DOCSLIB.ORG

| Hai Lala at Tatu Wielu Na Mama Hati

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
| Hai Lala at Tatu Wielu Na Mama Hati |HAI LALA AT TATUUS009758577B2 WIELU NA MAMA HATI (12 ) United States Patent ( 10 ) Patent No. : US 9 , 758 ,577 B2 Schurpf et al. (45 ) Date of Patent: * Sep . 12 , 2017 (54 ) COMPOSITIONS AND METHODS FOR (56 ) References Cited GROWTH FACTOR MODULATION U . S . PATENT DOCUMENTS @( 71 ) Applicant: SCHOLAR ROCK , INC ., Cambridge , 5 , 972 ,335 A 10 / 1999 Ferguson et al. MA (US ) 6 , 096 , 506 A 8 / 2000 Lee et al . 6 , 368 , 597 B14 / 2002 Strassmann et al. @( 72 ) Inventors : Thomas Schurpf , Cambridge , MA 6 , 468 , 535 B1 . 10 / 2002 Lee et al. ( US ) ; Nagesh K . Mahanthappa , 6 ,656 ,475 B1 12 / 2003 Lee et al. Cambridge , MA (US ) ; Michelle Marie 7 ,070 , 784 B1 7 / 2006 Halkier et al . 7 , 241 ,444 B2 7 / 2007 Goetsch et al . Straub , Brighton , MA (US ) 7 ,316 , 998 B2 1 /2008 Knopf et al. 7 ,320 ,789 B2 * 1 /2008 Aghajanian et al. C07K 16 / 22 @( 73 ) Assignee : Scholar Rock , Inc. , Cambridge , MA 424 / 130 . 1 (US ) 7 , 371 , 726 B2 5 / 2008 Junker et al. 7 , 432 , 079 B2 10 / 2008 Junker et al. @( * ) Notice : Subject to any disclaimer , the term of this 7 , 632, 499 B2 12 / 2009 Davies et al. patent is extended or adjusted under 35 7 , 635 , 760 B2 12 / 2009 Han et al. 7 , 750 , 128 B2 7 / 2010 Gegg et al . U . S . C . 154 ( b ) by 0 days . 7 , 785 , 587 B28 / 2010 Whittemore et al. 7 ,807 , 159 B2 10 /2010 Chin et al. This patent is subject to a terminal dis 7 , 888, 486 B2 2 / 2011 Walsh et al . claimer . 8 , 063 , 188 B2 11/ 2011 Sayers et al . 8 ,178 , 488 B2 5 /2012 Knopf et al. ( 21 ) Appl. No. : 15 / 187 ,278 8 , 420 , 082 B2 4 /2013 Veldman et al. 8 , 455 , 448 B2 6 / 2013 Jeanplong et al . (22 ) Filed : Jun . 20 , 2016 8 , 710, 016 B2 4 /2014 Seehra et al . 8 , 840, 894 B2 9 / 2014 Stitt et al . (65 ) Prior Publication Data 8 , 871 , 209 B2 10 / 2014 Stitt et al . 8 , 933 ,199 B2 1 /2015 Cload et al. US 2016 /0289318 A1 Oct. 6 , 2016 8 , 992, 913 B2 3 /2015 Mader et al . 8 , 999 ,343 B2 4 /2015 Han et al . 2003 /0129171 AL 7 /2003 Grobet et al . Related U . S . Application Data 2005 /0250936 A1 11/ 2005 Oppermann et al. 2006 / 0034831 A1 2 / 2006 Tobin ( 60 ) Division of application No . 14 /795 , 033 , filed on Jul. 2006 /0263354 A1 * 11/ 2006 Chin CO7K 16 / 22 9 , 2015 , now Pat . No. 9 , 399, 676 , which is a 424 / 133 . 1 continuation of application No . PCT/ US2014 /036933 , filed on May 6 , 2014 . (Continued ) FOREIGN PATENT DOCUMENTS ( 60 ) Provisional application No . 61/ 819 , 840 , filed on May EP 0404097 12 / 1990 6 , 2013 , provisional application No . 61/ 823 , 552 , filed EP 2422811 2 / 2012 on May 15 , 2013 , provisional application No . ( Continued ) 61/ 900 , 438 , filed on Nov . 6 , 2013 . (51 ) Int. Cl. OTHER PUBLICATIONS CO7K 16 / 00 ( 2006 .01 ) Stockis, J . et al. “ Membrane protein GARP is a receptor for latent CO7K 16 / 18 ( 2006 . 01 ) TGF -beta on the surface of activated human Treg. ” Eur J . Immunol. CO7K 16 / 22 ( 2006 .01 ) Dec . 2009; 39 ( 12 ) :3315 - 22 . CO7K 14 /495 ( 2006 . 01 ) (Continued ) COZK 16 / 28 ( 2006 .01 ) C12N 15 / 10 (2006 .01 ) A61K 38 /00 ( 2006 .01 ) Primary Examiner - Elizabeth C Kemmerer (52 ) U . S . CI. CPC . .. .. .. .. .. CO7K 16 / 22 ( 2013 .01 ) ; CO7K 14 /495 ( 74 ) Attorney , Agent, or Firm — McCarter & English , (2013 . 