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Blood, 15 September 2006, Vol. 108, No. 6, pp. 1830-1834. Prepublished online as a Blood First Edition Paper on May 23, 2006; DOI 10.1182/blood-2006-04-015818. This Article Full Text (PDF) All Versions of this Article: blood-2006-04-015818v1 108/6/1830    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Stead, R. B Articles by Duliege, A.-M. Search for Related Content PubMed PubMed Citation Articles by Stead, R. B Articles by Duliege, A.-M. Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted April 11, 2006 Accepted April 25, 2006 Evaluation of the safety and pharmacodynamics of HematideTM, a novel erythropoietic agent, in a phase 1, double-blind, placebo-controlled, dose escalation study in healthy volunteers Richard B Stead, John Lambert, Dawie Wessels, Julie S Iwashita, Kerstin K Leuther, Kathryn W Woodburn, Peter J Schatz, Douglas M Okamoto, Robert Naso, and Anne-Marie Duliege* BioPharma Consulting Services LLC, Bellevue, WA PAREXEL, London, UK Affymax, Inc., Palo Alto, CA Clinimetrics, San Jose, CA * Corresponding author; email: duliege{at}affymax.com. HematideTM is an investigational PEGylated synthetic peptide that stimulates erythropoiesis in animal models and is being developed for the treatment of anemia associated with chronic renal failure and cancer. This study evaluated the safety and pharmacodynamics of single, intravenous doses (0.025, 0.05, and 0.1 mg/kg) of Hematide in 28 healthy male volunteers. All doses of Hematide were well tolerated, with safety profiles similar to that of placebo. Hematide showed a dose- dependent increase in reticulocytes. The 0.1 mg/kg dose was associated with a statistically significant increase in hemoglobin (Hgb) from baseline compared to the placebo group (1.36 ± 0.39 vs. 0.39 ± 0.38 g/dL; p < 0.0001) that was sustained for more than 1 month. These results support Phase 2 studies in patients with anemia associated with chronic kidney disease or cancer, and suggest that Hematide administered as infrequently as once a month may result in a sustained elevation of Hgb levels. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: S. Summers, S. Holdsworth, and E. Sharples The (re-)challenging question of erythropoiesis-stimulating agents inducing pure red cell aplasia Nephrol. Dial. Transplant., June 16, 2008; (2008) gfn326v1. [Full Text] [PDF] I. C. Macdougall Novel Erythropoiesis-Stimulating Agents: A New Era in Anemia Management Clin. J. Am. Soc. Nephrol., January 1, 2008; 3(1): 200 - 207. [Abstract] [Full Text] [PDF] S. Woo, W. Krzyzanski, A.-M. Duliege, R. B. Stead, and W. J. Jusko Population Pharmacokinetics and Pharmacodynamics of Peptidic Erythropoiesis Receptor Agonist (ERA) in Healthy Volunteers J. Clin. Pharmacol., January 1, 2008; 48(1): 43 - 52. [Abstract] [Full Text] [PDF] W. Jelkmann Recombinant EPO production points the nephrologist should know Nephrol. Dial. Transplant., October 1, 2007; 22(10): 2749 - 2753. [Full Text] [PDF] D. W. Grabe Update on clinical practice recommendations and new therapeutic modalities for treating anemia in patients with chronic kidney disease Am. J. Health Syst. Pharm., July 1, 2007; 64(13_Supplement_8): S8 - S14. [Abstract] [Full Text] [PDF] H. F. Bunn New agents that stimulate erythropoiesis Blood, February 1, 2007; 109(3): 868 - 873. [Abstract] [Full Text] [PDF]

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