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Updated: Jul 15, 2026
07:21
Production of Adeno-Associated Virus Vectors in Cell Stacks for Preclinical Studies in Large Animal Models
Published on: June 30, 2021
Transgenic avian-derived recombinant human interferon-alpha2b (AVI-005) in healthy subjects: an open-label,
T B Patel1, E Pequignot, S H Parker
1Department of Pharmacology and Experimental Therapeutics, Thomas Jefferson University, Philadelphia, PA 19107, USA.
Summary
AVI-005, a novel glycosylated interferon-alpha2b, showed promising safety and pharmacokinetic properties in healthy volunteers. This new interferon demonstrated biological activity, supporting its further clinical development.
Area of Science:
- Biotechnology
- Pharmacology
- Immunology
Background:
- Introduction of AVI-005, a novel glycosylated recombinant human interferon-alpha2b.
- Production of AVI-005 using chicken egg white transgenic technology.
Purpose of the Study:
- Characterize the safety and pharmacological properties of AVI-005 in humans.
- Compare AVI-005 with unglycosylated interferon-alpha2b (Intron A).
Main Methods:
- 18 healthy volunteers received single subcutaneous doses of AVI-005.
- 10 subjects received unglycosylated interferon-alpha2b (Intron A) as a comparator.
- Pharmacokinetic parameters (t1/2, tmax, Cmax, AUC0-24h, Vd, clearance) were analyzed.
Main Results:
- AVI-005 exhibited a larger AUC0-24h compared to the control interferon at equipotent doses.
- Pharmacodynamic markers (neopterin, beta2-microglobulin) increased dose-dependently with AVI-005.
- Adverse events were similar between AVI-005 and the control interferon.
Conclusions:
- AVI-005 demonstrates significant biological activity in humans.
- The pharmacokinetic profile of AVI-005 supports its further development.
- AVI-005 shows a safety profile comparable to existing interferon therapies.
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