01 ) ; CO7K 16 /005 (2013 .01 ) ; CO7K LLP ; Marcie B . Clarke ; Maria Laccotripe Zacharakis 16 / 2863 ( 2013 . 01 ) ; C12N 15 / 1037 ( 2013 .01 ) ; A61K 38 / 00 ( 2013 .01 ) ; CO7K 2317 / 21 (57 ) ABSTRACT ( 2013 .01 ) ; COZK 2317 / 24 ( 2013 .01 ) ; COOK 2317 / 31 ( 2013 .01 ) ; CO7K 2317 /55 (2013 . 01 ) ; Provided herein are proteins, antibodies, assays and methods CO7K 2317 / 565 ( 2013 . 01 ) ; CO7K 2317 / 76 useful for modulating growth factor levels and /or activities . ( 2013 .01 ) ; CO7K 2317 /92 ( 2013 .01 ) ; CO7K In some embodiments , such growth factors are members of 2317 / 94 ( 2013 .01 ) ; GOIN 2333/ 71 (2013 .01 ) the TGF- B superfamily of proteins . ( 58 ) Field of Classification Search None See application file for complete search history . 16 Claims, 23 Drawing Sheets US 9 , 758 , 577 B2 Page 2 ( 56 ) References Cited European Search Report for EP application No . 13853885. 5 dated May 13 , 2016 . U . S . PATENT DOCUMENTS Japanese Office Action for JP application No . 2015 - 540878 dated Apr . 26 , 2016 . 2007 /0178095 A18 / 2007 Smith et al . 2008 /0206219 AL 8 / 2008 Coussens et al. Notification of Transmittal of the International Search Report and 2008 / 0279834 AL 11/ 2008 Garaczi et al . the Written Opinion of the International Searching Authority , or the 2009 /0136481 AL 5 / 2009 Kambadur et al. Declaration , from International Application No . PCT /US2013 / 2010 /0322925 Al 12 / 2010 Knopf et al . 68613 , dated May 7 , 2014 . 2011/ 0129469 A1 6 / 2011 Koncarevic et al . Battaglia et al. The Tregs ' world according to GARP. Eur J 2011/ 0250198 A 10 / 2011 Wolfman et al. Immunol. Dec . 2009 ; 39 ( 12 ) : 3296 - 300 . 2011/ 0256132 Al 10 / 2011 Ashman et al. Tran DQ . TGF - B : the sword , the wand , and the shield of FOXP3 ( = ) regulatory T cells . J Mol Cell Biol. 2012 (Feb ; 4 ( 1 ) : 29 -37 . FOREIGN PATENT DOCUMENTS Cuende , Julia et al . “ Monoclonal antibodies against GARP / TGF -B1 complexes inhibit the immunosuppresive activity of human regu ?? 2832747 2 / 2015 WO 92 / 00330 AL 1 / 1992 latory T cells in vivo ” , Sci . Transl. Med ., Apr . 22 , 2015 , vol. 7 , Issue WO 94 /09812 A1 5 / 1994 284 , pp . 1 - 12 . WO 00 / 43781 7 / 2000 Cuende, Julia et al . “ Supplemental Materials for Monoclonal anti WO 00 /66620 11 / 2000 bodies against GARP / TGF -B1 complexes inhibit the immunosup WO 01/ 12777 2 / 2001 presive activity of human regulatory T cells in vivo ” , Sci . Transl. WO 02 / 09641 2 / 2002 Med ., Apr. 22 , 2015 , vol . 7 , Issue 284 , pp . 1 - 10 . WO 2005 /010049 2 / 2005 International Preliminary Report on Patentability , International WO 2006 / 106599 Al 10 / 2006 WO 2006 / 116002 11/ 2006 Application No. PCT/ US2014 / 036933 , dated Nov . 19 , 2015 . WO 2007 /050793 A2 3 / 2007 Taylor , R . G . et al ., 1985 . Histopathologic features of phorbol WO 2007 /050793 A2 5 / 2007 myristate acetate - induced lung injury . Lab Invest. 52 ( 1 ) :61 - 70 . WO 2008 /060371 5 / 2008 Studnicka , G . M . et al .( 1994 ) , Human - engineered monoclonal anti WO 2009 / 114702 A2 9 / 2009 bodies retain full specific binding activity by preserving non -CDR WO 2009 / 144457 A2 12 / 2009 complementarity -modulating residues. Protein Eng . Jun . WO 2014 /093531 6 / 2014 1994 ; 7 (6 ): 805 - 14 . WO 2015 /015003 2 / 2015 McFarlane , Craig , et al . Proteolytic processing of myostatin is auto -regulated during myogensis , Developmental Biology , Mar . 23 , OTHER PUBLICATIONS 2005 , pp . 