MBP 3.23% 3.0¢ metabolic pharmaceuticals limited

+ + data and comment + +, page-54

  1. 22,691 Posts.
    re: + + investor update - 22 september 2004 + + http://stocknessmonster.com/news-item?S=MBP&E=ASX&N=224612

    Extract:

    "• AOD9604 Phase 2B clinical trial remains on track for late
    November results announcement – detailed timetable provided
    • ACV1 on track for Phase 1 clinical trial start in early 2005
    • Preparations under way for NASDAQ listing on positive results
    • Strong cash position

    AOD9604 Obesity Drug Phase 2B Clinical Trial
    Timetable for results
    We are pleased to advise that Metabolic’s Phase 2B trial on obesity drug AOD9604 remains on schedule with key dates as follows:
    Last patient completed 12 week treatment period 17 September
    Last patient to attend one-month post-treatment follow-up visit by 20 October
    Database to be cleaned and locked followed by lifting the double-blind by mid November

    Data analysed and reported to market by 30 November

    The double-blind will be lifted once all the data from the measurements up to the one month post-treatment follow-up visit has been validated.

    The independent contract biostatistician will then analyse the data.

    Reporting format
    The Australian Stock Exchange has recently published a working draft of a Code of Best Practice for reporting by biotechnology companies.
    Metabolic will be following the draft code, a copy of which can be found on the Australian Stock Exchange website at www.asx.com.au/pdf/asx_ausbiotech.pdf.

    The sections relevant to clinical trials reporting starts on page 6.

    ACV1 analgesic
    In 2003 the Company announced the in-licensing of ACV1 for the treatment of neuropathic (nerve) pain.
    Progress has been excellent since the commencement of the ACV1 clinical development program in late 2003.

    A preclinical animal toxicology package sufficient to support Phase 1 and early Phase 2 human clinical trials is well advanced and is scheduled to be completed by January 2005.

    The results of up to two weeks of repeat dosing in
    preliminary toxicity tests have been very favourable.
    Other animal efficacy work contracted by Metabolic has also extended our knowledge of the range of activities of the compound, with encouraging pain relief obtained in several nerve injury models.

    Dosing in Phase 1 human safety trials by subcutaneous injection is scheduled to begin in Q1 2005.

    Planning for a NASDAQ listing
    We believe that offering increased access to US investors will help Metabolic gain maximum value from positive results and place the Company in a strong position to negotiate with international pharmaceutical companies.

    In addition to Metabolic's Australian Stock Exchange listing, steps are currently being taken to apply to the NASDAQ Stock Market and US Securities Exchange Commission to place existing Metabolic stock for trading in the US by way of a level 2 ADR (American Depository Receipts) listing.

    This will only be activated in late 2004 if the
    Company's Phase 2B results are positive.
    Upon subsequent initiation of a level 3 ADR listing, together with preparation of appropriate offer documentation, a future public capital raising will become possible in the US capital markets.

    Financial Position
    The Company currently has a strong cash position with more than $15 million in funds and expects to have approximately $11 million remaining at the time of the AOD9604 Phase 2B clinical trial outcome in late November.

    In the event of a positive result, it is likely that further capital will be sought to expedite the AOD9604 development path while partnering discussions proceed.

    Next Update
    The next full update is scheduled to be provided in December 2004 after a special announcement on clinical trial results by the end of November 2004".
 
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