Abstract:
:Hematide 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 those 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 (13.6 +/- 3.9 g/L [1.36 +/- 0.39 g/dL] versus 3.9 +/- 3.8 g/L [0.39 +/- 0.38 g/dL]; P < .001) that was sustained for longer 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. (Please note that Hematide is a proposed trade name; the compound does not yet have a nonproprietary name.).
journal_name
Bloodjournal_title
Bloodauthors
Stead RB,Lambert J,Wessels D,Iwashita JS,Leuther KK,Woodburn KW,Schatz PJ,Okamoto DM,Naso R,Duliege AMdoi
10.1182/blood-2006-04-015818subject
Has Abstractpub_date
2006-09-15 00:00:00pages
1830-4issue
6eissn
0006-4971issn
1528-0020pii
blood-2006-04-015818journal_volume
108pub_type
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