brachysi phase iib pancreatic

ASX/Media RELEASE July 7, 2008
pSivida Corp: BrachySil™ Phase IIb Pancreatic
Cancer Trials Commence
Boston, MA. and Perth, Australia (July 7, 2008) – pSivida Corp. (NASDAQ: PSDV, ASX: PVA,
FF: PSI), a global drug delivery company is pleased to announce that a Phase IIb clinical trial
has commenced with BrachySil™ (P32 BioSilicon™) as a potential new brachytherapy
treatment for inoperable pancreatic cancer. The first patient has received treatment at Guy’s
and St Thomas’ NHS Foundation Trust in London. A total of six patients will be entered into this
trial at two centers in the UK (Guy’s and St Thomas’ NHS Foundation Trust, and University
Hospital, Birmingham). The study will determine the safety of escalating radiation doses of the
BrachySil™ device, with tumor response as a secondary end point.
The results of the recently completed safety study presented earlier this year at the American
Society of Clinical Oncology-GI showed that BrachySilTM, in combination with standard
chemotherapy (gemcitabine), was well tolerated with no clinically significant adverse events
related to the device. Data showed disease control in 82% of patients and an overall median
survival of 309 days. BrachySilTM 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.
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 Corp., said, “We are very pleased to be able to
progress BrachySilTM as a potential treatment for this terrible disease as we move one step
closer to approval.”
Released by:
pSivida Corp.
Brian Leedman
Vice President, Investor Relations
pSivida Limited
Tel: +61 8 9227 8327
[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: +49 251 713 2862
[email protected]
About pSivida Corp.
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 in an agreement with
[previous and future] payments up to US$78m and is in fully funded and recruited Phase III clinical trials.
pSivida has a worldwide collaborative research and license agreement with [previous and future] payments up
to US$165m with Pfizer Inc. for other ophthalmic applications of the Medidur™ technology (excluding FA).
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 68 patent families, 118 granted patents, including patents
accepted for issuance and 275 patent applications. pSivida conducts its operations from Boston in the United
States, Malvern in the United Kingdom and Perth in Australia.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: 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:
achievement of milestones and other contingent contractual payment events; 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; 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 forward-looking statements even if experience or future changes make it clear that any projected
results expressed or implied in such statements will not be realized.