Atelocollagen for protein and gene delivery

Advanced Drug Delivery Reviews

Volumn 55, Issue 12, 2003, Pages 1651-1677

  Sano, Akihiko ^a   Maeda, Miho ^a   Nagahara, Shunji ^a   Ochiya, Takahiro ^b   Honma, Kimi ^c   Itoh, Hiroshi ^c   Miyata, Teruo ^c   Fujioka, Keiji ^a  

^a DAINIPPON SUMITOMO PHARMA CO LTD   (Japan)

^b NATIONAL CANCER CENTER RESEARCH INSTITUTE   (Japan)

^c Koken Bioscience Institute   (Japan)

Author keywords

Adenovirus vector; Antisense DNA; Collagen; DDS; DNA vaccine; Gene therapy; Minipellet; Plasmid DNA; Protein; Sustained release

Indexed keywords

CONTROLLED DRUG DELIVERY; DNA; ENZYME KINETICS; GENE TRANSFER; VACCINES;

GENE DELIVERY; GENE THERAPY;

COLLAGEN;

ADENOVIRUS VECTOR; ATELOCOLLAGEN; COLLAGEN; COMPLEMENTARY DNA; DNA VACCINE; DRUG CARRIER; FIBROBLAST GROWTH FACTOR 4; GOSERELIN; HUMAN GROWTH HORMONE; HUMAN SERUM ALBUMIN; LEUPRON DEPO; OUTER MEMBRANE PROTEIN; PLASMID DNA; PLASMID VECTOR; POLYNUCLEOTIDE; PROTEIN; UNCLASSIFIED DRUG; WATER;

ABSORPTION; ARTICLE; BIOCOMPATIBILITY; CIRCULATION; DECOMPOSITION; DNA DEGRADATION; DRUG DELIVERY SYSTEM; DRUG EFFECT; DRUG EFFICACY; DRUG FORMULATION; DRUG MECHANISM; DRUG POTENCY; ENZYME METABOLISM; FILM; GENE EXPRESSION; GENE EXPRESSION REGULATION; GENE THERAPY; GENE TRANSFER; GENETIC CODE; GENETIC STABILITY; HUMAN; INJECTION; NONHUMAN; PLASMID; PRIORITY JOURNAL; PROTECTION; SOLUBILITY; STRUCTURE ANALYSIS; TECHNOLOGY; VIRAL GENE DELIVERY SYSTEM;

EID: 0242626053     PISSN: 0169409X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.addr.2003.08.005     Document Type: Article

References (90)

