SBP solbec pharmaceuticals limited

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    here it is

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    PHARMACEUTICAL PROJECTS

    The first three months of this year have seen significant advances in
    the development of BEC(R) and the Lawley projects. During the quarter
    significant laboratory, animal and clinical studies have been
    completed. The Company has set up new premises and improved
    communications. We have made important progress relevant to the
    eventual commercialisation of the projects. Progress has been better
    than expected and the Board is pleased with results to date.

    BEC(R)

    Laboratory studies have continued to expand the number of cancer cell
    lines that BEC(R) is active against with a further 23 tumours tested
    in the USA bringing to over 60 tumours tested to date with BEC(R)
    exhibiting activity against all tumours tested. Results from the USA
    study have been documented in combination with clinical data from
    Australia in a dissertation which has been accepted for presentation
    at the worlds foremost cancer research conference (American
    Association of Cancer Research) in the USA in April.

    Laboratory based research has been particularly rewarding recently.
    The research group has established much simplified procedures for the
    separation and purification of individual components of BEC(R). This
    will greatly enhance the preparation (and Registration) of
    therapeutic BEC(R) formulations in the future.

    The R&D team have also managed to enhance the activity of BEC(R) by
    up to 300% over our original formulation with significant reduction
    in irritation side effects. This reformulated product is now being
    used in the animal trials and through the Special Access Scheme in
    humans.

    Animal studies are progressing and provide strong support to both our
    human and veterinary regulatory submissions for BEC(R) and continue
    to generate interesting data. Results demonstrate the safety and
    efficacy of the compound in the environments tested. Studies have
    also demonstrated total tumour regression (ie no histological
    evidence of tumour at the and of the study) in some studies with only
    mild toxicity effects. Studies have also shown that BEC(R) is
    effective in slowing tumour growth and eradication of tumour when
    treating both mesothelioma and melanoma intratumourally in induced
    mouse models.

    Solbec is focusing the clinical development of BEC(R) on the lung
    cancers, malignant pleural mesothelioma and metastatic melanoma of
    the lung. Mesothelioma is an asbestos related cancer of the lung that
    is currently incurable. The disease takes a long time to develop or
    become observable (approximately 20 to 30 years after exposure). The
    average survival period after diagnosis is less than 12 months.
    Whilst this disease is not prolific in society it, with the other
    asbestos related cancers, will result in approximately 65,000 deaths
    in Australia between now and 2020 when the disease is forecast to
    peak. Developing a treatment for mesothelioma also opens up the
    Orphan Drug Program for the company. This is a program that results
    in a much more expeditious route to market with a reduced program of
    clinical testing and a fast track through the regulatory process. Eg
    the Novartis product Gleevac took 9 weeks to pass through the US FDA
    where the average approval time is 29 months.

    Discussions are continuing with prestigious groups to facilitate the
    initiation of human clinical trials of BEC(R) here within Australia.
    The trials will be centered on our target indications of malignant
    pleural mesothelioma and metastatic melanoma of the lung.

    Preliminary submissions have been made to the US Food and Drug
    Administration and a meeting with the US regulators is scheduled for
    next quarter. The Company is seeking approval from the FDA of our
    preclinical project outline for the development of BEC(R) in the US.
    This approval will allow the commencement of US based human trials
    generating data to support our US regulatory submission.

    In the meantime BEC(R) continues to be available via the TGA's
    Special Access Scheme here in Australia with in excess of 30 patients
    treated to date. The range of neoplastic conditions that BEC(R) has
    treated continues to expand with favourable results. The data
    generated through this scheme will support our other studies and
    accelerate human clinical trials.

    We have continued to strengthen our intellectual property portfolio
    with one patent being accepted in Japan and another now in its
    international prosecution phase receiving a favorable international
    preliminary examination report. (since the end of the reporting
    period a third patent has been lodged in Australia and the USA) We
    will continue to develop further IP.

    The diagnostic potential of BEC(R) has been further investigated and
    is a very exciting area of research. From initial studies it appears
    that we will be able to diagnose skin cancers, primary tumours and
    metastatic disease using three different but simple diagnostic tests.
    We are looking for a commercial partner to work with us in the
    development of these tests.

    OTHER PRODUCTS

    Preliminary therapeutic activity studies on DPXC-01 have shown that
    it is active against both Herpes Simplex types I and II (cold sores
    and genital herpes) with eradication of symptoms within 48 hours.

    DPX-01 is active against various cancers showing activity against 6
    of the 12 tested so far.

    Limited work has been carried out on these projects during the period
    whist we focus on BEC(R) and the Lawley Steroids Project.

    STEROID PRODUCTS

    The Lawley Joint Venture continues to progress well. We have received
    a preliminary assessment of the regulatory file submitted to the
    Australian TGA, for Andro-feme (testosterone for women). As is usual,
    for a preliminary assessment the TGA have requested further
    documentation. This is currently being prepared and should lead to a
    favourable outcome. We still await a response from the New Zealand
    regulatory authority for the Andro-feme file submitted. Successful
    outcomes of these submissions will enable sales and marketing
    activities to rapidly increase the revenue stream generated by the
    Lawley products.

    Regulatory submissions for other Lawley products are in preparation
    and are expected to be submitted to the regulatory authorities by the
    end of the 2002.

    GENERAL

    In December the Solbec Pharmaceutical Division moved into new
    premises and has built a new laboratory to expedite the developmental
    process. We have employed specialist chemists to work on the
    projects. The manufacturing facility is in the design phase and once
    the work up of the final extraction process is completed, building of
    a commercial pilot scale facility to FDA standards will commence.

    The horticultural facility is in full swing with over 2000 plants now
    growing and about 75% of these are now fully mature and fruiting
    prolifically. Further work is being carried out to confirm the best
    genotype.

    www.solbec.com.au our new website has been well received with the
    website having over 2000 visitors so far. The website also allows
    interested people to subscribe to Solbecs' news service so that they
    will be automatically emailed whenever a news article, report or
    announcement is made regarding Solbec.

    MORE TO FOLLOW


 
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