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pSivida to include additional sites in its phase 2b study of BrachySil for inoperable liver cancer
By Lisa Kerner
Erie, Pa., May 25 - The scope of pSivida Ltd.'s BrachySil phase 2b clinical trial for inoperable primary liver cancer (hepatocellular carcinoma, HCC) has expanded to include new centers in the Philippines and Taiwan, in addition to the centers in Singapore, Vietnam and Malaysia, according to a company news release.
The company began the trial in October 2005 and plans to seek approval for a similar program for HCC and pancreatic cancers in the United States.
pSivida said the phase 2b study is designed to determine the optimal dose of BrachySil in treating inoperable HCC. Patients will be evaluated up to 12 months following treatment. Evaluations of patient safety, target tumor responses and overall survival will serve as endpoints.
"We are delighted to announce that the liver cancer program will now be supported by a larger number of clinical centers in the key Asian region, and that clinical evaluation of the BrachySil product in pancreatic cancer remains on track," chief executive officer Gavin Rezos stated in the release.
"Our target is to generate value for our lead oncology product in all key markets, particularly the United States for which the active dialogue with the Food and Drug Administration is a key component."
In 2004, a phase 2a study of 8 patients with advanced liver cancer conducted in Singapore showed BrachySil to be safe and well tolerated. All patients experienced a decrease in the size of their tumors, some experienced complete regression and six of the patients are still alive, according to the company.
pSivida said phase 2a BrachySil trials for the treatment of pancreatic cancer are expected to begin next month in London and Singapore.
With U.S. offices in Boston, pSivida develops drug delivery products.
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