MBP 3.23% 3.0¢ metabolic pharmaceuticals limited

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    Investor update Sept. 2003-Date 30 Sept.:

    http://stocknessmonster.com/news-item?S=MBP&E=ASX&N=209513

    We are pleased to provide this update on the company’s activities:
    • AOD9604 Phase 2b human clinical trial commencement on track
    • New analgesic compound ACV1 in-licensed
    • Progress on other projects
    Note: Metabolic's 2003 Annual Report is being released today. The Company has also lodged with the ASX a separate announcement on its in-licensing of ACV1.

    1. AOD9604 Obesity Drug
    Preparations are on track for commencement of the Company’s 300 patient Phase 2b human clinical trial of AOD9604 obesity drug, with the first patients expected to commence treatment in late-October.

    The double-blind placebo-controlled trial involves the participation of five leading Australian hospitals. The primary aim of the study is to assess weight loss after three months daily dosing in male and female obese subjects.

    Ethics approval at the five clinical trial sites has been obtained, with final documentation completed at three sites and the other two imminent. Patient screening has formally commenced at one site, with the first patients are expected to commence treatment by late-October.

    Metabolic also announced on 22 September the formation of a US Clinical Advisory Panel, comprising three eminent US research clinicians on obesity. The role of the panel is to advise and consult with Metabolic on the further clinical development of obesity
    drug AOD9604.

    In August 2003 the Industry Research and Development Board approved a grant to Metabolic of up to $2.1 million in dollar-for-dollar funding under the Commonwealth Government’s R&D START Program. Funds will be used in the conduct of the
    Company’s Phase 2b clinical trial of AOD9604.

    2. New analgesic compound ACV1 in-licensed
    The Company is pleased to announce the in-licensing of an exciting new analgesic compound called ACV1, which was discovered by Associate Professor Bruce Livett and
    fellow scientists associated with the University of Melbourne.

    Because of the success and advanced stage of efficacy testing already performed on the
    compound, Metabolic will accelerate the commencement of a pre-clinical toxicity
    program.
    In terms of development being undertaken by Metabolic, ACV1 now sits second behind AOD9604. Metabolic has the exclusive worldwide license to commercialise ACV1.
    A separate detailed announcement has been made today on this project.

    3. Progress on other projects
    MBP0250/0260 for osteoporosis MBP0250 and MBP0260 are peptide fragments of the hormones amylin and
    adrenomedullin respectively, invented by Prof. Ian Reid and Assoc. Prof. Jillian Cornish at the Auckland University Bone Research Group.

    They are being developed primarily for the treatment of osteoporosis and in March 2002 were exclusively licensed to Metabolic from Auckland Uniservices Ltd.
    The Auckland researchers have found that both compounds can be dosed to high levels in rodents without apparent ill effect and show bone building effects on one daily subcutaneous dosing of a similar magnitude to PTH, the major competing class of bone
    anabolic compounds in research.

    Since activating this project in March 2002, Metabolic has embarked on a program of further preclinical assessment of MBP0250 and MBP0260 in animal models of osteoporosis and other bone models. These studies have so far identified the likely dose range over which bone building activity is observed, and further experiments are being performed to provide confirmation.

    We aim to have accumulated sufficient animal efficacy data by early 2004 to provide a decision point on whether to advance one of MBP0250 and MBP0260 to preclinical safety studies in preparation for clinical trials.
    ADD9918/9922 for type 2 diabetes.

    These compounds are analogs (slight modifications) of a functional-region of the human insulin molecule. They have been found to alleviate diabetic conditions in animal models and are under assessment by Metabolic as potential treatments for type 2 diabetes.

    Scientists at the Metabolic laboratory have made progress on identifying the likely cause of inconsistent results from some experiments performed in the previous year. The cause appears to relate to manufacturing specifications, and further in vivo experiments will commence soon on new batches of compound.

    Once the previous encouraging in vivo results are reproduced, the process of selection of a lead candidate will resume.

    An international patent application filed in March 2001 has passed preliminary examination and entered national phase.

    MBP0201 for iron overload.
    MBP0201 is an iron chelator compound for the treatment of iron overload conditions.
    The project was exclusively licensed from Sydney’s Heart Research Institute in March 2002.

    The compound has been shown to enhance the excretion of iron in laboratory rodents after oral administration, and is being assessed by Metabolic for its potential as an orally-dosed treatment for iron overload disorders such as beta-thalassemia, sickle cell
    anemia and hereditary hemochromatosis.

    In August 2002 the Industry Research and Development (IR&D) Board approved a grant to Metabolic under the Biotechnology Innovation Fund for this project, providing up to $234,700 in dollar-for-dollar funding over two years.
    Testing of the efficacy and tolerability of MBP0201 in animal models of iron overload is currently in progress. These tests are expected to be complete in late 2003 when a decision on the further development of MBP0201into formal toxicity tests will be made.

    4. Next Update
    The next update will be provided in late October at commencement of dosing in the Phase 2b clinical trial of obesity drug AOD9604.

    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, pain, type 2 diabetes, osteoporosis and iron overload.

    AOD9604 for obesity is the company’s most advanced project, currently in Phase 2 human clinical trials. It is a peptide analogue of a fragment of human growth hormone which Metabolic believes has the potential to provide a safer and more effective pharmaceutical treatment for obesity.

    The drug, discovered by scientists at Monash
    University, reduces body fat by mimicking natural hormonal regulation of fat metabolism.
 
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