pSivida recruits Ph IIa BrachySil study

Australia's pSivida has completed the recruitment stage of a Phase IIa clinical study of BrachySil, a novel oncology product which consists of a combination of BioSilico and the isotope 32-Phosphorus, a proven anti-cancer therapeutic, for the treatment of inoperable pancreatic cancer at three leading hospitals in the UK and Singapore. All are major centers for cancer therapy.

A total of 17 patients were treated with BrachySil directly to a tumor in the pancreas via endoscopic ultrasound (used to assist in locating the delivery point), in combination with standard chemotherapy. BrachySil is designed to be a targeted and localized product and could potentially provide oncologists with an effective and user-friendly treatment for this disease which has a high unmet clinical need.

The primary objective of this 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 are secondary endpoints. Preliminary data on the balance of the patients treated will be released when a minimum eight weeks' of follow-up data have been obtained. The first analysis of all the patients is expected to be available at the end of the calendar year and results will be used to guide future studies.