A new form of Filgrastim with sustained duration in vivo and enhanced ability to mobilize PBPC in both mice and humans

Experimental Hematology - Tập 27 Số 12 - Trang 1724-1734 - 1999
Graham Molineux1, Olaf Kinstler1, Bob Briddell1, Cynthia Hartley1, Patricia McElroy1, Patrick J. Kerzic1, Weston Sutherland1, Greg Stoney1, Brent Kern1, Frederick A. Fletcher1, Asaf Cohen1, Elliot Korach1, Tom Ulich1, Ian McNiece2, Pamela Lockbaum1, Mary Ann Miller‐Messana1, Sheila Gardner1, Thomas R. Hunt3, G Schwab1
1Departments of Pharmacology, Pharmaceutics and Clinical Development, Amgen Inc., Thousand Oaks, CA USA
2University Hospital, Bone Marrow Transplant Program, Denver, CO USA
3PPD Pharmaco, Austin, TX, USA

Tóm tắt

Từ khóa


Tài liệu tham khảo

Welte K, Gabrilove J, Bronchud MH, Platzer E, Morstyn G (1996) Filgrastim (r-metHuG-CSF): the first 10 years. Blood 88:1907

Bronchud, 1987, Phase I/II study of recombinant human granulocyte colony-stimulating factor in patients receiving intensive chemotherapy for small cell lung cancer, Br J Cancer, 56, 809, 10.1038/bjc.1987.295

Ulich, 1988, Kinetics and mechanisms of recombinant human granulocyte-colony stimulating factor-induced neutrophilia, Am J Pathol, 133, 630

Tanaka, 1991, Pharmacokinetics of recombinant human granulocyte colony-stimulating factor in the rat. Single and multiple dosing studies, Drug Metab Dispos, 19, 200

Roskos, 1998, Pharmacology of filgrastim (r-metHuG-CSF), 51

Tanaka, 1991, Pharmacokinetics of recombinant human granulocyte colony-stimulating factor conjugated to poly(ethylene glycol) in rats, Cancer Res, 51, 3710

Delgado C, Francis GE, Fisher D (1992) The uses and properties of PEG-linked proteins.

(1998) In: G Morstyn, TM Dexter, MA Foote (eds) Filgrastim in clinical practice, 2nd edition. New York: Marcel Dekker.

Molineux, 1990, A comparison of hematopoiesis in normal and splenectomized mice treated with granulocyte colony-stimulating factor, Blood, 75, 563, 10.1182/blood.V75.3.563.563

Welte, 1988, Recombinant human granulocyte-colony stimulating factor, Behring Inst Mitt, 83, 102

Molineux, 1995, Continuous subcutaneous infusion of hematopoietic growth factors in mice, Exper Hematol, 23, 880

Schwab, 1998, A phase I study of sustained-duration filgrastim in normal volunteers, Exper Hematol, 26, 709

Roskos, 1999, A cytokinetic model describes the granulopoietic effects of r-metHuG-CSF-SD/01 (SD/01) and the homeostatic regulation of SD/01 clearance in normal volunteers, Clin Pharmacol Ther, 65, 196, 10.1016/S0009-9236(99)80315-4

Cheung, 1998, Modelling of r-metHuG-CSF-SD/01 (SD/01) mediated granulopoiesis in normal animals with mathematical extrapolation to neutropenic settings, Blood, 92, 379A

Roskos, 1998, Cytokinetic model of rmethHuG-CSF-SD/01 (SD/01) mediated granulopoiesis and the and the “self-regulation” of SD/01 elimination in non-small cell lung cancer (NSCLC), Blood, 92, 507A

Mast, 1990, Evaluation of the rapid plasma elimination of recombinant alpha1-proteinase, J Lab Clin Med, 116, 58

Tanaka, 1990, Influence of renal and hepatic failure on the pharmacokinetics of recombinant human granulocyte colony-stimulating factor (KRN8601) in the rat, Cancer Res, 50, 6615

Molineux, 1996, Megakaryocyte growth and development factor accelerates platelet recovery in peripheral blood progenitor cell transplant recipients, Blood, 88, 366, 10.1182/blood.V88.1.366.366

Molineux, 1997, An analysis of the effects of combined treatment with rmGM-CSF and PEG-rHuMGDF in murine bone marrow transplant recipients, Stem Cells, 15, 43, 10.1002/stem.150043

de Haan, 1994, Mutual inhibition of murine erythropoiesis and granulopoiesis during combined erythropoietin, granulocyte colony-stimulating factor, and stem cell factor administration, Blood, 84, 4157, 10.1182/blood.V84.12.4157.bloodjournal84124157

Molineux, 1997, An analysis of the effects of combined treatment with rmGM-CSF and PEG-rHuMGDF in murine bone marrow transplant recipients, Stem Cells, 15, 1, 10.1002/stem.150043

Molineux, 1990, Transplantation potential of peripheral blood stem cells induced by granulocyte colony-stimulating factor, Blood, 76, 2153, 10.1182/blood.V76.10.2153.2153

Lane, 1999, Mobilization of blood-derived stem and progenitor cells in normal subjects by granulocyte-macrophage- and granulocyte-colony-stimulating factors, Transplantation, 39, 39

Baumann, 1996, Mobilisation kinetics of primitive haemopoietic cells following G-CSF with or without chemotherapy for advanced breast cancer, Ann Oncol, 7, 1051, 10.1093/oxfordjournals.annonc.a010498

Lord, 1994, Haemopoietic progenitor and myeloid cell kinetics in humans treated with interleukin-3 and granulocyte/macrophage colony-stimulating factor in combination, Int J Cancer, 59, 483, 10.1002/ijc.2910590409

Lord, 1991, Myeloid cell kinetics in mice treated with recombinant interleukin-3,granulocyte colony-stimulating factor (CSF), or granulocyte-macrophage CSF in vivo, Blood, 77, 2154, 10.1182/blood.V77.10.2154.2154

Capdeville, 1997, A single injection of RO 25-8315, a long-acting pegylated G-CSF mutein, is safe and effective in mobilizing peripheral blood progenitor cells (PBPC) in healthy volunteers. A clinical pharmacology phase I study, Bone Marrow Transplant, 19, S12

Xu, 1997, Safety/tolerability and pharmacokinetics/pharmacodynamics (PK/PD) following administration of ascending subcutaneous doses of a long-acting (5-7 days), chemically modified G-CSF mutein (Ro 25-8315) to healthy subjects, Proc ASCO, 16, 87a

Farese, 1998, A single administration of r-metHuG-CSF-SD/01 (SD/01) significantly improves neutrophil recovery following autologous bone marrow transplantation, Blood, 92, 112A