Study confirms safety of BrachySil for treatment of inoperable pancreatic cancer

Jan 30 2008

The results of a Phase IIa clinical trial of BrachySil for the treatment of advanced, inoperable pancreatic cancer were presented at American Society of Clinical Oncolgy-GI (ASCO-GI) this weekend in a poster presented by Dr. Paul Ross, Chief Investigator in the study and Consultant Medical Oncologist at Guy's and St. Thomas' NHS Foundation Trust.

The trial, designed as a safety study, successfully showed that BrachySilTM, in combination with standard chemotherapy (gemcitabine), was well tolerated with no clinically significant adverse events related to BrachySil. 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. BrachySilTM is a novel oncology product which comprises a combination of BioSiliconTM, a proprietary porous silicon, and the isotope 32Phosphorus, a proven anti-cancer therapeutic.

“These findings are very interesting, and although this was a small study and was not designed to prove efficacy, these results are encouraging,” said Dr. Ross.

In the trial, seventeen patients were treated with BrachySil injected directly into the primary tumors via endoscopic ultrasound (used to assist in locating the delivery point). All patients had advanced inoperable pancreatic cancer and received gemcitabine in addition to BrachySil. CT assessments of response were performed at weeks 8, 16 and 24. The study was conducted at three major centers for cancer therapy: Guy's and St Thomas' NHS Foundation Trust, UK, University Hospital Birmingham NHS Foundation Trust, UK and Singapore General Hospital.

Pancreatic cancer is the fourth most frequent cause of cancer death, and at least 80% of patients present with inoperable locally advanced or metastatic disease. The median survival for these patients following diagnosis is typically less than six months with standard chemotherapy. Accordingly, there is significant clinical and market demand for more effective therapies.

Dr Paul Ashton, Managing Director of pSivida Limited, the company that developed BrachySil and sponsored the trial, said, “We are very pleased with the favorable results of this study of BrachySil for the treatment of advanced, inoperable pancreatic. Our next step for BrachySil is a dose-ranging study planned to commence this quarter.”

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