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LCT Receives Approval for DiabeCell® Clinical Trial in NZ

Discussion in 'New Zealand' started by JoeC, Sep 12, 2007.

  1. JoeC

    JoeC Approved members

    Joined:
    Aug 16, 2006
    Messages:
    56
    Living Cell Technologies Ltd
    PO Box 3014, Auburn VIC 3123
    ABN: 14 104 028 042
    COMPANY ANNOUNCEMENT
    LCT Receives Approval for DiabeCell® Clinical Trial in NZ
    12 September 2007, Auckland, New Zealand and Melbourne, Australia:
    Key Points:
    • LCT receives Regional Ethics Committee approval for diabetes clinical trial in NZ
    • LCT pig cell transplant diabetes phase I/IIa trial on track to start by end of 2007
    • LCT is the only company world-wide to obtain clinical trial approval for a pig cell transplant
    without immunosuppression under current regulatory guidelines
    • DiabeCell® product targets the type 1 diabetes market – with 24 million sufferers globally
    Living Cell Technologies Ltd (ASX:LCT, OTC:LVCLY) is pleased to announce that it has obtained
    all the regulatory and ethics approvals required by the NZ Minister of Health before proceeding
    with its type 1 diabetes phase I/IIa clinical trial in New Zealand.
    The Regional Ethics Committee has now approved LCT’s clinical trial protocols and this is the final
    of successful regulatory applications the Company has assembled to become the leading pig cell
    therapy company in clinical phase.
    The Ethics review considered key areas such as adequate patient consent, the contribution to
    knowledge and risk/benefit ratio of the trial, rare adverse events and LCT’s unique system for
    managing potential perceived risk to recipients and the community using guidelines released by
    the US Food and Drug Administration (FDA).
    Dr Paul Tan Chief Executive Officer of LCT, said: “LCT has worked closely with the regulatory
    authorities to establish the framework for conducting clinical trials with pig cells to a new
    benchmark. In doing so, LCT has built up considerable commercialisation capability and knowhow
    that are essential for taking DiabeCell® to the clinic and market.”
    Earlier this year, LCT received regulatory approvals from Medsafe and the Gene Technology
    Advisory Committee - the regulatory bodies that led the international review of the health status
    of LCT’s unique pig herd and certified its DiabeCell® manufacturing plant to Good Manufacturing
    Practice (GMP) standards for supplying medical grade pig cells for use in humans.
    In May this year, LCT became the first company to have an internationally accredited diagnostic
    facility with the suite of tests for ensuring the absence of infectious viruses and micro-organisms
    in pig tissue and a system for monitoring recipients of pig cell implants. To progress the trial,
    LCT has been working with Medsafe, Ministry of Health on the database for a register of
    transplant recipients and an archive for biological samples, as recommended by the Ethics
    Committee.
    LCT anticipates the NZ Minister of Health will accept the approvals from the regulatory bodies in
    the next few weeks, which will enable clinical trials of DiabeCell® in type I diabetes patients to
    commence in NZ in the last quarter of the 2007 calendar year.
    Further information: www.lctglobal.com
    Paul Tan - CEO
    Mob: 0402 716 984 (AUS)
    021 608 784 (NZ)
    Prof Bob Elliott - Medical
    Director
    Tel: +64 9 270 7943 (NZ)
    Mob: +64 272 924 177
    About DiabeCell® clinical trial in New Zealand
    Supported by a grant from New Zealand Trade & Enterprise, the 12 month phase I/IIa trial is to
    be conducted at a New Zealand hospital and involves the simple injection of LCT’s DiabeCell®
    product into the peritoneal cavity (abdomen) of eight insulin-dependent diabetes patients, who
    will receive these cells in a dose escalation, to establish both safety and preliminary evidence of
    efficacy.
    DiabeCell® is a natural pig pancreatic islet cell product for the treatment of insulin-dependent
    diabetes. DiabeCell® contains pig islet cells wrapped inside a protective alginate gel microcapsule.
    DiabeCell® is injected into the body without any immunosuppression and produces
    insulin to help regulate blood glucose levels appropriate to the amount of glucose detected in the
    blood stream of the diabetic recipient.
    Diabetes globally affects over 240 million people, 24 million of which have type I diabetes (2010
    projections, WHO). The direct and indirect costs of diabetes account for up to 20% of
    government healthcare expenditures. In NZ alone, over $341 million per annum is spent on
    treating diabetes, with six times more people dying from diabetes related complications than in
    the annual road toll (NZ Ministry of Health, Diabetes NZ). Human islet cell transplants are
    currently available for around US$300k per patient, but there are not enough human cadavers for
    this to be a viable treatment.
    About Living Cell Technologies: www.lctglobal.com
    Living Cell is developing live cell therapy products to treat life threatening human diseases. The
    company owns a biocertified pig herd that it uses as a source of cells for treating diabetes and
    neurological disorders. For patients with type 1 diabetes, the company transplants
    microencapsulated islet cells so that near-normal blood glucose levels may be achieved without
    the need for administration of insulin or at significantly reduced levels. The company entered
    clinical trials for its diabetes product in 2007. For the treatment of Huntington’s disease and
    other neurological disorders, the company transplants microencapsulated choroid plexus cells
    that deliver beneficial proteins and neurotrophic factors to the brain. Living Cell also offers
    medical-grade porcine-derived products for the repair and replacement of damaged tissues, as
    well as for research and other purposes.
    LCT has a US American Depositary Receipt program, enabling US residents to
    purchase LCT stock. To purchase ADRs in LCT, please contact your broker (OTC: LVCLY,
    CUSIP Number: 53838R107). More information about investing in the LCT ADR program can be
    obtained directly from Violet Pagan, Vice President Depositary Receipts at the Bank of New York,
    by email : vpagan@bankofny.com .
    LCT disclaimer
    This document contains certain forward-looking statements, relating to LCT’s business, which can be identified by the use
    of forward-looking terminology, or by express or implied discussions regarding potential filings or marketing approvals, or
    potential future sales of product candidates. Such forward-looking statements involve known and unknown risks,
    uncertainties and other factors that may cause actual results to be materially different from any future results,
    performance or achievements expressed or implied by such statements. In particular, management’s expectations
    regarding the approval and commercialization of product candidates could be affected by, among other things,
    unexpected clinical trial results; unexpected regulatory actions or delays, or government regulation generally; our ability to
    obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry,
    and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our
    products, product candidates, financial results and business prospects.
     
  2. JoeC

    JoeC Approved members

    Joined:
    Aug 16, 2006
    Messages:
    56
  3. Ellen

    Ellen Senior Member

    Joined:
    Oct 22, 2005
    Messages:
    8,240
    Thanks Joe. Please keep the information coming :cwds:.
     

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