘要： This invention provides a method of treating a subject afflicted with a neurodegenerative disease comprising periodic administration of an amount of laquinimod and an amount of fingolimod, wherein the amounts when taken together are effective to treat the subject. Also provided are packages and pharmaceutical compositions comprising laquinimod and fingolimod for treating a subject afflicted with a neurodegenerative disease. Also provided is a pharmaceutical composition comprising laquinimod for use as an add-on therapy or in combination with fingolimod, and a pharmaceutical composition comprising fingolimod for use as an add-on therapy or in combination with laquinimod, for treating said subject.

5. 发明授权

US09702007B2 Genetic markers predictive of response to glatiramer acetate 有权
公开(公告)号：US09702007B2
公开(公告)日：2017-07-11
申请号：US14520280
申请日：2014-10-21
申请人： Amir Tchelet , Michael Hayden , Liat Hayardeny , Colin James Douglas Ross , Iris Grossman , David Ladkani
发明人： Amir Tchelet , Michael Hayden , Liat Hayardeny , Colin James Douglas Ross , Iris Grossman , David Ladkani
IPC分类号： A61K38/16 , C12Q1/68
CPC分类号： C12Q1/6883 , A61K38/02 , A61K38/16 , C12Q2600/106 , C12Q2600/156
摘要： The present invention provides a method for treating a human subject afflicted with multiple sclerosis or a single clinical attack consistent with multiple sclerosis with a pharmaceutical composition comprising glatiramer acetate and a pharmaceutically acceptable carrier, comprising the steps of: (i) determining a genotype of the subject at a location corresponding to the location of one or more single nucleotide polymorphisms (SNPs) selected from the group consisting of: Group 1, (ii) identifying the subject as a predicted responder to glatiramer acetate if the genotype of the subject contains one or more A alleles at the location of Group 2, one or more C alleles at the location of Group 3, one or more G alleles at the location of Group 4, or one or more T alleles at the location of kgp18432055, kgp279772, kgp3991733 or kgp7242489; and (iii) administering the pharmaceutical composition comprising glatiramer acetate and a pharmaceutically acceptable carrier to the subject only if the subject is identified as a predicted responder to glatiramer acetate.

6. 发明授权

US4595695A 1'-ethoxycarbonyloxyethyl ester of valproic acid, its preparation and pharmaceutical compositions containing it 失效
标题翻译：丙戊酸的1'-乙氧基羰基氧基乙酯，其制备方法和含有它的药物组合物
公开(公告)号：US4595695A
公开(公告)日：1986-06-17
申请号：US552336
申请日：1983-11-16
申请人： David Ladkani , Haim Yellin , Ben Z. Weiner
发明人： David Ladkani , Haim Yellin , Ben Z. Weiner
IPC分类号： A61K31/265 , A61K31/22 , A61P25/08 , C07C68/06 , C07C69/96 , C07C69/00
CPC分类号： C07C68/06 , A61K31/22 , C07C69/96
摘要： 1'-Ethoxycarbonyloxyethyl ester of di-n-propylacetic acid, also known as valproic acid. The novel compound is prepared by reacting valproic acid with 1-haloethyl ethyl carbonate. There are also provided pharmaceutical compositions for oral administration containing the said ester.
摘要翻译：二正丙基乙酸的1'-乙氧羰基氧基乙酯，也称为丙戊酸。该新化合物是通过使丙戊酸与碳酸1-卤代乙基酯反应来制备的。还提供含有所述酯的用于口服给药的药物组合物。

