Phase II Study Of Humanized Anti-IL-4 Antibody Initiated.(Brief Article)

2001 NOV 7 - (NewsRx.com & NewsRx.net) -- Protein Design Labs, Inc. (PDL) announced the start of a Phase II clinical trial to evaluate its humanized antibody to interleukin-4 (IL-4) in asthma.

The randomized, double-blind, placebo-controlled study will be conducted in the United States in 120 symptomatic asthma patients who are not being treated with controller medications including inhaled steroids, leukotriene modifiers, or long-acting beta agonists. Following a run-in period of two weeks' duration

to confirm disease activity, patients will be randomized to one of two dosing regimens of humanized anti-IL-4 antibody or placebo. Patients will receive three, monthly intravenous infusions with a four-month follow-up period. The primary goals of the study are to determine safety, tolerability and preliminary efficacy.

Interleukin-4 is believed to be an important mediator of asthma and allergic diseases. Blockade of IL-4 could potentially inhibit the cellular pathways that lead to the production of other inflammatory cytokines and immunoglobulin E (IgE) antibodies, which are important in the development of asthma. The humanized anti-IL-4 antibody is a high-affinity, neutralizing antibody, which has been demonstrated to competitively block binding of IL-4 to its receptor and to inhibit the synthesis of IgE antibodies in vitro.

"The rationale for studying this population is to determine whether our humanized anti-IL-4 antibody can be safely administered and ...