58 -69 , AgResearch , East Street , Hamilton , New Zealand , Department of Biological Sciences , University of Waikato , Hamil Shi, Minlong , et al . “ Latent TGF - B structure and activation ” , ton , New Zealand . Nature , vol. 474 , No . 7351, Jun . 15 , 2011 ( Jun . 15 , 2011 ) , pp . 343 - 349 . * cited by examiner U . S . Patent Sep. 12 , 2017 Sheet 1 of 23 US 9 ,758 ,577 B2 Figure 1 TGFB1 BMP , GDF10 TGFB2 BMPIS / / TGFB3 // myostatin (GOF8 ) wwwwwwwwwwwwwwwwwww BMP8A , 8 bin - 3A BMPO Inhibin -BB inhibin - BC BMPS murosawa Inhibin -BE BMP4 Lefty1 mm 1300 $ Lafty2 Nodalmumamman Anti BMPO (GDF2 ) ories Mullerian BMP10 homone GOFT GOES - UIQIYU- D GOFOGpF OF3 U . S . Patent Sep. 12 , 2017 Sheet 2 of 23 US 9 ,758 ,577 B2 Figure 2 Prodomain Stext ? C }eatae site signalpeptide Growth factor U . S . Patent Sep. 12 , 2017 Sheet 3 of 23 US 9 ,758 ,577 B2 Figure 3 Growth Factor- Prodomain Complex (GPC ) Free latency Associated Peptide (LAP ) Dimer Free Growth Factor Dimer 1 U . S . Patent Sep. 12 , 2017 Sheet 4 of 23 US 9 ,758 ,577 B2 Figure 4 Free latency Associated Peptide (LAP ) Dimer Trigger loop. man Bowtie region Alpha 2 helix mana Arm region Fastener region Latency loop ( also refer?d to as t?? latency lasso ) Amman Alpha 1 helix Residues for extracellular protein asscaths Free Growth Factor Dimer -~ ~ get egin U . S . Patent Sep. 12 , 2017 Sheet 5 of 23 US 9 ,758 ,577 B2 Figure 5 An embodiment of a recombinant GPC 34fde ??d C -terminus maeneo Growth factor domain Proprotein convertase cleavage site Latency - associated peptide (LAP ) Cys residue - HSM SH N - terminus Histidine tags U . S . Patent Sep. 12 , 2017 Sheet 6 of 23 US 9 ,758 ,577 B2 Figure 6 An embodiment of a proprotein convertase cleavage site mutant ( e . g . RXXR - RXG ; D2G ) HSG LSH An embodiment of an N -terminal cysteine mutant ( e . g . C45: Cys4 - Ser ) ????? U . S . Patent Sep. 12 , 2017 Sheet 7 of 23 US 9 ,758 ,577 B2 Figure 7 Embodiments of recombinantproteins Hobok LTBA GARDE prOTGF- B proprotein prOTGF - 6 proprotein proTGF- B proprotein convertase cleavage conv?rtaså c { e \ ????? convertase cleavage site mutant with N site mutant complexed site mutant complexed terminal cysteine with LTBP with GARP mutation H00M TGF- B LAP with N TGF- B LAP complexed terminal cysteine with GARP mutation U . S . Patent Sep. 12 , 2017 Sheet 8 of 23 US 9 ,758 ,577 B2 Figure 8A at Heix GFBIHU some generaltownWWWWWWWWxwwwwwwwwwwwwwwwwww * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * Howto bietetsocialemediergenerelt W * * * * * * * * * ** * * * * * * * * * * * * * * * * * * * * * SUS X00 aime * AGPAAAAAAAAAARROVOCHOSSRBARSVAPOPO CHVCVXRON 46 ous * A8CPAAAAAAAAAAAGVOORRSSRPAPSAPDOPO CHVCVXROX $ point * * * * * * * * * * * * * * * * * * * * * * * * *XXSCOXUY * BXEGLCXICOXRON 2 in * * * * * * * * wwwww * * * * * www ENSBOKBW * XX10NACEYRON
Load more

Recommended publications
  • Regenerative Medicine for the Reconstruction of Hard Tissue Defects in Oral and Maxillofacial Surgery
