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www.fdanews.com/articles/63545-tanox-begins-trial-of-anti-il-13-agent-for-treating-asthma

TANOX BEGINS TRIAL OF ANTI-IL-13 AGENT FOR TREATING ASTHMA

October 30, 2006

Tanox has begun dosing in a Phase I clinical trial of TNX-650, a humanized monoclonal antibody being evaluated as a potential treatment for moderate-to-severe asthma.

The trial is a randomized, double-blind, placebo-controlled, dose-escalation study of the safety, tolerability and pharmacokinetics of single doses of TNX-650 in healthy volunteers. A total of 32 subjects will be enrolled in four cohorts in the study, which is being conducted at a single site in the U.S.

TNX-650 targets Interleukin 13 (IL-13). Preclinical studies indicate that IL-13 is a key mediator of asthma responses, including airway inflammation, obstruction and hyper-reactivity. TNX-650, which has a mechanism of action different from currently available asthma treatments, has the potential to be a therapeutic option for patients whose disease is not well-controlled and for non-allergic asthmatics.

Tanox is also evaluating the anti-IL-13 effect of TNX-650 as a potential treatment for Hodgkin's lymphoma in an ongoing Phase I clinical trial.