1. Rubin A.L., Miyata T., Stenzel K.H. Collagen: medical and surgical applications. J. Macromol. Sci., Chem., A. 3(1):1969;113-118.
2. Doillon C.J., Whyne C.F., Brandwein S., Silver F.H. Collagen-based wound dressings: control of the pore structure and morphology. J. Biomed. Mater. Res. 20:1986;1219-1228.
3. Kojima K., Amano T. Injectable collagen for soft tissue contour defects. J. Transp. Med. 39:1985;6-13.
4. Stenzel K.H., Miyata T., Rubin A.L. Collagen as a biomaterial. Annu. Rev. Biophys. Bioeng. 3:1974;231-253.
5. Sanders L.M. Drug delivery systems and routes of administration of peptide and protein drugs. Eur. J. Drug Metab. Pharmacokinet. 15:1990;95-102.
6. Ranade V.V. Drug delivery systems: 3A. Role of polymers in drug delivery. J. Clin. Pharmacol. 30:1990;10-23.
7. Folkman J., Long D.M. The use of silicone rubber as a carrier for prolonged drug therapy. J. Surg. Res. 4:1964;139-142.
8. Creque H.M., Ranger R., Folkman J. One month of sustained release of insulin from a polymer implant. Diabetes. 29:1980;37-40.
9. Heya T., Okada H., Tanigawara Y., Ogawa Y., Toguchi H. Effects of counteranion of TRH and loading amount on control of TRH release from copoly(dl-lactic/glycolic acid) microspheres prepared by an in-water drying method. Int. J. Pharm. 69:1991;69-75.
10. Furr B.J.A., Hutchinson F.G. A biodegradable delivery system for peptides: preclinical experience with the gonadotrophin-releasing hormone agonist Zoladex® J. Control. Release. 21:1992;117-128.
11. Hongkee S. Stabilization of proteins against methylene chloride/water interface-induced denaturation and aggregation. J. Control. Release. 58:1999;143-151.
12. Hora M.S., Rana R.K., Nunberg J.H., Tice T.R., Gilley R.M., Hudson M.E. Controlled release of interleukin-2 from biodegradable microspheres. Bio/Technology. 8:1990;755-758.
13. Herberger J.D., Wu C., Dong N., Tracy M.A. Characterization of prolease® human growth hormone PLGA microspheres produced using different solvents. Proc. Int. Symp. Control. Release Bioact. Mater. 23:1996;835-836.
14. Rubino O.P., Kowalsky R., Swarbrick J. Albumin microspheres as a drug delivery system: relation among turbidity ratio, degree of cross-linking, and drug release. Pharm. Res. 10:1993;1059-1065.
15. Miyata T. Collagen and fibrin. Ikigaku. 59(3):1989;154-157. (in Japanese).
16. Miller J.M., Zoll D.R., Brown E.O. Clinical observation on use of an extruded collagen suture. Arch. Surg. 88:1964;167-174.
17. Chvapil M., Kronenthal R.L., Winkle W. Jr. Medical and surgical applications of collagen. Int. Rev. Connect. Tissue Res. 6(1):1973;1-61.
18. Hirasawa T., Sano A., Fujioka K., Inoue K., Miyata K., Nakano M., Yamashita K., Hayakawa T. Biodegradability of 'Minipellet' a new drug formulation using atelocollagen as a drug carrier material, in the rhesus monkey. Biomed. Res. 18(2):1997;149-159.
19. Maeda M., Tani S., Sano A., Fujioka K. Microstructure and release characteristics of the minipellet, a collagen-based drug delivery system for controlled release of protein drugs. J. Control. Release. 62:1999;313-324.
20. Maeda M., Kadota K., Kajihara M., Sano A., Fujioka K. Sustained release of hGH from collagen film and evaluation of the effect on wound healing in db/ db mice. J. Control. Release. 77:2001;261-272.
21. Nakano M., Misaki Y., Hukuoka T., Nakayama Y., Miyata K., Inoue K., Kato Y., Yoshitake A. Toxicity of SM-10500 in rats and rhesus monkeys. Kiso to Rinsho (in Japanese). 29:1995;1665-1673.
