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PRR annoucemnet

  1. 564 Posts. Thu 09 May 2002 1:28 PM AEST ...the market as it happens.
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    Date Time Issuer Part Headline Market Flag
    09/05/02 N/A PRR N/A Human Trial In Cancer Demonstrates Immune Responses -Tumours N/A


    Prima Biomed's (ASX: PRR) subsidiary Cancer Vac Limited today
    announced successful interim results of its Phase I human trial
    conducted in Melbourne. Patients have shown production of specific
    immune cells (T cells) that will make the body recognise the cancer
    cells as foreign and lead to attack. This was demonstrated after
    immunising cancer patients and was not associated with any toxic side

    This technology relies on boosting a patient's immune system to fight
    cancer. The novel approach involves extracting patients' blood cells,
    manipulating the immune cells and reinjecting the cells into the
    patient. This technology has been developed by scientists at the
    Austin Research Institute (ARI) over the last 10 years and has been
    the subject of intense research.

    "We are attempting to help the body's own immune system fight
    cancerous tumours by developing both a product (an immune stimulant)
    and a process (immune system manipulation) that will make the body
    recognise cancer cells as foreign and thus lead an attack to kill
    them." said Mr Marcus Clark, Chief Executive Officer of Prima Biomed.

    "These immune cells (T cells) can move through the tissues and can
    destroy solid tumours embedded in organs and tissues.

    "So far the production of tumour specific T cells has been
    technically difficult. Cancer Vac has licensed a pivotal immune
    system stimulant that has been demonstrated to preferentially produce
    such cells.

    The phase I trial in 10 cancer patients is ongoing with the analysis
    of the first 8 patients now completed. The final 2 patients are still
    undergoing treatment. The treatment was shown to produce the tumour
    specific immune response in 100% of patients analysed and who had
    completed three cycles of treatment. To date, there was no
    treatment-related toxicity, which is a critical issue in the
    development of human therapeutic agents.

    Patients who have participated in the trial will continue to be
    monitored for up to 9 months post treatment. These patients are
    monitored for sustained T cell responses, presence of measurable
    tumour markers in the patients' blood and effect of therapy on tumour
    and metastasis size and number. Results from this follow-up will
    become available towards the end of this year.

    "The results that have been recorded in this trial are the best we
    have seen in terms of immune system response. The significance of
    these results in the context of developments in cancer immunotherapy
    is very high. The preliminary results have been accepted for
    publication at the American Society of Clinical Oncology Meeting in
    the USA later this month and I am sure they will be of great interest
    to oncologists and pharmaceutical companies from around the world.

    "However, we must now show that this immune boost translates into
    clinical activity, ie the regression or stabilisation of cancer,"
    said Mr Clark. "We are now in the process of designing a further
    phase I/II study in a larger patient group to demonstrate such
    activity. It is anticipated this should begin in the 3 rd quarter of
    this year."


    It is believed that one of the reasons why cancers become established
    in the body is a result of failure by the patient's immune system to
    recognise tumour cells at an early stage. By re-exposing molecules
    produced by the cancer cells to the patient's immune system, immune
    based destruction of tumour cells can be facilitated. Certainly this
    has been the case in pre-trial animal models, particularly in mouse
    experiments conducted to date.


    The objectives of the Cancer Vac Ltd human clinical trial were two

    1. To establish if the process of cell extraction, (ex vivo)
    manipulation and re-injection of these cells could be tolerated by
    the patients; ie a toxicity study and;

    2. To determine whether the ex-vivo manipulation of the patient's
    immune cells and their exposure to Mannan-Mucin 1 (MUC 1, a tumour
    specific molecule), would elicit a specific T cell immune response
    measured by the release of the immune hormone, gamma-interferon.

    Interim analysis of the first 8 patients has been completed with no
    apparent toxicity/side effects experienced.

    Immune monitoring techniques have demonstrated the generation of a
    selective T cell immune response against the tumour molecule MUC1 in
    100% of patients analysed. The final 2 patients are still undergoing
    treatment with the trial due to be completed in July 2002.


    Mucin 1 is a glycoprotein frequently expressed in increased
    quantities by a range of cancers including breast, bowel, ovary,
    pancreas and lung. Consequently this molecule is a potential target
    antigen for immunotherapy.

    Mannan is a complex of mannose sugar molecules and is Cancer Vac's
    proprietary immune stimulant. Recombinant MUC1 is chemically linked
    to Mannan to create the "product". Dendritic Cells (cells that enable
    the body to recognise foreign proteins) carry a mannose receptor to
    which the Mannan will bind, carrying the MUC1 in to the interior of
    the antigen presenting cell and then resulting in the stimulation of
    T cells specific for MUC1.

    In the current trial, the patient's own isolated dendritic cells were
    cultured and stimulated with the Mannan-MUC1 ex-vivo and then
    re-introduced into the patient.

    Patients with MUC1 expressing tumours were selected as trial
    participants. Leukopheresis (extraction of immune stimulating cells)
    was conducted on 3 separate occasions in order to collect more than a
    billion peripheral blood mononuclear cells (PBMC). A subpopulation of
    plastic adherent PBMC were cultured with the immune hormones
    Interleukin 4 (IL-4) and Granulocyte Macrophage Colony Stimulating
    Factor (GM-CSF) for a number of days to generate the dendritic cells
    (DC). The DC were then exposed to the Mannan-MUC1 and re-injected
    intradermally and subcutaneously back into the patient.

    Ten patients have entered the study and the first eight have been
    evaluated for immune responses. All patients showed significant
    levels of gamma Interferon producing tumour MUC1 specific
    lymphocytes. A subcutaneous delayed hypersensitivity also occurred in
    all patients who had completed three cycles of treatment, which
    corroborated the gamma interferon result showing the production of
    specific immune cells.


    Patients who have participated in the trial will continue to be
    monitored for up to 9 months post treatment. These patients are
    monitored for sustained T cell responses to MUC1, presence of
    measurable tumour markers in the patient's blood and effect of
    therapy on tumour and metastasis size and number. Results from this
    follow-up will become available towards the end of this year.

    In July 2002, the design of an expanded Phase I/II study will be
    finalised. Such a study will be designed to investigate the potential
    clinical efficacy of the immune stimulant and the immunizing process.

    Marcus Clark CHIEF EXECUTIVE OFFICER 03 9287 0637
    Rudi Michelson (Monsoon Communications) 03 9620 3199

    ends - AAP

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