+ + data and comment + +, page-11

re: + + phase iib trial commences + For release: 6 November 2003
Phase 2B Clinical Trial commences

"Metabolic is pleased to announce that patient recruitment on its Phase 2b clinical trial of
obesity drug AOD9604 is well under way. We believe this to be the largest clinical trial undertaken by an Australian biotech company.

The trial is being conducted at five clinical trial sites across Adelaide, Melbourne (2 sites), Sydney and Brisbane.

Supplies of AOD9604 have been delivered to all sites and screening and preparation of subjects is well under way. The first enrolled patients are expected to begin treatment in the next few days.

Metabolic has a very large database of hopeful participants, following an overwhelming response to an item aired on Channel Nine’s A Current Affair recently.

Primary Aim
The primary aim of the study is to evaluate the extent of weight loss achieved with AOD9604 treatment compared to placebo, with trial participants subjected to daily oral dosing over a three month period.

Other parameters of interest to be measured include fat
mass, blood cholesterol, glucose metabolism and perceived quality of life.

Trial Design
Three hundred obese but otherwise healthy people will participate in this groundbreaking trial.
The 300 trial subjects will be made up of men and women aged 30 to 65 years with a body mass index (or BMI, being weight in kg divided by the square of height in metres) of 35 or higher.

This number of trial subjects has been chosen to ensure that a statistically significant difference between treatment and placebo groups is possible at the conclusion of the trial for all useful amounts of weight loss (i.e. at or above the amount achieved by
existing weight loss drugs).

Medication will consist of capsules containing a daily dose of AOD9604 or placebo in either 0mg (placebo), 1mg, 5mg, 10mg, 20mg, or 30mg quantities. There will be 50 subjects in each dose group.

Phase 2a oral dosing trials already completed on AOD9604 (a single dose trial and a one-week multiple-dose trial) have indicated that this range of doses will cover the likely optimum dose, with strongest effects previously seen at the 10 mg dose".