Journal of Allergy and Clinical Immunology
Volume 113, Issue 2, Supplement 1 , February 2004, Pages S222-S223
Program and Abstracts of papers presented during Scientific Sessions -
AAAAI 60th Annual Meeting

doi:10.1016/j.jaci.2004.01.253
Copyright © 2004 American Academy of Allergy, Asthma and Immunology.
Published by Mosby, Inc.
Abstract
Oral recombinant human lactoferrin (RhLF) in a non-human primate model
of asthma*1

M. van Scotta, P. Glynnb and A. Varadhacharyb

a East Carolina University, Greenville, NC, USA
b Agennix Inc., Houston, TX, USA

Available online 19 February 2004.

Abstract
Rationale
RhLF is an anti-inflammatory and immunomodulatory protein previously
demonstrated to block early and late phase asthmatic responses (EAR,
LAR) and delayed airway hypersensitivity (DAH) to allergen in a sheep
model of asthma. In this study, we evaluated the efficacy and dose
range of rhLF in a primate model of asthma.

Methods
Dust mite-sensitized cynomolgus monkeys were administered liquid rhLF
or placebo orally once per day for 14 days. Early phase changes in
airway resistance (Raw) and dynamic compliance (Cdyn), and cellular
composition of bronchoalveolar lavage fluid (BALF) 48-hours after
challenge were measured.

Results
Oral rhLF inhibited up to 75% of the allergen-induced increase in Raw
and decrease in Cdyn at doses between 9 and 80 mg rhLF/kg body weight,
with partial inhibition at 3 mg/kg. Eosinophilic infiltration of BALF
was reduced up to 60% at doses as low as 0.3 mg/kg. In pilot
experiments, rhLF also abolished LAR and DAH and prevented a drop in
oxygen saturation following allergen challenge.

Conclusion
Oral rhLF inhibits bronchoconstriction and cellular infiltration in a
nonhuman primate model of asthma and holds promise as a novel
therapeutic agent for asthmatics. RhLF has been shown to be safe and
well tolerated in humans and is currently being tested in a Phase II
clinical trial in patients with mild to moderate asthma.

*1 Funding: Agennix Inc.

Journal of Allergy and Clinical Immunology
Volume 113, Issue 2, Supplement 1 , February 2004, Pages S222-S223
Program and Abstracts of papers presented during Scientific Sessions -
AAAAI 60th Annual Meeting

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http://www.pdrhealth.com/drug_info/nmdrugprofiles/nutsupdrugs/lac_0314.shtml

ACTIONS AND PHARMACOLOGY
ACTIONS
Supplemental lactoferrin may have antimicrobial, immunomodulatory,
antioxidant and anti-inflammatory actions.

MECHANISM OF ACTION
The possible antibacterial activity of supplemental lactoferrin might
be accounted for, in part, by its ability to strongly bind iron. Iron
is essential to support the growth of pathogenic bacteria. Lactoferrin
may also inhibit the attachment of bacteria to the intestinal wall. A
breakdown product of lactoferrin is the peptide lactoferricin.
Lactoferricin, classified as a bioactive peptide, may also have
antibacterial, as well as antiviral, activity. The possible antiviral
activity of supplemental lactoferrin may be due to its inhibition of
virus-cell fusion and viral entry into cells.

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