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news.pSivida has commenced phase IIb clinical trials with its therapeutic particle, BrachySil, as a potential new treatment for inoperable primary liver cancer.
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A total of 50 patients are to be entered into the trial, which will be conducted in Singapore, Malaysia and Vietnam.
The study, which was designed in collaboration with Singapore General Hospital and approved by the Singaporean regulatory authority, will determine the optimal dose of BrachySil in treating the disease.
Patients will be evaluated up to 12 months after treatment, and the endpoints are based on evaluations of patient safety and target tumor 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.
In a previous phase IIa trial BrachySil was found to be safe and well tolerated. It was also found to reduce significantly the size of some tumors treated even on a lower dose as used in the earlier trials.
“Positive data from this trial is critical to our future plans for the commercialization of BrachySil in this indication for which we are seeking to file for registration in 2007,” Gavin Rezos, CEO of pSivida.