    http://dx.doi.org/10.5125/jkaoms.2012.38.2.69 EDITORIAL pISSN 2234-7550·eISSN 2234-5930 Regenerative medicine for the reconstruction of hard tissue defects in oral and maxillofacial surgery Young-Kyun Kim, D.D.S., PhD., Editor-in-Chief of JKAOMS Department of Oral and Maxillofacial Surgery, Section of Dentistry, Seoul National University Bundang Hospital, Seongnam, Korea As the most ideal bone graft material to reconstruct hard been published since long ago. tissue with defects, autogenous bone provides excellent bone Since 1965 when Urist3 suggested the concept of osteoin- healing capacity in terms of osteogenesis, osteoinduction, and du ction by bone morphogenic protein (BMP) in cortical osteoconduction. Note, however, that patients and clinicians bone, many researchers have attempted to extract BMP tend to avoid using it due to problems including limited from teeth or osseous tissue for application in clinical amount and donor site complications. As a result, allograft, situations. Note, however, that the extraction of a sufficient xenograft, and alloplastic material (synthetic bones) were amount and application in clinical situations were very developed and applied in clinical surgeries for a long time, difficult4-6. Nonetheless, various BMPs (recombinant human yet they do not have the same bone healing capacity as that BMP, rhBMP) have been recently manufactured by gene of autogenous bone1. recombination based on the cell of mammals or colon In the early stage, hydroxyapatite-type synthetic bone bacillus7-9. was used frequently for ridge augmentation to maintain full Growth factor is very important in bony remodeling and denture and for the reconstruction of tissue with defects healing because it significantly influences the activity of after cyst enucleation.
    [Show full text]
  • Craniomaxillofacial Bone Tissue Engineering – a Translational Approach
    Craniomaxillofacial Bone Tissue Engineering – A Translational Approach by Ahmed Abushahba Clinicum, Faculty of Medicine, University of Helsinki, Finland Doctoral Programme in Oral Sciences (FINDOS) Doctoral School in Health Sciences University of Helsinki ACADEMIC DISSERTATION Doctoral thesis, to be presented, with the permission of the Faculty of Medicine of the University of Helsinki, for public examination in Lecture Hall 2, Biomedicum Helsinki 1, Haartmaninkatu 8, Helsinki, on July 23rd 2021, at 12:00 pm The research was conducted at The Department of Oral and Maxillofacial Diseases Clinicum, Faculty of Medicine University of Helsinki, Finland Doctoral Programme in Oral Sciences (FINDOS), Helsinki SUPERVISORS Professor Riitta Seppänen-Kaijansinkko Department of Oral and Maxillofacial Diseases, University of Helsinki and Helsinki University Hospital Helsinki, Finland Docent Bettina Mannerström Department of Oral and Maxillofacial Diseases, University of Helsinki and Helsinki University Hospital Helsinki, Finland REVIEWERS Professor Sean Peter Edwards Department of Oral and Maxillofacial Surgery, University of Michigan School of Dentistry Michigan, USA Adjunct Professor Niko Moritz Department of Clinical Medicine, Institute of Dentistry, University of Turku Turku, Finland OPPONENT Professor Dr. Dr. Henning Schliephake Department of Oral and Maxillofacial Surgery, the Georg August University of Göttingen Göttingen, Germany The Faculty of Medicine uses the Urkund system (plagiarism recognition) to examine all doctoral dissertations. Dissertationes Scholae Doctoralis Ad Sanitatem Investigandam Universitatis Helsinkiensis, series No. 40/2021 ISBN 978-951-51-7406-2 (paperback) ISBN 978-951-51-7407-9 (PDF) ISSN 2342-3161 (print) ISSN 2342-317X (online) http://ethesis.helsinki.fi Unigrafia Helsinki 2021 In memory of my beloved Father, to Gamal Taha Abushahba, I dedicate this work, ABSTRACT Bone tissue engineering (BTE) has shown a great promise in providing the next generation medical bioimplants for treating bone defects.