22. Fujioka K., Maeda M., Hojo T., Sano A. Protein release from collagen matrices. Adv. Drug Deliv. Rev. 31:1998;247-266.
23. Saigusa T., Arita J., Iriki M., Aisaka A., Takada Y., Fujioka K. Attenuation of interferon-a-induced fever by a low dose interferon-a pretreatment: a possible mechanism underlying the decreased pyrogenic action of an interferon-a long-acting formulation. J. Auton. Nerv. Syst. 33:1996;46-53.
24. Yamaoka T., Ishii T., Takada Y., Fujioka K., Yanagi Y., Kataoka T. Proceedings of the Japanese Cancer Association 48th Annual Meeting. 1989;368.
25. Nakajima S., Kuroki T., Nishiguchi S., Ikeoka N., Takeda T., Shiomi S., Kobayashi K., Ichida F. Phase I trial of long-acting preparation (SM-10500) of natural interferon-(HLBI). Kiso to Rinsho (Clinical Report). 28(13):1994;4219-4232.
26. Matsuoka I., Sakagami K., Shiozaki S., Uchida S., Fujiwara T., Gohchi A., Orita K. Development of an interleukin-2 slow delivery system. Trans.-Am. Soc. Artif. Intern. Organs. 34:1988;729-731.
27. Shiozaki S., Sakagami K., Matsuoka J., Uchida S., Miyazaki M., Orita K. Sustained-release formulation of interleukin-2 (IL-2)-preliminary study of IL-2 mini-pellet. Drug Deliv. Syst. 2:1987;101-106.
28. Fujiwara T., Sakagami K., Orita K. Antitumor effects of a new interleukin-2 slow delivery system on methylcholanthrene-induced fibrosarcoma in mice. J. Cancer Res. Clin. Oncol. 116:1990;141-148.
29. Fujiwara T., Sakagami K., Matsuoka J., Shiozaki S., Uchida S., Fujioka K., Takada Y., Onoda T., Orita K. Application of an interleukin 2 slow delivery system to the immunotherapy of established murine colon26 adenocarcinoma liver metastases. Cancer Res. 50:1990;7003-7007.
30. Inui K., Maeda M., Sano A., Fujioka K., Yutani Y., Sakawa A., Yamamoto Y., Kato Y., Koike T. Local application of basic fibroblast growth factor minipellet induces the healing of segmental bony defects in rabbits. Calcif. Tissue Int. 63:1998;490-495.
31. Hosokawa R., Kikuzaki K., Kimoto T., Matsura T., Chiba D., Wadamoto M., Sato Y., Maeda M., Sano A., Akagawa Y. Controlled local application of basic fibroblast growth factor (FGF-2) accelerates the healing of GBR: an experimental study in beagle dogs. J. Clin. Oral. Implants Res. 11:2000;345-353.
32. Yamamoto S., Yoshimine T., Fujita T., Kuroda R., Irie T., Fujioka K., Hayakawa T. Protective effect of NGF atelocollagen mini-pellet on the hippocampal delayed neuronal death in gerbils. Neurosci. Lett. 141:1992;161-165.
33. Koseki N., Takamoto O., Sasaki Y., Maeda H., Sano A., Fujioka K., Sato A., Miyata T., Muhammad A.K.M.G., Yoshimine T., Hayakawa T. A new application of peptide drug delivery system to the brain. Proc. Int. Symp. Control. Release Bioact. Mater. 23:1996;605-606.
34. Tatum E.L. Molecular biology, nucleic acids, and the future of medicine. Perspect. Biol. Med. 10:1966;19-32.
35. Davis B.D. Prospects for genetic Invention in Man. Science. q170:1970;1279-1283.
36. Smithies O., Gregg R.G., Boggs S.S., Koralewski M.A., Kucherlapati R.S. Insertion of DNA sequences into the human chromosomal beta-globin locus by homologous recombination. Nature. 317:1985;230-234.
37. Cole-Strauss A., Yoon K., Xiang Y., Byrbe B.C., Rice M.C., Gryn J., Hollman W.K., Kmiec E.B. Correction of the mutation responsible for sickle cell anemia by an RNA-DNA oligonucleotide. Science. 273:1996;1386-1389.