7. 发明授权

US4889929A Preparation of 1'-ethoxycarbonyl-oxyethyl esters of penicillins 失效
标题翻译：青霉素1'-乙氧羰基 - 氧乙酯的制备
公开(公告)号：US4889929A
公开(公告)日：1989-12-26
申请号：US30280
申请日：1987-03-26
申请人： Jacob Vaya , David Ladkani , Clara Schoenberger , Joseph Kaspi , Gad Salemnick , Haim Yellin , Stephan Cherkez
发明人： Jacob Vaya , David Ladkani , Clara Schoenberger , Joseph Kaspi , Gad Salemnick , Haim Yellin , Stephan Cherkez
IPC分类号： C07D499/08 , C07D499/00 , C07D499/04 , C07D499/46 , C07D499/60 , C07D499/64 , C07D499/68
CPC分类号： C07D499/00 , Y02P20/55
摘要： Process for the preparation of 1'-ethoxy carbonyloxy ethyl esters of penicillins, wherein a compound of the formula ##STR1## in which A is phenyl, phenoxy or 4-hydroxyphenyl, B is hydrogen, an amino group or a protected amino group and Z is hydrogen or a cation selected from the group of alkali metal, tri (lower alkyl ) ammonium and tetra (lower alkyl) ammonium, is reacted with 1-bromoethyl ethyl carbonate in an organic solvent and when B is a protected amino group the protecting group is split off to yield a primary amino group.There are also provided novel compounds of the formula ##STR2## in which Ph is phenyl and R is CH.sub.3 -- or C.sub.2 H.sub.5 --.
摘要翻译：制备青霉素1'-乙氧基羰基氧基乙酯的方法，其中A为苯基，苯氧基或4-羟基苯基，B为氢，氨基或被保护的氨基的式“IMAGE”的化合物和Z 是氢或选自碱金属，三（低级烷基）铵和四（低级烷基）铵的阳离子在有机溶剂中与1-溴乙基碳酸乙酯反应，当B是被保护的氨基时，保护基被分离以产生伯氨基。还提供了新颖的式（IMAGE）化合物，其中Ph是苯基，R是CH 3 - 或C 2 H 5 - 。

8. 发明授权

US4851426A Ethoxycarbonyloxy ethyl esters of non-steroidal anti-inflammatory carboxylic acids and pharmaceutical compositions thereof 失效
标题翻译：非甾族抗炎羧酸的乙氧基羰氧基乙酯及其药物组合物
公开(公告)号：US4851426A
公开(公告)日：1989-07-25
申请号：US810393
申请日：1986-02-12
申请人： David Ladkani , Haim Yellin , Ben Z. Weiner , David Avnir
发明人： David Ladkani , Haim Yellin , Ben Z. Weiner , David Avnir
IPC分类号： A61K31/22 , A61K31/40 , A61K31/403 , A61K31/404 , A61K31/405 , A61P25/04 , A61P29/00 , C07C67/00 , C07C68/06 , C07C69/96 , C07C209/74 , C07C211/56 , C07C229/38 , C07C229/58 , C07C313/00 , C07C317/44 , C07D207/32 , C07D207/337 , C07D209/26 , C07D209/28
CPC分类号： C07C68/06 , A61K31/22 , C07C229/38 , C07C229/58 , C07C69/96 , C07D207/337 , C07D209/26 , C07D209/28
摘要： Novel esters of the general formula ##STR1## in which ##STR2## is the acyl residue of a non-steroidal anti-inflammatory compound containing a carboxylic acid function. The novel esters are prepared by reacting an acide R--COOH when R is as above, with 1-haloethyl ethyl carbonate. There are also provided pharmaceutical compositions containing any of the said novel esters.
摘要翻译：新颖的通式（I）的酯，其中是含有羧酸官能团的非甾族抗炎化合物的酰基残基。当R如上所述时，通过使酰基R-COOH与1-卤代乙基碳酸乙酯反应来制备新的酯。还提供含有任何所述新型酯的药物组合物。