    [Show full text]
  • Bone Graft Substitutes for the Promotion of Spinal Arthrodesis
    Neurosurg Focus 10 (4):Article 4, 2001, Click here to return to Table of Contents Bone graft substitutes for the promotion of spinal arthrodesis GREGORY A. HELM, M.D., PH.D., HAYAN DAYOUB, M.D., AND JOHN A. JANE, JR., M.D. Departments of Neurosurgery and Biomedical Engineering, University of Virginia, Charlottesville, Virginia In the prototypical method for inducing spinal fusion, autologous bone graft is harvested from the iliac crest or local bone removed during the spinal decompression. Although autologous bone remains the “gold standard” for stimulat- ing bone repair and regeneration, modern molecular biology and bioengineering techniques have produced unique materials that have potent osteogenic activities. Recombinant human osteogenic growth factors, such as bone mor- phogenetic proteins, transforming growth factor–␤, and platelet-derived growth factor are now produced in highly con- centrated and pure forms and have been shown to be extremely potent bone-inducing agents when delivered in vivo in rats, dogs, primates, and humans. The delivery of pluripotent mesenchymal stem cells (MSCs) to regions requiring bone formation is also compelling, and it has been shown to be successful in inducing osteogenesis in numerous pre- clinical studies in rats and dogs. Finally, the identification of biological and nonbiological scaffolding materials is a crucial component of future bone graft substitutes, not only as a delivery vehicle for bone growth factors and MSCs but also as an osteoconductive matrix to stimulate bone deposition directly. In this paper, the currently available bone graft substitutes will be reviewed and the authors will discuss the novel therapeutic approaches that are currently being developed for use in the clinical setting.
    [Show full text]
  • View Printable PDF Document
    Dietary Supplement Use in the Elderly January 14-15, 2003 Overview Natcher Auditorium Natcher Conference Center, Building 45 Bethesda, MD 20892 Dietary supplements, as sold in the United States, encompass a wide range of products, which include vitamins, minerals, amino acids, herbs, botanicals, and other substances. The frequency of use of dietary supplements among the elderly is high compared with the general population. According to results from the Third National Health and Nutrition Examination Survey conducted between 1988 and 1994, 56% of middle age and older adults consumed at least one supplement on a daily basis as compared with 40% in the general population. In 2001, the Nutrition Business Journal estimated the total sales of dietary supplements at $17.8 billion dollars. The amount of scientific evidence supporting the safety and benefits of dietary supplements among the elderly varies according to the nature and form of the supplement. For certain supplements, e.g., vitamins and minerals, recommended levels of use in the elderly have been established by the Institute of Medicine. All supplements are not safe, and the inappropriate use of some supplements can result in adverse health consequences. Inconsistencies arise as a result of a lack of product standards and the level of scientific evidence required to demonstrate safety and benefits of dietary supplements. Concerns exist regarding supplement use in the elderly population. One concern, relates to the use of prescription drugs and their interactions with dietary supplements. Additional concerns are the potential adverse effects due to perisurgical complications, interactions with over-the-counter medications, contamination of preparations, and mislabeling.
    [Show full text]
  • Insulin-Like Growth Factor-Binding Protein-5 Inhibits Growth and Induces Differentiation of Mouse Osteosarcoma Cells
    Biochemical and Biophysical Research Communications 288, 435–442 (2001) doi:10.1006/bbrc.2001.5785, available online at http://www.idealibrary.com on Insulin-like Growth Factor-Binding Protein-5 Inhibits Growth and Induces Differentiation of Mouse Osteosarcoma Cells Marlon R. Schneider,*,1 Rui Zhou,* Andreas Hoeflich,* Ottheinz Krebs,* Jo¨rg Schmidt,† Subburaman Mohan,‡ Eckhard Wolf,* and Harald Lahm* *Institute of Molecular Animal Breeding, Gene Center of the Ludwig-Maximilian University, Munich, Germany; †Department of Comparative Medicine, National Research Center for Environment and Health, Neuherberg, Germany; and ‡Musculoskeletal Disease Center, Jerry L. Pettis Veterans Administration, Loma Linda, California 92357 Received September 11, 2001 The insulin-like growth factors (IGF-I and IGF-II) The precise role of insulin-like growth factor-binding are recognized stimulators of cellular growth and dif- protein-5 (IGFBP-5) in regulating the growth of tumor ferentiation in several tissues (1). These effects are cells, especially of bone-derived malignant cells, is not regulated systemically and locally by a group of six well understood. We have investigated the biological ac- structurally related proteins designated IGF-binding tivity of IGFBP-5 by transfecting OS/50-K8 mouse osteo- proteins (IGFBP-1 to -6) which have affinities for IGFs sarcoma cells with an expression vector containing the comparable to that of the type I IGF receptor. Although osteocalcin promoter and the complete mouse IGFBP-5 structurally related, each IGFBP has an individual cDNA (OC-IGFBP-5). Overexpression of IGFBP-5 mRNA expression pattern and exerts different functions in- and secretion of increased amounts of bioactive protein cluding stimulation or inhibition of IGF-bioactivity as in conditioned media were demonstrated in different well as IGF-independent actions (2, 3).
