Document Type
Article
Publication Date
3-1-2007
Abstract
BACKGROUND/AIMS: This study characterized the safety and pharmacological properties of AVI-005, a novel glycosylated recombinant human interferon-alpha2b produced from the egg whites of chickens transfected with human cDNA.
METHODS: 18 healthy volunteers received single subcutaneous rising doses (0.5, 1.66 or 5 million international units, MIU) of AVI-005. A randomized parallel comparator group of 10 subjects received 5 MIU of unglycosylated IFN-alpha2b (Intron A). The pharmacokinetic parameters t1/2, tmax, Cmax, AUC0-24h, Vd, and clearance were compared between AVI-005 and unglycosylated IFN-alpa2b.
RESULTS: At equipotent doses, AVI-005 had a larger AUC0-24h than the control interferon. Pharmacodynamic markers ofneopterin and beta2-microglobulin for the two treatments were similar. These markers were increased by AVI-005 in a dose-dependent manner. Pharmacodynamic responses to treatment with AVI-005 were shown by the change in mRNA expression for interferon inducible protein kinase and 2'5'-oligoadenylate synthetase. Adverse events in the two groups were qualitatively and quantitatively similar.
CONCLUSION: AVI-005 demonstrates biological activity and pharmaco-kinetic properties in humans that support further development.
Recommended Citation
Patel, T B; Pequignot, E; Parker, S H; Leavitt, M C; Greenberg, H E; and Kraft, Walter K., "Transgenic avian-derived recombinant human interferon-alpha2b (AVI-005) in healthy subjects: an open-label, single-dose, controlled study." (2007). Department of Pharmacology and Experimental Therapeutics Faculty Papers. Paper 29.
https://jdc.jefferson.edu/petfp/29
PubMed ID
17416111
Comments
This article has been peer reviewed. It is the authors' final version prior to publication in International Journal of Clinical Pharmacology and Therapeutics
Volume 45, Issue 3, March 2007, Pages 161-168.
The published version is available at PubMed ID: 17416111. Copyright © Dustri-Verlag