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clinical trial commences

  1. 115 Posts.

    HOMEX - Melbourne

    Important Australian research on rejuvenating the immune system which
    could significantly help HIV/AIDS patients has been seized upon by a
    team of distinguished international scientists for clinical trials.

    It is planned that up to 50 patients will undergo treatment in Europe
    using a novel method aimed at preventing fatal AIDS-related
    illnesses, which has been developed by the Melbourne-based
    biotechnology business development company Norwood Abbey together
    with its partner Monash University.

    The trial will be centred around the renowned University Hospital in
    Basel, Switzerland and involve input from the American National
    Institutes of Health (NIH).

    A leading researcher, Professor Manuel Battegay of Basel's University
    Hospital, today hailed the project as an "outstanding example of
    international cooperation".

    A major problem confronting HIV/AIDS patients is the recovery of the
    specialized white blood cells, called T cells, which are destroyed by
    the HIV infection. These immune cells are not only needed to control
    the virus but also to prevent other severe, often fatal, infections.
    The problem is that the thymus, the organ which exclusively produces
    the T cells, is most unexpectedly "turned off" early in life by the
    normal elevation of sex steroids from the onset of puberty. HIV/AIDS
    patients therefore have no means of restoring their immune defences.

    Monash and Norwood Abbey have shown in both clinical and animal
    studies, that temporary chemical blocking of sex steroid production
    via the use of an existing class of drugs - GnRH analogues - can
    regenerate the thymus, and thereby replace lost T cells and also
    prompt existing T cells to function better.

    "Rebooting" the immune system creates a source of new T cells, the
    body's main defence against disease. "It is our belief that if we can
    turn the immune systems of these patients back on, we will initially
    be able to stabilise the condition of these patients and eventually
    eradicate the virus from the patients body. The beauty of this
    treatment is that it is the patients own body and mother nature that
    do all the work" commented an excited Associate Professor Richard
    Boyd of Monash University.

    "We currently have good anti-HIV drugs that act on the virus itself
    but we urgently need agents that specifically boost the immune
    system. GnRH analogues could potentially be used in this way" says
    Professor Sharon Lewin, Director of Infectious Diseases at the Alfred
    Hospital in Melbourne.

    "If this therapy can be translated to HIV/AIDS patients it promises
    to overcome one of the most important hurdles in HIV therapy", Dr
    Battegay said. These thoughts were echoed by fellow Basel
    immunologist, Professor George Hollander. "We are delighted to be
    able to move to this globally important trial based on such excellent
    research developed in Melbourne."

    The National Institutes of Health is part of the U.S. Government's
    Department of Health. Daniel Douek, chief of the Human Immunology
    Section of the NIH Vaccine Research Centre in Washington said, "The
    NIH is gratified to be involved with pre-eminent HIV/AIDS research
    groups in Europe to help in this vital work. The work in Australia to
    potentially create a major component of the therapy for HIV treatment
    is most impressive." The Swiss-centred trial is also planned to be
    run simultaneously on HIV/AIDS patients in Australia.

    The aims of the trial include:

    * Restoring a collapsed immune system.
    * Programming or preparing the immune system to better respond to
    * Investigating its potential use in gene therapy.

    Associate Professor Richard Boyd also stated "The GnRH analogues have
    been successfully used for many years in the treatment of prostate
    and breast cancer. As this is a new use for an existing class of
    drugs, the time to validate the new indication is relatively short
    and therefore treatment has the potential to be in the clinic within
    a couple of years"

    Welcoming the trial, the chairman of Norwood Abbey, Mr Peter Hansen,
    said today that he recently met the leaders of this new international
    research team and was impressed by their enthusiastic endorsement.
    "This is a further example of how a team combining researchers, a
    university and a biotechnology business development company can move
    quickly with the likelihood of outstanding results."

    The planned HIV/AIDS study follows encouraging results from Melbourne
    based studies involving patients with prostate cancer and patients
    undergoing bone marrow transplantation.
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