38. Yoon K., Cole-Strauss A., Kmiec E.B. Targeted gene correction of episomal DNA in mammalian cells mediated by a chimeric RNA-DNA oligonucleotide. Proc. Natl. Acad. Sci. U. S. A. 93:1996;2071-2076.
39. Goldfard M.P., Weinberg R.A. Generation of novel, biologically active Harvey sarcoma viruses via apparent illegitimate recombination. J. Virol. 38:1981;136-150.
40. Chatis P.A., Holland C.A., Hartley J.W., Rowe W.P., Hopkins N. Role for the 3′ end of the genome in determining disease specificity of Friend and Moloney murine leukemia viruses. Proc. Natl. Acad. Sci. U. S. A. 80:1983;4408-4411.
41. Mann R., Mulligan R.C., Baltimore D. Construction of a retrovirus packaging mutant and its use to produce helper free defective retrovirus. Cell. 33:1983;153-159.
42. Statford-Perricudet L.D., Levrero M., Chasse J.-F., Perricaudet M., Briand P. Evaluation of the transfer and expression in mice of an enzyme-encoding gene using a human adenovirus vector. Hum. Gene Ther. 1:1990;241-256.
43. Rosenfeld M.A., Yoshimura K., Trapnell B., Yoneyama K., Rosenthal E., Dalemans W., Fukayama M., Bargon J., Stier L., Statford-Perricudet L.D., Perricaudet M., Guggino W., Pavirani A., Lecocq J.-P., Crystal R.G. In vivo transfer of the human cystic fibrosis transmembrane conductance regulator gene to the airway epithelium. Cell. 68:1992;143-155.
44. Hanenberg H., Xiao X.L., Dilloo D., Hashino K., Kato I., Williams D.A. Colocalization of retrovirus and target cells on specific fibronectin fragments increases genetic transduction of mammalian cells. Nat. Med. 2:1996;876-882.
45. Cornetta K., Morgan R.A., Anderson W.F. Safety issue related to retroviral mediated gene transfer in human. Hum. Gene Ther. 2:1991;5-14.
46. Crystal R.G., McElvaney N.G., Rosenfeld M.A., Chu C.S., Mastrangeli A., Hay J.G., Brody S.L., Jaffe H.A., Eissa N.T., Danel C. Administration of an adenovirus containing the human CFTR cDNA to the respiratory tract of individuals with cystic fibrosis. Nat. Genet. 8:1994;42-51.
47. Felgner P.L., Gadek Y.R., Holm M., Roman R., Chan H.W., Wenz M., Northop J.P., Ringold G.M., Danielson M. Lipofection: a highly efficient, lipid-mediated DNA-transfection procedure. Proc. Natl. Acad. Sci. U. S. A. 84:1987;7413-7417.
48. Gao X., Huang L. A novel cationic liposome reagent for efficient transfection of mammalian cells. Biochem. Biophys. Res. Commun. 179:1991;280-285.
49. Hofland H.E., Nagy D., Liu J.J., Spratt K., Lee Y.L., Danos O., Sullivan S.M. In vivo gene transfer by intravenous administration of stable cationic lipid/DNA complex. Pharm. Res. 14:1997;742-749.
50. Turunen M.P., Hiltunen M.O., Ruponen M., Virkamaki L., Szoka F.C. Jr., Urtti A., Yla-Herttuala S. Efficient adventitial gene delivery to rabbit carotid artery with cationic polymer-plasmid complexes. Gene Ther. 6:1999;6-11.
51. Behr J.P., Demeneix B., Loeffler J.-P., Perez-Mutul J. Efficient gene transfer into mammalian primary endocrine cells with lipopolyamine-coated DNA. Proc. Natl. Acad. Sci. U. S. A. 86:1989;6982-6986.
52. Boussif O., Lezoualc'h F., Zanta M.A., Merbny M.D., Scherman D., Demenix B., Behr J.P. A versatile vector for gene and oligonucleotide transfer into cells in culture and in vivo: polyethylenimine. Proc. Natl. Acad. Sci. U. S. A. 92:1995;7297-7301.
53. Kaneda Y., Iwai K., Uchida T. Increased expression of DNA cointroduced with nuclear protein in adult rat liver. Science. 243:1989;375-379.
54. Jeffrey B.U., Jerald C.S., Margaret A.L. DNA vaccines. Curr. Opin. Immunol. 8:1996;531-536.
