pSivida commences phase IIb clinical trials

Perth-based bio-nanotech company pSivida (ASX:PSD, NASDAQ:PSDV, Xetra:PSI) has commenced its phase IIb clinical trials with its BrachySil technology as a potential treatment for inoperable primary liver cancer.

"This is an important next step in bringing this radical new treatment for liver cancer to market," said pSivida's investor relations manager, Brian Leedman. "For the first time we can tackle larger tumours as well as multiple tumours at the same time."

The company said the first patient with liver cancer (hepatocellular carcinoma, or HCC) had received treatment at Singapore General Hospital (SGH) using a new fine-gauge needle, multi-injection device which will enable larger and also multiple tumours to be treated. A total of 50 patients will be entered into the multi-centre trial, which will be conducted in Singapore, Malaysia and Vietnam.

"The first patient, who was treated last week, has been discharged from hospital and the treatment procedure was successful. We will be reporting on the treatment outcomes of patient trials as the results come to hand," Leedman said.

The study, which was designed in collaboration with SGH and approved by Singaporean regulators, will determine the optimal dose of BrachySil in treating inoperable HCC. Patients will be evaluated up to 12 months after treatment, and the endpoints are based on evaluations of patient safety and target tumour responses, as well as overall survival.

The study is intended to provide pivotal efficacy and safety data to support future product registration and approval of BrachySil as an effective treatment for primary liver cancer. These results are expected to build on the findings of a Phase IIa study concluded earlier this year on patients with advanced liver cancer. In this trial, which was also conducted at the SGH, BrachySil was found to be both safe and well tolerated. It was also found to reduce significantly the size of some tumours treated even on a lower dose as used in the earlier trials.

"Positive data from this trail is critical to our future plans for the commercialisation of BrachySil in this indication for which we are seeking to file for registration in 2007," said pSivida CEO Gavin Rezos in a statement.

Dr Pierce Chow, lead investigator and senior consultant, hepatobiliary and general surgery at SGH, said in a statement: "Primary liver cancer is a major malignancy and BrachySil has so far demonstrated its potential as a safe and relatively pain-free treatment. With this new trial, we expect to reaffirm the findings reported previously and bring this innovative product closer to the patients who really need it."

Last week pSivida signed a licensing agreement with Beijing Med-Pharm, which is the only western company in China licensed to sell pharmaceuticals.