The clinical potential of novel erythropoiesis stimulating protein

Bibliography

• JACOBSON LO, GOLD WASSER E, FRIED W, PLZAK L: Role of the kidney in erythropoiesis. 1957 [classical article]. Am. Soc. NephroL (2000) 11:589-590 (discussion 589–592).
   Google Scholar
• ERSLEV AJ, BESARAB A: Erythropoietin in the pathogenesis and treatment of the anemia of chronic renal failure [editorial]. Kidney Int. (1997) 51:622–630.
   PubMed Web of Science ®Google Scholar
• KOURY MJ, BONDURANT MC: Erythropoietin retards DNA breakdown and prevents programmed death in erythroid progenitor cells. Science (1990) 248:378–381.
   PubMed Web of Science ®Google Scholar
• ALFREY CP, RICE L, UDDEN MM, DRISCOLL TB: Neocytolysis: physiological down-regulator of red-cell mass. Lancet (1997) 349:1389–1390.
   PubMed Web of Science ®Google Scholar
• RICE L, ALFREY CP, DRISCOLL T, WHITLEY CE, HACHEY DL, SUKI W: Neocytolysis contributes to the anemia of renal disease. Am. I Kidney Dis. (1999) 33:59–62.
   PubMed Web of Science ®Google Scholar
• LIN FK, SUGGS S, LIN CH et al.: Cloning and expression of the human erythropoietin gene. Proc. Natl. Acad .Sci. USA (1985) 82:7580–7584.
   PubMed Web of Science ®Google Scholar
• ESCHBACH JW, EGRIE JC, DOWNING MR, BROWNE JK, ADAMS ON JW: Correction of the anaemia of end-stage renal disease with recombinant human erythropoietin. Results of a combined Phase I and II clinical trial. N ErigL j Med. (1987) 316:73–78.
   Google Scholar
• WINEARLS CG, OLIVER DO, PIPPARD MJ, REID C, DOWNING MR, COTES PM: Effect of human erythropoietin derived from recombinant DNA on the anaemia of patients maintained by chronic haemodialysis. Lancet (1986) 2:1175–1178.
   PubMed Web of Science ®Google Scholar
• WORKING PARTY FOR EUROPEAN BEST PRACTICE GUIDELINES FOR THE MANAGEMENT OF ANAEMIA IN PATIENTS WITH CHRONIC RENAL FAILURE: European best practice guidelines for the management of anaemia in patients with chronic renal failure. NephroL Dial. Transplant (1999) 14\(Suppl. 5):1–50.
   Google Scholar
• WEISS LG, CLYNE N, FIHLHO JD, FRISENETTE-FICH C, KURKUS J, SVENSSON B: The efficacy of once weekly compared with two or three times weekly subcutaneous epoetin 13 results from a randomized controlled multicentre trial. NephroL Dial. Transplant (2000) 15:2014–2019.
   PubMed Web of Science ®Google Scholar
• DORDAL MS, WANG FF, GOLDWASSE E: The role of carbohydrate in erythropoietin action. Endocrinology (1985) 116:2293–2299.
   PubMed Web of Science ®Google Scholar
• EGRIE JC, GRANT JR, GILLIES DK, AOKI KH, STRICKLAND TW: The role of carbohydrate on the biological activity of erythropoietin. Clycocorgugate J. (1993) 10:263A.
   Web of Science ®Google Scholar
• ELLIOTT SG, LORENZINI T, STRICKLAND T, EGRIE JC: Rational design of novel erythropoiesis stimulating protein (ARANESP): a super-sialated molecule with increased biological activity. Blood (2000) 96:82A–83A.
   Google Scholar
• FORST I: Analysis. Amgen's NESP victory cuts out Johnson & Johnson. Nature Biotech. (1999) 17:124.
   Google Scholar
• EGRIE JC, DWYER E, LYKOS M, HITZ A, BROWNE JK: Novel erythropoiesis stimulating protein (NESP) has a longer serum half-life and greater in vivo biological activity compared to recombinant human erythropoietin (rHuEPO). Blood (1997) 90:56A–57A.
   Google Scholar
• EGRIE JC, BROWN JK: Development and characterization of novel erythropoiesis stimulating protein (NESP). NephroL Dial. Transplant. (2001) 16\(Suppl. 3):3–13.
   Google Scholar
• EGRIE JC, BROWNE JK: Development and characterization of novel erythropoiesis stimulating protein (NESP). Br j Cancer (2001) 84 (Suppl. 8a):3–10.
   Google Scholar
• MACDOUGALL IC: Novel Erythropoiesis Stimulating Protein (NESP) for the treatment of renal anemia. j Am. Soc. NephroL (1998) 9:258A–259A.
   Google Scholar
• ••The first dose finding studies for NESP arereported.
   Google Scholar
• MACDOUGALL IC, GRAY SJ, ELSTON 0 etal.: Pharmacokinetics of novel erythopoiesis stimulating protein compared with Epoetin Alfa in dialysis patients. J. Am. Soc. NephroL (1999) 10:2392–2395.
