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Thread: AML- Fast Tracks Development of Chronic Pain Drug

  1. #1

    AML- Fast Tracks Development of Chronic Pain Drug

    AML- Fast Tracks Development of Chronic Pain Drug


    Fast Tracks Development of Chronic Pain Drug
    Leading Australian biotechnology company, Amrad Corporation Limited
    (Amrad) (ASX:AML), today announced that positive findings from its
    Phase I/II clinical trial in patients with chronic severe pain have
    led to early completion of the study, enabling the Company to advance
    AM336 to the next stage of development additional safety studies
    and a full Phase II trial to commence during 2002.
    AM336 is a synthetic version of the molecule CVID which was
    originally isolated from the venom of a fish-eating species of cone
    snail from Australia's Great Barrier Reef. Amrad has exclusive
    worldwide rights to commercialise the compound.
    The AM336 trial involved cancer patients with chronic severe pain
    from investigating centres in Sydney, Perth and Melbourne. Each
    patient received AM336 over a 12 day period to investigate the safety
    of the drug and tolerability to different dosage levels. In addition,
    under Australia's Special Access Scheme and in consultation with
    their investigating doctor, patients could elect to continue with the
    AM336 treatment beyond the 12 day study period if they felt it was
    benefiting them.
    While a full review and analysis of the data is currently being
    completed by the study investigators and our clinical development
    team, Amrad Managing Director Dr Sandra Webb said the potential of
    AM336 for major clinical benefit is now obvious.
    "From our perspective the most exciting finding relates to the fact
    that the majority of patients elected to stay on AM336 after they had
    completed the 12 day clinical trial study period. This tells us that
    AM336 can be safely administered at doses required to provide pain
    relief. These early findings are showing that AM336 has the potential
    to treat one of the most distressing symptoms of cancer, the pain,"
    Dr Webb said.
    "Our decision to finish the study earlier than planned means we can
    move toward commencement of international Phase II clinical trials.
    The potential market size for this category of drugs to treat severe
    pain is valued at around US$400 million.
    "At present severe pain treatment is dominated by the use of narcotic
    analgesics and morphine is the most common of these. However, serious
    side effects and the development of tolerance limit the use of these
    drugs. AM336 has the potential to overcome these obstacles as it
    works via a different mechanism to morphine. This really is an
    Australian breakthrough in the treatment of pain," Dr Webb said.
    Dr Webb said Amrad would now concentrate its efforts on further
    development of AM336 and will meet in March with the US Food and Drug
    Administration to discuss the details of the development pathway for
    AM336.
    "Importantly, future studies will investigate the efficacy of AM336
    in treating pain arising from a variety of diseases which cause
    chronic severe pain. These are diseases such as cancer, toxic and
    traumatic nerve damage, diabetes and viral infections," said Dr Webb.
    AM336 was discovered through a collaborative research program at the
    University of Queensland, supported by a Generic Industrial Research
    and Development (GIRD) grant, exploring the pharmaceutical potential
    of cone snail venoms.
    For further information please contact:
    Anne Hayward
    INVESTOR RELATIONS
    Telephone: 61 3 9208 4320
    Mobile: 0419 893 922

  2. #2
    BTC- Xenome progresses lead molecule into pre-clinical trials


    Xenome progresses lead molecule into pre-clinical trials
    The Directors of BioTech Capital Ltd (BTC) are pleased to announce
    that Xenome Ltd has formally progressed the development of it's lead
    molecule into pre-clinical testing. The target indication for this
    molecule is the treatment of chronic pain often experienced by
    patients suffering from cancer, AIDS and post-surgery. Current data
    indicates it is much more effective than the current standard of care
    morphine. This is an important step that moves the company one step
    closer to human clinical trials which if successful has the potential
    to significantly impact on the company's valuation. The global market
    for pain therapeutics is estimated at US$30 billion per annum with
    the market for neuropathic drugs approximately US$10 billion.
    This molecule is a completely new class of analgesic with a different
    mode of action to others derived from cone shells which are either
    in, or have completed, human clinical trials for pain treatment. The
    pre-clinical program is expected to run for 12-18 months and will be
    funded from a combination of internal resources and a Federal
    Government START grant.
    BTC has a 27.3% fully diluted equity investment and Board
    representation in Xenome.
    Additional information can be found at www.biotechcapital.com.au and
    www.xenome.com
    Full press release follows
    Contact Information
    BioTech Capital Ltd
    Harry Karelis
    DIRECTOR
    Ph: 0413 056 328
    hkarelis@challengergroup.com
    www.biotechcapital.com.au
    XENOME'S NEW POTENT PAIN DRUG FOR TRIALS
    Xenome limited, a Brisbane based biotech company, today announced the
    commencement of pre-clinical testing of a new molecule to treat
    certain types of pain, for which there is currently a lack of
    effective treatment.
    Xenome's co-founder and Head of Research, Dr Roger Drinkwater, said:
    "The molecule has proved to be effective in animals, treating
    neuropathic and inflammatory pain, with no adverse side effects.
    Xenome will now commence a series of tests to confirm efficacy and
    begin studies to define the metabolic processing of the molecule as a
    part of the preclinical testing program. These will be followed by
    more formal toxicity studies, as a prelude to testing in humans."
    The pain killing molecule is derived from the venom of a coneshell, a
    marine shellfish that uses its venom to capture prey. It represents a
    new class of molecules acting in a different way to others from this
    source.
    "Intractable chronic pain is a common, seriously debilitating
    condition often generated by nervous system disorders, diseases such
    as cancer and AIDS, and following major surgery. The new molecule
    could have broad application in the treatment of these chronic pain
    conditions," Dr Drinkwater said.
    "Currently the primary drugs used are the opiate analgesics, such as
    morphine, which are often not well tolerated by patients who require
    long-term treatment," he said.
    Xenome CEO Dr Tony Evans said the new class of molecules is a
    ground-breaking discovery that could generate important drug
    candidates, and has the potential to add significant value to the
    company. He said that preclinical testing could take between 12 and
    18 months.
    Dr Evans said the discovery of the new molecules, which was reported
    last year in the journal Nature Neuroscience, came from the work of
    the Venom Research Group at the Institute for Molecular Bioscience,
    The University of Queensland in a project led by Dr Richard Lewis and
    Professor Paul Alewood.
    "In January 2000, Xenome obtained a world wide exclusive license to
    these molecules from UniQuest, the main commercial arm of The
    University of Queensland, and is currently developing them as
    potential pain therapeutics," he said.
    The development of the new molecules is being supported by a $1.65m
    two year START grant from AusIndustry.
    For further information please contact:
    Dr Tony Evans
    CHIEF EXECUTIVE OFFICER, Xenome Limited
    Tel: 07 3720 8055 Fax: 07 3720 8388
    email: discovery@xenome.com
    or visit the Xenome website at: www.xenome.com

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