pancreatic cancer study results released

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.