Perth-headquartered bio-nanotech company pSivida Ltd has completed the recruitment stage of the second phase of a clinical study of cancer treatment technology BrachySil in the treatment of inoperable pancreatic cancer.
Perth-headquartered bio-nanotech company pSivida Ltd has completed the recruitment stage of the second phase of a clinical study of cancer treatment technology BrachySil in the treatment of inoperable pancreatic cancer.
BrachySil is a modified form orf silicon used by the company to deliver a therapeutic directly to solid tumours.
The study took place in hospitals in the United Kingdom and Singapore.
The full text of a company announcement is pasted below
pSivida Ltd today announced the completion of the recruitment stage of the Phase IIa clinical study of BrachySil for the treatment of inoperable pancreatic cancer at three leading hospitals in the United Kingdom and Singapore. All are major centres for cancer therapy.
A total of 17 patients were treated with BrachySil directly to a tumour in the pancreas via endoscopic ultrasound (used to assist in locating the delivery point), in combination with standard chemotherapy. BrachySil is a novel oncology product which consists of a combination of BioSilicon and the isotope 32Phosphorus, a proven anti-cancer therapeutic, and is intended to be used in conjunction with standard chemotherapy for enhanced tumour response. BrachySil is designed to be a targeted and localised product and could potentially provide oncologists with an effective and user-friendly treatment for this disease which has a high unmet clinical need.
We believe the preliminary data are very encouraging. Eight weeks follow-up data available on the first 10 patients treated shows 90 per cent of these patients have had either stabilisation or reductioon in size of their primary tumour and none of these patients experienced product related signficant adverse events.
The primary objective of this study is to determine the safety of the image-guided implantation of BrachySil. Efficacy, as determined by Computerised Tornography scanning of the tumour size and overall survival are secondary endpoints. Preliminary data on the balance of the patients treated will be realised when a minimum of eight weeks 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.
Pancreatic cancer has one of the lowest cancer survival rates (five year relative survival rate of approximately 5%) with 85%-90% of patients being diagnosed with the inoperable form of the disease. There is significant clinical and market demand for effective therapies to treat this aggressive form of cancer which is the fourth leading cause of death by cancer in the United States.
"We believe that the first trial in man of BrachySIl for the treatment of inoperable pancreatic cancer represents a significant next step to bringing an effective treatment fo ran aggressive cnadcer that presently has a very low survival rate," said managing director of pSivida Ltd Dr Paul Ashton.
