pSivida, a drug delivery company, has completed enrollment of the BrachySil dose ranging clinical trial.
The dose ranging study, conducted in the UK at Guy’s and St Thomas’ NHS Foundation Trust, London and University Hospital, Birmingham is designed to assess the safety of escalating radiation doses of the BrachySil device. Patient survival and tumor response are secondary end points.
This dose ranging study follows a safety study of BrachySil in patients with inoperable pancreatic cancer. This first study had shown BrachySil in combination with standard chemotherapy was well tolerated with no clinically significant adverse events related to the device.
According to the company, the data also showed disease control in 82% of patients and an overall median survival of people in the study of 309 days. BrachySil was also found to be easily deliverable by endoscopic ultrasound.
Paul Ashton, president and CEO of pSivida, said: We are very pleased to be progressing BrachySil as a potential new treatment for pancreatic cancer, a devastating disease for patients and their families.
pSivida is a drug delivery company focused on development of miniaturized, injectable, drug delivery systems for the eye. pSivida has two products approved by the Food and Drug Administration : Retisert to treat uveitis and Vitrasert for treating AIDS-related cytomegalovirus retinitis.