9. 发明授权

US4997824A Combination of cholecalciferol derivatives for the treatment of renal bone disease 失效
标题翻译：胆钙化甾醇衍生物联合用于治疗肾脏骨病
公开(公告)号：US4997824A
公开(公告)日：1991-03-05
申请号：US76459
申请日：1987-07-22
申请人： Mordecai Popovtzer , Ben Z. Weiner , Shmuel Edelstein , Zeev Mazor , David Ladkani , Benjamin Shalita , John A. Kanis
发明人： Mordecai Popovtzer , Ben Z. Weiner , Shmuel Edelstein , Zeev Mazor , David Ladkani , Benjamin Shalita , John A. Kanis
IPC分类号： A61K31/59 , A61P3/00 , A61P13/02 , A61P15/00 , A61P43/00
CPC分类号： A61K31/59
摘要： A method and composition for an improved treatment of human renal osteodystrophy, comprising the administration of 6-40 mcg/d (micrograms per day) of 24,25(OH).sub.2 D.sub.3 in combination with amounts of 1-alpha(OH)D.sub. 3 or 1,25(OH).sub.2 D.sub.3 or DHT.sub.2, which will maintain in the serum of patients the calcium concentration at 10-11 mg/dl (milligrams per deciliter) and the phosphate concentration at 5.5-6.0 mg/dl (milligrams per deciliter) and the numerical multiplication product of calcium x phosphate not more than 60-65.

10. 发明申请

US20160213633A1 METHOD OF INDUCING ANTI-GLATIRAMER ACETATE ANTIBODY RESPONSE 审中-公开
标题翻译：诱导抗乙酰胆碱抗体反应的方法
公开(公告)号：US20160213633A1
公开(公告)日：2016-07-28
申请号：US14800014
申请日：2015-07-15
申请人： David Ladkani , Natalia Ashtamker , Shlomo Bakshi , Bracha Timan
发明人： David Ladkani , Natalia Ashtamker , Shlomo Bakshi , Bracha Timan
IPC分类号： A61K31/198 , G01N33/68 , A61K9/00
CPC分类号： G01N33/6854 , A61K9/0019 , A61K31/785 , A61K39/0008 , A61K47/26 , A61K2039/545 , G01N2800/285 , G01N2800/52
摘要： The present invention provides methods of inducing anti-glatiramer acetate specific antibodies in a human subject afflicted with multiple sclerosis, comprising administration to the human subject of three subcutaneous injections of a 40 mg/ml dose of glatiramer acetate per week for at least 12 months, such that the level of anti-GA specific antibodies in the blood or serum of the human subject i) increases for up to about 6 months after an initial 40 mg/ml dose of glatiramer acetate of the administration is administered to the human subject; ii) increases at a greater rate during the first month after the initial 40 mg/ml dose of glatiramer acetate compared to the rate of increase after the first month to the third month after the initial 40 mg/ml dose of glatiramer acetate; iii) peaks at about 3 or about 6 months or between about 3 and about 6 months after the initial 40 mg/ml dose of glatiramer acetate; and iv) is higher than baseline at least about 12 months after the initial 40 mg/ml dose of glatiramer acetate, wherein the 40 mg/ml dose of glatiramer acetate is in a prefilled syringe containing 1 ml of an aqueous pharmaceutical solution of 40 mg/ml of glatiramer acetate and 40 mg/ml mannitol, and wherein the aqueous pharmaceutical solution has a pH in the range of 5.5 to 7.0.
摘要翻译：本发明提供了在患有多发性硬化症的人类受试者中诱导抗格拉特姆醋酸酯特异性抗体的方法，包括每周给予人受试者三次皮下注射40mg / ml剂量的醋酸格拉司他至少12个月，使得在对受试者施用给药的初始40mg / ml剂量的醋酸格拉司他后，人类受试者的血液或血清中抗GA特异性抗体的水平i）增加高达约6个月; ii）在最初40mg / ml剂量的醋酸格拉司他与在最初40mg / ml剂量的醋酸格拉默之后的第一个月至第三个月之间的增加速率之后的第一个月中以较高的速率增加; iii）在最初的40mg / ml剂量的醋酸格拉默之后约3或约6个月或大约3至6个月之间的峰值; 和iv）在初始40mg / ml剂量的醋酸格拉默后至少约12个月时高于基线，其中40mg / ml剂量的醋酸格拉默是在预充式注射器中，其含有1ml 40mg的药物水溶液 / ml醋酸格拉默和40mg / ml甘露醇，其中药用水溶液的pH在5.5-7.0的范围内。

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