BOARD RECOMMENDS CONTINUATION OF TANOX'S HIV DRUG TRIAL

An independent data safety monitoring board (DSMB) has reviewed a planned interim safety analysis of Tanox's Phase II clinical trial of TNX-355 for treatment of HIV and has recommended continuation of the trial.

The board examined all critical safety data specified in the study's protocol. Reliable information was made available for review after the last randomized, dosed patient reached the 20-week time point of the 48-week study. Prespecified stopping criteria, based on a group sequential test for monitoring immunosuppressive effects, were not met and no other safety concerns were cited. In addition, the DSMB did not find cause to change the planned conduct of the trial or to alter the study's current monitoring plan.

The Phase II study is a three-arm, double-blind, placebo-controlled trial evaluating the safety and efficacy of TNX-355, as assessed by viral load reduction. The study, which enrolled 82 patients, is statistically designed to compare the effect of two different dose schedules of TNX-355 added to optimized background therapy (OBT) versus OBT plus placebo in treatment-experienced HIV-infected patients.