   Google Scholar
• ••For the first time it is shown that NESPhas a 3-fold prolonged terminal elimination time as compared with rhuEPO.
   Google Scholar
• MACDOUGALL IC: Novel erythropoiesis stimulating protein. Smith. Nephrol. (2000) 20:375–381.
   PubMed Web of Science ®Google Scholar
• ALLON M, KLEINMAN K, WALCZYK M et al.: The pharmacokinetics of novel erythropoiesis stimulating protein (NESP) following chronic intravenous administration is time- and dose-linear. J. Am. Soc. Nephrol. (2000) 11:248A.
   Google Scholar
• LERNER GR, KALE AS, WARADY BA et al.: The pharmacokinetics of Novel erythropoiesis stimulating protein (NESP) in pediatric patients with chronic renal failure (CRF) or end-stage renal disease. J. Am. Soc. Nephrol. (2000) 11:282A.
   Google Scholar
• GLASPY J, COLOWICK A, HEATHERINGTON A: Novel erythropoiesis stimulating protein (NESP) exhibits a prolonged serum half life (T112) in oncology patients (Pts). American Society of Clinical Oncology (2000) 36th Annual meeting:210A.
   Google Scholar
• LOCATELLI F, OLIVARES J, WALKER R, WILKIE M: Novel erythropoiesis stimulating protein (NESP) administered subcutaneously corrects anemia in subjects with chronic renal insufficiency (CRI) when administered at a reduced dose frequency compared with recombinant-human Erythropoietin (r-HuEPO). J. Am. Soc. Nephrol. (2000) 11:283A.
   PubMedGoogle Scholar
• COYNE DW, LING BN, TOTO R, MCDERMOTT-VITAK AD, TROTMAN ML, JACKSON L: Novel erythropoiesis stimulating protein (NESP) corrects anemia in dialysis patients when administered at reduced dose frequency compared with recombinant human erythropoietin (r- HuEPO). J Am. Soc. Nephrol. (2000) 11:263A.
   Google Scholar
• VANRENTERGHEM Y, BARANY P, MANN J: Novel erythropoiesis stimulating protein (NESP) maintains hemoglobin in ESRD patients when administered once-weekly or once every other week. J. Am. Soc. Nephrol. (1999) 10:270A.
   Google Scholar
• ••First long-term study with NESP fortreatment of renal anaemia. This pivotal Phase III study shows that NESP and rhuEPO have a similar effect on haemoglobin levels in chronic hemodialysis patients.
   Google Scholar
• NISSENSON AR, SWAN SK, LINDBERG JS et al.: Novel erythropoiesis stimulating protein (NESP) safely maintains hemoglobin concentration levels in hemodialysis patients as effectively as r-HuEPO when administered once weekly. J. Am. Soc. Nephrol. (2000) 11:252A.
   Google Scholar
• ••This pivotal placebo controlled Phase IIIstudy also shows that the adverse events are not different among NESP- or rhuEPO-treated dialysis patients.
   Google Scholar
• THE EUROPEAN/AUSTRALIAN NESP 980140/194 STUDY GROUP: Novel erythropoiesis stimulating protein (NESP) effectively maintains hemoglobin (Hgb) when administered at a reduced dose frequency compared with recombinant human erythropoietin (r-HuEPO) in dialysis patients. J. Am. Soc. Nephrol. (2000) 11:250A.
   PubMedGoogle Scholar
• MACDOUGALL IC: An overview of theefficacy and safety of novel erythropoiesis stimulating protein (NESP). Nephrol. Dial. Transplant. (2001) 16 (Suppl. 3):14–21.
   Google Scholar
• ALJAMA P, BOMMER J, CANAUD Bet al. (The NESP Usage Guidelines Group): Practical guidelines for the use of NESP in treating renal anaemia. Nephrol. Dial. Transplant. (2001) 16 (Suppl. 3):22–28.
   Google Scholar
• HEATHERINGTON AC, SCHULLER J, MERCER AJ: Pharmacokinetics of novel erythropoiesis stimulating protein (NESP) in cancer patients: preliminary report. Br. J. Cancer (2001) 84(Suppl 8a):11–16.
   Google Scholar
• GLASPY J, JADEJA JS, JUSTICE G etal.: A dose-finding and safety study of novel erythropoiesis stimulating protein (NESP) for the treatment of anaemia in patients receiving multicycle chemotherapy. Br J. Cancer (2001) 84(Suppl 8a):17–23.
   Google Scholar
• SMITH RE, JAIYESIMI IA, MEZA LA et al.: Novel erythropoiesis stimulating protein (NESP) for the treatment of anaemia of chronic disease associated with cancer. Br J. Cancer (2001) 84(Suppl 8a):24–30.
   Google Scholar
• DEMETRI GD: Anaemia and its functional consequences in cancer patients: current challenges in management and prospects for improving therapy. Br J. Cancer (2001) 84(Suppl 8a):31–37.
   Google Scholar