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Posted: July 7, 2008
pSivida Corp: BrachySil Phase IIb Pancreatic Cancer Trials Commence
(Nanowerk News) pSivida Corp. (NASDAQ:PSDV)(ASX:PVA)(FF:PSI), a global drug delivery company today announced 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 BrachySil™, 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. BrachySil™ was found to be easily deliverable by endoscopic ultrasound. BrachySil™ is a novel oncology product which comprises a combination of BioSilicon™, 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 BrachySil™ as a potential treatment for this terrible disease as we move one step closer to approval."
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.