The phase IIb clinical trial commenced in October 2005 and is designed to evaluate BrachySil (32-P BioSilicon) as a potential new treatment for inoperable primary liver cancer (hepatocellular carcinoma, or HCC).
pSivida is also progressing a formal dialogue with the FDA relating to the US program for HCC and pancreatic cancers. This active discourse has provided valuable information for pSivida to advance its program planning in the US market.
The study, which was designed in collaboration with Singapore General Hospital (SGH) and approved by the Singaporean regulatory authority (Health Sciences Authority), is designed to determine the optimal dose of BrachySil in treating inoperable HCC.
The expansion of the trial means that now, in addition to the five centers currently active in Singapore, and centers in Vietnam and Malaysia, new centers are being negotiated in the Philippines and Taiwan.
In addition, the company also revealed that it expects to commence phase IIa trials of the drug candidate in pancreatic cancer in June. These trials will be conducted in hospitals in London and Singapore.
“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,” said pSivida CEO Gavin Rezos. “Our target is to generate value for our lead oncology product in all key markets, particularly the US for which the active dialogue with the FDA is a key component.”