55. Herbert A.S., Dennis M.K. The regulation of DNA vaccines. Curr. Opin. Biotechnol. 12:2001;299-303.
56. Shea L.D., Smiley E., Bonadio J., Mooney D.J. DNA delivery from polymer matrices for tissue engineering. Nat. Biotechnol. 17:1999;551-554.
57. Murphy W.L., Mooney D.J. Controlled delivery of inductive proteins, plasmid DNA and cells from tissue engineering matrices. J. Periodontal Res. 34:1999;413-419.
58. Alexakis T., Boadi D.K., Quong D., Groboillot A., O'Neill I., Poncelet D., Neufeld R.J. Microencapsulation of DNA within alginate microspheres and crosslinked chitosan membranes for in vivo application. Appl. Biochem. Biotechnol. 50:1995;93-106.
59. Aggarwal N., HogenEsch H., Guo P., North A., Suckow M., Mittal S.K. Biodegradable alginate microspheres as a delivery system for naked DNA. Can. J. Vet. Res. 63:1999;148-152.
60. Lee K.Y., Known I.C., Kim Y.-H., Jo W.H., Jeong S.Y. Preparation of chitosan self-aggregates as a gene delivery system. J. Control. Release. 51:1998;213-220.
61. Roy K., Nao H.Q., Huang S.K., Leong K.W. Oral gene delivery with chitosan-DNA nanoparticles generates immunologic protection in a murine model of peanut allergy. Nat. Med. 5:1999;387-391.
62. Truong-Le V.L., August J.T., Leong K.W. Controlled gene delivery by DNA-gelatin nanospheres. Hum. Gene Ther. 9:1998;1709-1717.
63. Leong K.W., Mao H.Q., Truong-Le V.L., Roy K., Walsh S.M., August J.T. DNA-polycation nanospheres as non-viral gene delivery vehicles. J. Control. Release. 53:1998;183-193.
64. Ochiya T., Nagahara S., Sano A., Itoh H., Terada M. Biomaterial for Gene Delivery: atelocollagen-mediated controlled release of molecular medicine. Curr. Gene Ther. 1:2001;31-52.
65. Weintraub H., Cheng P.F., Conrag K. Expression of transfected DNA depends on DNA topology. Cell. 46:1986;115-122.
66. Pina B., Hache R.G., Arnemann J., Chalepakis G., Slater E.P. Hormonal induction of transfected gene depends on DNA topology. Mol. Cell. Biol. 10:1990;625-633.
67. Durland R.H., Eastman E.M. Manufacturing and quality control of plasmid-based gene expression system. Adv. Drug Deliv. Rev. 30:1998;33-48.
68. Guidance for industry: Guidance for human somatic cell therapy and gene therapy; March 1998; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research.
69. Sano A., Ochiya T., Nagahara S., Hisada H., Takahama Y., Itoh H., Nagai Y., Terada M. Novel plasmid DNA controlled release formulation. Minipellet, 27th International Symposium on Controlled Release of Bioactive Materials. 2000;7307.
70. Ochiya T., Takahama Y., Nagahara S., Sumita Y., Hisada A., Itoh H., Nagai Y., Terada M. New delivery system for plasmid DNA in vivo using atelocollagen as a carrier material: the Minipellet. Nat. Med. 5:1999;707-710.
71. Sakamoto H., Mori M., Taira M., Yoshida T., Matsukawa S., Shimizu K., Sekiguchi M., Terada M., Sugimura T. Transforming gene from human stomach cancers and a noncancerous portion of stomach mucosa. Proc. Natl. Acad. Sci. U. S. A. 83:1986;3997-4001.
72. Konishi H., Ochiya T., Sakamoto H., Tsukamoto M., Saito I., Muto T., Sugimura T., Terada M. Effective prevention of thrombocytopenia in mice using adenovirus-mediated transfer of HST-1 (FGF-4) gene. J. Clin. Invest. 96:1995;1125-1130.
73. Konishi H., Ochiya T., Sakamoto H., Tsukamoto M., Saito I., Muto T., Sugimura T., Terada M. HST-1 oncogene product (FGF-4) stimulates proliferation of megakaryocyte progenitors and promotes the maturation. Oncogene. 13:1996;9-19.
