pSivida Corp: BrachySil™ Phase IIb Pancreatic Cancer Trials Commence
News Jul 08, 2008
pSivida Corp. has 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.
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.”