MBP 3.23% 3.0¢ metabolic pharmaceuticals limited

Movement at Metabolic

  1. 470 Posts.
    Price up today on moderate (for MBP) vol.

    Given that some announcements are due in August, (see below) this either means that there is a whiff oc success or that buyers are punting on a possible positive outcome of the trials.

    AnnaPMETABOLIC PHARMACEUTICALS LIMITED 2002-05-22 ASX-SIGNAL-G

    HOMEX - Melbourne

    +++++++++++++++++++++++++
    As has been our practice since formation in 1998, Metabolic remains
    committed to providing frequent and detailed updates for investors.
    Following our February update and several subsequent announcements,
    your board is pleased to provide this May update.

    SUMMARY

    * The Phase 2A oral administration clinical trial of AOD9604 obesity
    drug has commenced on schedule and results should be available in
    August;

    * ADD9918 and ADD9922 diabetes compounds are proceeding through
    animal efficacy tests

    * MBP0250 and MBP0260 osteoporosis compound synthesis is nearly
    complete and animal efficacy tests are ready to start;

    * MBP0201 iron chelator compounds have been synthesized and animal
    efficacy experiments are in progress;

    * The company now has cash reserves of $12.6 million through the
    recent placement, the share purchase plan and exercise of options.

    AOD9604 for OBESITY

    ADD9604 is a peptide analog of a fragment of human growth hormone,
    with the potential to provide a safe and effective pharmaceutical
    treatment for obesity.

    The Phase 2A oral human clinical trial of A0D9604 commenced today on
    schedule.

    This is a double-blind single-dose trial of similar design to the
    intravenous trial reported in February which showed very encouraging
    positive results. The purpose of the oral trial is to assess safety
    and activity of AOD9604 administered orally in capsules. Sixteen
    patients will each receive a single oral dose of 0, 9, 36 or 54 mg of
    AOD9604 in random order, on four occasions separated by two-weekly
    intervals.

    The results from this trial should be available in late August.

    If the results show oral activity of AOD9604 in humans, as we expect
    from observations in animals, a multiple dose oral clinical program
    will commence as soon as possible thereafter. This program is planned
    to involve an initial seven-day oral safety study followed by a
    one-month oral weight reduction study. These studies will help
    determine the expected rate of weight loss after daily dosing and the
    optimal dose for pivotal longer term Phase 2/3 studies.

    If the results of the current study show that AOD9604 is not active
    orally in humans, we plan to commence a multi-dose safety study via
    intravenous administration. This would be required to support the
    subsequent human testing of a slow-release depot formulation
    administered once per month by subcutaneous injection. A depot
    formulation would be a feasible and marketable alternative to oral
    delivery.

    ADD9918/ADD9922 for TYPE II DIABETES

    ADD9918 and ADD9922 are analogs of fragments of insulin that cause
    potent insulin sensitization in animal models of type 2 diabetes.
    They have the potential to provide a new treatment for type 2
    diabetes.

    As previously reported, our attentions have narrowed to two candidate
    compounds, codenamed ADD9918 and ADD9922, which produced favourable
    results from preliminary toxicity tests. After conducting comparative
    animal efficacy experiments, the next stage is to select one of these
    two compounds for a full preclinical program.

    These efficacy experiments are underway and while we are obtaining
    useful data, this part of the program is taking longer than expected.
    We anticipate reporting substantial progress in the next quarter.

    MBPO250 and MBF0260 for OSTEOPOROSIS

    MBPO250 and MBPO260 are fragments of the hormones amylin and
    adrenomedullin with potential for the treatment of osteoporosis.
    These compounds were exclusively licensed from the University of
    Auckland in March this year.

    Synthesis of sufficient quantities for animal trials with both
    compounds is nearly complete and contracts to start a pivotal animal
    efficacy experiment are in place. This experiment should finish near
    the end of this year. The objective is to prove bone building in a
    rat model of osteoporosis similar to the bone building in mice
    already reported in published work by the inventors. A positive
    outcome would result in activation of a fall preclinical program on
    the most promising of the in-licensed compounds commencing in early
    2003.

    MBPO201 for IRON OVERLOAD

    MBPO201 is a new compound with potential to provide an effective oral
    drug for iron overload diseases. This invention was exclusively
    licensed from Sydney's Heart Research Institute in March this year.

    Progress at the Heart Research Institute has been faster than
    expected, where three candidate compounds have been synthesised and a
    program of animal efficacy experiments has started. The experiments
    should finish before the end of this year. The aim is to prove that
    at least one of the three compounds produces enhanced iron excretion
    after oral administration to iron-overloaded mice. If this is
    established, we will select a lead compound and start a full
    preclinical program in early 2003.

    EXECUTIVE RESPONSIBILITIES

    Dr Evert Vos, previously Executive Director of Medical and Regulatory
    Affairs, has now retired from full-time responsibilities. Dr Vos
    plans to settle in North America and will continue on the Board of
    Metabolic. In addition he will continue to be available to the
    company as part-time consultant and Medical Director. In this role he
    will advise the company on medical issues which arise in the conduct
    and design of clinical trials, and assist the company with increasing
    our profile in the US.

    The Board thanks Dr Vos for his tireless efforts since the formation
    of Metabolic in steering the successful ongoing development of
    AOD9604, and looks forward to his continuing association with the
    company.

    Caroline Herd, who was appointed in November last year as Associate
    Director - Drug Development, has now taken over as Clinical Director,
    responsible for design and conduct of the clinical trial program. Dr
    Herd came to us from the Clinical Drug Development section at
    AstraZeneca in the UK, and has a PhD in pharmacology from the
    University of Adelaide.

    CASH POSITION

    As announced on Monday 20 May, the Shareholder Purchase plan raised
    $547,445 from the issue of 720,322 shares at the price of $0,76. In
    addition, $346,255 was raised from the early exercise by a
    shareholder of 1,731,276 MBPO options. The company now has cash
    reserves of approximately $12.6 million.

    For scientific background to these projects, a copy of our corporate
    presentation and other information, please visit our website
    www.metabolic.com.au or phone:

    Managing Director - Chris Belyea +61 3 9826 0949 Investor Relations -
    David Kenley +61 3 9826 0949


 
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