    [Show full text]
  • Ep 0496813 B1
    Europaisches Patentamt European Patent Office © Publication number: 0 496 81 3 B1 Office europeen des brevets © EUROPEAN PATENT SPECIFICATION © Date of publication of patent specification: 14.12.94 © Int. CI.5: A61 K 9/127, C07F 9/1 0, C08G 63/68 © Application number: 90916409.7 @ Date of filing: 19.10.90 © International application number: PCT/US90/06034 © International publication number: WO 91/05545 (02.05.91 91/10) The file contains technical information submitted after the application was filed and not included in this specification (54) LIPOSOME MICRORESERVOIR COMPOSITION AND METHOD. ® Priority: 20.10.89 US 425224 © Proprietor: LIPOSOME TECHNOLOGY, INC. 1050 Hamilton Court @ Date of publication of application: Menlo Park, CA 94025 (US) 05.08.92 Bulletin 92/32 @ Inventor: MARTIN, Frank, J. © Publication of the grant of the patent: 415 West Portal Avenue 14.12.94 Bulletin 94/50 San Francisco, CA 94127 (US) Inventor: WOODLE, Martin, C. © Designated Contracting States: 445 Oak Grove 3 AT BE CH DE DK FR GB IT LI LU NL SE Menlo Park, CA 94025 (US) Inventor: REDEMANN, Carl References cited: 3144 Ebano Drive EP-A- 0 072 111 EP-A- 0 118 316 Walnut Creek, CA 94598 (US) EP-A- 0 354 855 WO-A-88/04924 Inventor: RADHAKRISHNAN, Ramachandran WO-A-90/04384 GB-A- 2 185 397 4335 Cambria Street Fremont, CA 94538 (US) Patent Abstracts of Japan, vol. 13, no. 592 Inventor: YAU-YOUNG, Annie 00 (C-671)(3940), 26 December 1989, & JP-A- 4162 Crosby Place 1249717 (Fuji Photo Film Co., Ltd.) 5 October Palo Alto, CA 94306 (US) CO 1989 00 CO Oi Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted.
    [Show full text]
  • (12) United States Patent (10) Patent No.: US 8,383,114 B2 Sloey Et Al
    USOO8383114B2 (12) United States Patent (10) Patent No.: US 8,383,114 B2 Sloey et al. (45) Date of Patent: Feb. 26, 2013 (54) PHARMACEUTICAL FORMULATIONS 6,919,426 B2 7/2005 Boone et al. 7,030,226 B2 4/2006 Sun et al. (75) Inventors: Christopher J. Sloey, Newbury Park, 7,084.2457,037.498 B2 8/20065, 2006 CohenHolmes et et al. al. CA (US); Camille Vergara, Calabasas, 7,153,507 B2 12/2006 van de Winkel et al. CA (US); Jason Ko. Thousand Oaks, CA 7,217,689 B1 5/2007 Elliott et al. (US); Tiansheng Li, Newbury Park, CA 7,220,410 B2 5/2007 Kim et al. (US) 2002/0155998 A1 10/2002 Young et al. 2002/01992 13 A1 12/2002 Tomizuka et al. 2003/0023586 A1 1/2003 Knorr (73) Assignee: Amgen Inc., Thousand Oaks, CA (US) 2003, OO31667 A1 2/2003 Deo et al. - 2003, OO77753 A1 4, 2003 Tischer (*) Notice: Subject to any disclaimer, the term of this 2003/0082749 A1 5/2003 Sun et al. patent is extended or adjusted under 35 2003/01 18592 A1 6/2003 Ledbetter et al. U.S.C. 154(b) by 0 days. 2003/0.133939 A1 7/2003 Ledbetter et al. 2003. O138421 A1 7/2003 van de Winkel et al. 2003.0143202 A1 7/2003 Binley et al. (21) Appl. No.: 12/680,128 2003/0194404 A1 10, 2003 Greenfeder et al. 2003. O19515.6 A1 10, 2003 Minet al. (22) PCT Filed: Sep. 29, 2008 2003/0215444 A1 11/2003 Elliott 2003,0229023 A1 12/2003 Oliner et al.
