MBP 3.23% 3.0¢ metabolic pharmaceuticals limited

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    re: + + completion of aod9604 clinical trial recr Metabolic announces completion of recruitment in
    Phase 2b AOD9604 obesity trial
    For Release: 2 June 2004

    We are pleased to advise that full recruitment has now been achieved for Metabolic’s 300-patient Phase 2b clinical trial on obesity drug AOD9604. Over one third of the patients have now finished treatment.

    The last patient is expected to finish treatment in
    September 2004, with reportable results of the trial available by late November 2004.
    “This is the largest clinical trial undertaken by an Australian biotech company, and the completion of recruitment is an important milestone for the company”, said Chris Belyea, CEO of Metabolic.

    “We thank the investigators and study staff at the five clinical trial sites for their dedicated efforts in achieving this goal.”

    The Phase 2b trial is a multi-centre, randomized, double-blind, placebo-controlled trial in 300 obese male and female patients. Patient recruitment began in November 2003.

    The patients are obese but otherwise healthy men and women aged between 30 and 65, and are randomized to receive once daily oral doses of either zero (placebo), 1, 5, 10, 20 or 30 mg AOD9604 in capsules, for 12 weeks.

    The primary efficacy endpoints (aims) of the study are to determine the effect of AOD9604 on body weight reduction, and fat reduction measured from a CT scan.
    Secondary endpoints are other measures of obesity (such as waist circumference) and the effect of AOD9604 on perceived quality of life (as reported by a standard questionnaire).

    The current Phase 2b human clinical trial is a definitive test of the efficacy and safety of the drug over 12 weeks. With a positive result, Metabolic intends to enter into a partnership with a major pharmaceutical company to assist in financing Phase 3 human
    clinical trials for worldwide marketing approval as a prescription treatment.

    About AOD9604
    The AOD9604 molecule is a small orally active peptide modelled on one part of the human growth hormone molecule. Growth hormone naturally occurs in the body and has profound stimulatory effects on fat metabolism, with levels of the hormone typically becoming suppressed in the obese state.

    Daily dosing with AOD9604 restores suppressed fat metabolism by mimicking the fat metabolic effects of growth hormone.
    Metabolic believes that AOD9604 has the potential to provide a safer and more effective pharmaceutical treatment for obesity than existing drugs.
    Previous short-term clinical trials conducted on AOD9604, with single doses and multiple doses of up to 1 week’s duration, have indicated that drug is orally active, well tolerated and shows the expected trends in weight loss.

    About obesity
    Obesity has reached epidemic proportions in the Western world, with 30 percent of US adults now classified as obese. The economic costs of obesity due to its adverse health consequences are enormous, with annual health costs being 77 percent higher in obese
    people.

    Existing medications to assist in weight loss have limited efficacy and substantial side effects.

    About Metabolic
    Metabolic Pharmaceuticals Limited is a biotechnology company based in Melbourne, Australia, and listed on the Australian Stock Exchange (ASX: MBP).

    The Company’s mission is to develop a pipeline of new pharmaceuticals for world markets, and currently
    has active programs aimed at treating obesity (AOD9604 in Phase 2b human trials), pain
    (ACV1 in preclinical toxicology), type 2 diabetes, and osteoporosis.

    Further details are available at www.metabolic.com.au.
    Contact Information:
    Ph +61 3 9860 5700
    Chris Belyea CEO [email protected]
    David Kenley VP Corporate Development [email protected]
 
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