Oct. 10, 2006 — Bio-nano company pSivida Ltd. of Perth, Australia, announced that the first patient has been implanted with BrachySil for the treatment of inoperable pancreatic cancer at Guys and St. Thomas’ NHS Foundation Trust Hospital in London, a major center for cancer therapy in the United Kingdom.
The treatment delivers BrachySil directly to a tumor in the pancreas via endoscopic ultrasound (used to assist in locating the delivery point). BrachySil is a novel oncology product which comprises a combination of BioSilicon and the isotope 32Phosphorus, a proven anti-cancer therapeutic.
The targeted and localized nature of the product could potentially provide oncologists with an effective and user-friendly treatment for this disease which has a high unmet clinical need. Pancreatic cancer has one of the lowest cancer survival rates with 85 percent to 90 percent of patients being diagnosed with the inoperable form of the disease.
The primary objective of the six month clinical study is to determine the safety of the image guided implantation of BrachySil. Efficacy, as determined by Computerized Tomography scanning of the tumor size and overall survival, will be secondary endpoints. The trial is being conducted in both Europe and Asia with a second clinical center at the Singapore General Hospital and the National Cancer Center Singapore. The findings will provide a platform for further multicenter efficacy and safety trials.
Pancreatic cancer is the second clinical indication for BrachySil, currently in Phase IIb clinical trials for the treatment of inoperable primary liver cancer. A Phase IIa study in inoperable primary liver cancer was completed in July 2005 and showed BrachySil to be well tolerated, according to pSivida. The company said all patients experienced a decrease in the size of their tumors, with some experiencing complete tumor regression.