    [Show full text]
  • Comparison of the Anabolic Effects of Reported Osteogenic Compounds on Human Mesenchymal Progenitor-Derived Osteoblasts
    This is a repository copy of Comparison of the anabolic effects of reported osteogenic compounds on human mesenchymal progenitor-derived osteoblasts. White Rose Research Online URL for this paper: http://eprints.whiterose.ac.uk/156356/ Version: Published Version Article: Owen, R., Bahmaee, H., Claeyssens, F. orcid.org/0000-0002-1030-939X et al. (1 more author) (2020) Comparison of the anabolic effects of reported osteogenic compounds on human mesenchymal progenitor-derived osteoblasts. Bioengineering, 7 (1). 12. https://doi.org/10.3390/bioengineering7010012 Reuse This article is distributed under the terms of the Creative Commons Attribution (CC BY) licence. This licence allows you to distribute, remix, tweak, and build upon the work, even commercially, as long as you credit the authors for the original work. More information and the full terms of the licence here: https://creativecommons.org/licenses/ Takedown If you consider content in White Rose Research Online to be in breach of UK law, please notify us by emailing [email protected] including the URL of the record and the reason for the withdrawal request. [email protected] https://eprints.whiterose.ac.uk/ Article Comparison of the Anabolic Effects of Reported Osteogenic Compounds on Human Mesenchymal Progenitor-derived Osteoblasts Robert Owen 1,2,3,*,†, Hossein Bahmaee 1,2,†, Frederik Claeyssens 1,2 and Gwendolen C. Reilly 1 1 Department of Materials Science and Engineering, INSIGNEO Institute for in silico medicine, The Pam Liversidge Building, Sir Frederick Mappin Building, Mappin Street, Sheffield S1 3JD, UK; [email protected] (H.B); [email protected] (F.C.); [email protected] (G.C.R.) 2 Department of Materials Science and Engineering, University of Sheffield, Kroto Research Institute, Sheffield S3 7HQ, UK 3 Regenerative Medicine and Cellular Therapies, School of Pharmacy, University of Nottingham Biodiscovery Institute, University Park, Nottingham NG7 2RD, UK * Correspondence: [email protected] † Co-first authors.
    [Show full text]
  • Aastrom Biosciences, Inc
    Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of report (date of earliest event reported): May 17, 2005 Aastrom Biosciences, Inc. (Exact name of registrant as specified in its charter) Michigan 0-22025 94-3096597 (State or other jurisdiction of (Commission File No.) (I.R.S. Employer Identification incorporation) No.) 24 Frank Lloyd Wright Drive P.O. Box 376 Ann Arbor, Michigan 48106 (Address of principal executive offices) Registrant’s telephone number, including area code: (734) 930-5555 Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) TABLE OF CONTENTS Item 8.01 Other Events Item 9.01 Financial Statements and Exhibits SIGNATURES EXHIBIT 99.1 Table of Contents Item 8.01 Other Events. (b) On May 17, 2005, Aastrom Biosciences, Inc. published a report providing the results from its feasibility clinical trial in Barcelona, Spain to evaluate the use of Tissue Repair Cells (TRCs) for the treatment of severe long bone non-union fractures.