74. Takahama Y., Ochiya T., Tanooka H., Yamamoto H., Sakamoto H., Nakano H., Terada M. Adenovirus-mediated transfer of HST-1/FGF-4 gene protects mice from lethal irradiation. Oncogene. 18:1999;5943-5947.
75. Ochiya T., Naghara S., Sano A., Itoh H., Terada M. A method to augment gene delivery for DNA vaccination in skin through atelocollagen implant. The 6th Annual Meeting 2000. 2000;135 The Japan Society of Gene Therapy, Tokyo, Japan.
76. Nagahara S., Ochiya T., Sano A., Ito H., Miyata T., Terada M. A potentiating administration method of plasmid DNA for DNA vaccination using atelocollagen as a carrier material. 28th International Symposium on Controlled Release of Bioactive Materials. 2001;7040.
77. Stein C.A., Cheng Y.-C. Antisense oligonucleotides as therapeutic agents - is the bullet really magical? Science. 261:1993;1004-1012.
78. Akhtar S., Hughes M.D., Khan A., Bibby M., Hussain M., Nawaz Q., Double J., Sayyed P. The delivery of antisense therapeutics. Adv. Drug Deliv. Rev. 44:2000;3-21.
79. Ma D.D., Rede T., Naqvi N.A., Cook P.D. Synthetic oligonucleotides as therapeutics: the coming of age. Biotechnol. Annu. Rev. 5:2000;155-196.
80. Dropulic B., Jeang K.T. Gene therapy for human immunodeficiency virus infection: genetic antiviral strategies and targets for intervention. Hum. Gene Ther. 5:1994;927-939.
81. Agrawal S., Temsamani J., Galbraith W., Tang J. Pharmacokinetics of antisense oligonucleotides. Clin. Pharmacokinet. 28:1995;7-16.
82. Yu R.Z., Schoenfeld S.L., Geary R.S., Watanabe T.A., Levin A.A. Pharmacokinetic properties in humans. Crooke S.T. Antisense Drug Technology, Principles, Strategies, and Applications. 2001;183-200.
83. Ochiya T., Terada M. Antisense approaches to in vitro organ culture. Methods Enzymol. 314:2000;401-411.
84. K. Hirai, H. Sasaki, H. Sakamoto, K. Asano, Y. Kubota, T. Ochiya, M. Terada, Antisense oligodeoxynucleotide against HST-1/FGF-4 suppresses tumorigenicity of an orthotopic model for human germ cell tumor in Nude Mice, to be submitted.
85. Kadomatsu K., Tomomura M., Muramatu T. cDNA cloning and sequencing of a new gene intensely expressed in early differentiation stages of embryonal carcinoma cells and in mid-gestation period of mouse embryogenesis. Biochem. Biophys. Res. Commun. 151:1988;1312-1318.
86. Tomomura M., Kadomatsu K., Matubara S., Muramatu T. A retinoic acid-responsive gene, MK, found in the teratocarcinoma system. Heterogeneity of the transcript and the nature of the translation product. J. Biol. Chem. 265:1990;10765-10770.
87. Takei Y., Kadomatsu K., Matsui S., Itoh H., Nakazawa K., Kubota S., Muramatsu T. Antisense oligodeoxynucleotide targeted to Midkine, a heparin-binding growth factor, suppresses tumorigenicity of mouse rectal carcinoma cells. Cancer Res. 61:2001;8486-8491.
88. Takei Y., Kadomatsu K., Itoh H., Sato W., Nakazawa K., Kubota S., Muramatsu T. 5′-, 3′-Inverted thymidine-modified antisense oligonucleotide targeting midkine. J. Biol. Chem. 277:2002;23800-23806.
89. Nakazawa K., Nemoto T., Hata T., Seyama Y., Nagahara S., Sano A., Itoh H., Nagai Y., Kubota S. New cancer therapy using ornithine decarboxylase- directed antisense oligonucleotides in the atelocollagen. The 60th Annual Meeting of the Japanese Cancer Association. 2001;734.
90. Honma K., Ochiya T., Nagahara S., Sano A., Yamamoto H., Hirai K., Aso Y., Terada M. Atelocollagen-based gene transfer in cells allows high-throughput screening of gene functions. Biochem. Biophys. Res. Commun. 289:2001;1075-1081.