Abstract

Background/Aims: This study characterized the safety and pharmacological properties of AVI-005, a novel glycosylated recombinant human interferon-a2b 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-a2b (Intron A). The pharmacokinetic parameters t1/2, tmax, Cmax, AUC0-24h, Vd, and clearance were compared between AVI-005 and unglycosylated IFN-a2b. Results: At equipotent doses, AVI-005 had a larger AUC0-24h than the control interferon. Pharmacodynamic markers of neopterin and b2-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 pharmacokinetic properties in humans that support further development.

Author Details

Authors

• T.B. Patel
• E. Pequignot
• S.H. Parker
• M.C. Leavitt
• H.E. Greenberg
• W.K. Kraft

Departments

• ¹ Department of Pharmacology and Experimental Therapeutics, Thomas Jefferson University, Philadelphia, PA, and
• ² AviGenics, Athens, GA, USA

Address

W. Kraft, MD, MS, FACP; Department of Pharmacology and Experimental Therapeutics, Thomas Jefferson University, 132 South 10th Street, 1170 Main Building, Philadelphia, PA 19107, USA
Email: [email protected]

Citation