    [Show full text]
  • Osteogenic Plasmid Genes
    Proc. Natl. Acad. Sci. USA Vol. 93, pp. 5753-5758, June 1996 Medical Sciences Stimulation of new bone formation by direct transfer of osteogenic plasmid genes (gene transfer/rat osteotomy model/bone formation/repair fibroblast/wound healing) JIANMING FANG*, YAO-YAO ZHU*, ELIZABETH SMILEY*, JEFFREY BONADIO*, JEFFREY P. ROULEAUt, STEVEN A. GOLDSTEINt, LAURIE K. MCCAULEYt, BEVERLY L. DAVIDSON§, AND BLAKE J. ROESSLER§ Departments of *Pathology, tSurgery, and §Internal Medicine, University of Michigan Medical School, Ann Arbor, MI 48109; and tDepartment of Periodontics/Prevention and Geriatrics, School of Dentistry, University of Michigan, Ann Arbor, MI 48109 Communicated by Hector F. DeLuca, University of Wisconsin, Madison, WI, February 2, 1996 (received for review November 22, 1995) ABSTRACT Degradable matrices containing expression and prolonged ambulatory impairment and often must be plasmid DNA [gene-activated matrices (GAMs)] were im- treated by operative procedure. External fixation devices may planted into segmental gaps created in the adult rat femur. stabilize fractures at risk for poor healing, but a lack of viable Implantation of GAMs containing 3-galactosidase or lucif- bone in the defect site can lead to structural instability and, at erase plasmids led to DNA uptake and functional enzyme times, infection and bony erosion. Bone grafts also may be expression by repair cells (granulation tissue) growing into used, but they may become infected or, for certain applica- the gap. Implantation of a GAM containing either a bone tions, may provide insufficient bone that is difficult to contour. morphogenetic protein-4 plasmid or a plasmid coding for a Microsurgical transfer of free bone grafts with attached soft fragment ofparathyroid hormone (amino acids 1-34) resulted tissue and blood vessels can mitigate against infection, but the in a biological response of new bone filling the gap.
    [Show full text]
  • Bioabsorbable Polymer and Bone Growth Factor Composites
    Chondral and Osseous Tissue Engineering 2002 Eds. N. Ashammakhi &M. Kellomäki Bioabsorbable Polymer and Bone Growth Factor Composites Laura-Maria Tielinen Summary B one growth factors are small proteins contained by bone tissue. The most intensively investigated bone growth factors are the bone morphogenetic proteins (BMPs) and the transforming growth factor-s (TGF-s). Their local application induces bone formation in experimental fractures and bone defects. Possible clinical applications for bone growth factors include impaired bone healing, inadequate bone stock, and incomplete incorporation of prosthetic implants into bone. In therapeutic use the bone growth factors need a carrier. The carrier should assure local, sustained release of the growth factors which may otherwise be rapidly absorbed before instituting their effect. Several biodegradable materials have been investigated as carriers for bone growth factors, including organic materials, ceramics, and synthetic polymers such as polylactide and polylactide-polyglycolide co-polymer. Bioabsorbable polymers possess several attractive features as delivery systems. They can be engineered to allow release of accurate dosage of bone growth factors and they also allow combining several growth factors to be delivered concomitantly or at different points of time. They can also be manufactured or sculpted into a variety of forms to fit a given tissue defect or to fix a fracture. Moreover, they are both sterilizable and can be resorbed completely. An increasing number of positive results from experimental studies exist which could indicate a possible future success for growth factors within clinical orthopaedic practice. Recently, the first human studies using recombinant human BMP-2 or BMP-7 (osteogenic protein-1, OP-1) have been published.
    [Show full text]
  • Revista Mediunabfinalokinterior
    Revisión de tema Osteobiología: aspectos novedosos del tejido óseo y la terapéutica con el plasma rico en plaquetas Ananías García Cardona, DDC* Grégory Alfonso García, MD¶§ Ómar Ramón Mejía, MD** Mario Vittorino Mejía, MD* Dianney Clavijo Grimaldi, MD¶ Ciro Alfonso Casadiego Torrado, MD¶☼ Resumen Summary El hueso es un tejido dinámico que provee soporte mecánico, The bone is a dynamic tissue that provides mechanical protección física, es un sitio de almacenamiento para support, physical protection, storage site for minerals, and minerales y capacita la génesis del movimiento. La biología enables genesis movement. The bone biology ósea (osteobiología) es regulada por el balance entre la (osteobiology) is regulated by the balance between formación osteoblástica y la resorción osteclástica. La osteoblastic formation and osteoclastic resorption. The homeostasis del hueso esquelético es influenciada por skeletal bone homeostasis is influenced by components of componentes del órgano medular óseo, el sistema the bone marrow organ, neuroendocrine system and neuroendocrino y el sistema hematoinmune. La propuesta hemato-immune system. The purpose of this review is to de esta revisión es describir la biodinámica del órgano óseo, describe the biodynamic of the bone organ, and actual la terapeútica actual con el plasma rico en plaquetas en terapeutics with platelet-rich plasma in guided bone regeneración ósea guiada, un método coquirúrgico regeneration, a co-surgical method employed to increase empleado para incrementar la cantidad y la calidad del the quantity and quality of the bone. [García A, García GA, hueso. [García A, García GA, Mejía OR, Clavijo D, Mejía OR, Clavijo D, Casadiego CA. Osteobiology: newest Casadiego CA.
    [Show full text]