PSD psivida limited

pancreatic cancer study results released

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    ASX/Media RELEASE 29 January 2008
    Pancreatic Cancer Study Results Released
    Data presented at ASCO-GI
    Boston, MA and Perth, Australia (January 29, 2008) – pSivida Limited (NASDAQ:PSDV, ASX:PSD,
    Xetra:PSI) today announced the results of the Phase IIa clinical trial of BrachySilTM for the
    treatment of advanced, inoperable pancreatic cancer presented at American Society of Clinical
    Oncolgy-GI (ASCO-GI). The trial, designed as a safety study, successfully showed that
    BrachySilTM, in combination with standard chemotherapy (gemcitabine), was well tolerated with no
    clinically significant adverse events related to BrachySil. Data showed disease control in 82% of
    patients and an overall median survival of 309 days. BrachySil was found to be easily deliverable
    by endoscopic ultrasound. BrachySilTM is a novel oncology product which comprises a combination
    of BioSiliconTM, a proprietary porous silicon, and the isotope 32Phosphorus, a proven anti-cancer
    therapeutic.
    “These findings are very interesting, and although this was a small study and was not designed to
    prove efficacy, these results are encouraging,” said Dr Paul Ross, Chief Investigator in the study
    and Consultant Medical Oncologist at Guy’s and St Thomas’ NHS Foundation Trust.
    In the trial, seventeen patients were treated with BrachySil injected directly into the primary tumors
    via endoscopic ultrasound (used to assist in locating the delivery point). All patients had advanced
    inoperable pancreatic cancer and received gemcitabine in addition to BrachySil. CT assessments
    of response were performed at weeks 8, 16 and 24. The study was conducted at three major
    centers for cancer therapy: Guy's and St Thomas’ NHS Foundation Trust, UK, University Hospital
    Birmingham NHS Foundation Trust, UK and Singapore General Hospital.
    Pancreatic cancer is the fourth most frequent cause of cancer death, and at least 80% of patients
    present with inoperable locally advanced or metastatic disease. The median survival for these
    patients following diagnosis is typically less than six months with standard chemotherapy.
    Accordingly, there is significant clinical and market demand for more effective therapies.
    Dr Paul Ashton, Managing Director of pSivida Limited, said, “We are very pleased with the
    favorable results of this study of BrachySil for the treatment of advanced, inoperable pancreatic.
    Our next step for BrachySil is a dose-ranging study planned to commence this quarter.”
    -ENDSReleased
    by:
    pSivida Limited
    Brian Leedman
    Vice President, Investor Relations
    pSivida Limited
    Tel: + 61 8 9226 5099
    [email protected]
    US Public Relations
    Beverly Jedynak
    President
    Martin E. Janis & Company, Inc
    Tel: +1 (312) 943 1100 ext. 12
    [email protected]
    European Public Relations
    Eva Reuter
    Accent Marketing Limited
    Tel: +49 (254) 393 0740
    [email protected]
    -2-
    NOTES TO EDITORS:
    pSivida is a global drug delivery company committed to the biomedical sector and the development of drug
    delivery products. Retisert® is FDA approved for the treatment of uveitis. Vitrasert® is FDA approved for the
    treatment of AIDS-related CMV Retinitis. Bausch & Lomb owns the trademarks Vitrasert® and Retisert®. pSivida
    has licensed the technologies underlying both of these products to Bausch & Lomb. The technology underlying
    Medidur™ for diabetic macular edema is licensed to Alimera Sciences and is in Phase III clinical trials. pSivida has
    a worldwide collaborative research and license agreement with Pfizer Inc. for other ophthalmic applications of the
    Medidur™ technology.
    pSivida owns the rights to develop and commercialize a modified form of silicon (porosified or nano-structured
    silicon) known as BioSilicon™, which has applications in drug delivery, wound healing, orthopedics, and tissue
    engineering. The most advanced BioSilicon™ product, BrachySil™ delivers a therapeutic, P32 directly to solid
    tumors and is presently in Phase II clinical trials for the treatment of pancreatic cancer.
    pSivida’s intellectual property portfolio consists of 70 patent families, 99 granted patents, including patents
    accepted for issuance, and over 300 patent applications. pSivida conducts its operations from facilities near
    Boston in the United States, Malvern in the United Kingdom and Perth in Australia.
    pSivida is listed on NASDAQ (PSDV), the Australian Stock Exchange (PSD) and on the Frankfurt Stock Exchange
    on the XETRA system (PSI). pSivida is a founding member of the NASDAQ Health Care Index and the Merrill
    Lynch Nanotechnology Index.
    SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF
    1995: Various statements made in this release are forward-looking and involve a number of risks and
    uncertainties. All statements that address activities, events or developments that we intend, expect or believe
    may occur in the future are forward-looking statements. The following are some of the factors that could
    cause actual results to differ materially from the forward-looking statements: failure to prove efficacy for
    BrachySil; inability to raise capital; continued losses and lack of profitability; inability to develop or obtain
    regulatory approval for new products; inability to protect intellectual property or infringement of others’
    intellectual property; inability to obtain partners to develop and market products; termination of license
    agreements; competition; inability to pay any registration penalties; costs of international business
    operations; manufacturing problems; insufficient third-party reimbursement for products; failure to retain key
    personnel; product liability; inability to manage change; failure to comply with laws; failure to achieve and
    maintain effective internal control over financial reporting; amortization or impairment of intangibles; issues
    relating to Australian incorporation; potential delisting from ASX or NASDAQ; possible dilution through
    exercise of outstanding warrants and stock options or future stock issuances; potential restrictions from
    capital raises; possible influence by Pfizer; and other factors that may be described in our filings with the
    Securities and Exchange Commission. Given these uncertainties, readers are cautioned not to place undue
    reliance on such forward-looking statements. We do not undertake to publicly update or revise our forwardlooking
    statements even if experience or future changes make it clear that any projected results expressed
    or implied in such statements will not be realized.
 
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