pSivida receives approval from Singapore to begin clinical trials of BrachySil

By Angela McDaniels

Seattle, Oct. 31 - pSivida Ltd. said it has received approval from Health Sciences Authority of Singapore to begin phase-2b clinical trials for BrachySil at Singapore General Hospital.

The study was designed in collaboration with the hospital and will determine the optimal dose of BrachySil in treating inoperable liver cancer, the company said.

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. pSivida said the trial will also be conducted in Malaysia and Vietnam.

These results are expected to build on the findings of a phase-2a study concluded earlier this year at the hospital, which found BrachySil to be both safe and well tolerated, the company said.

In addition, the phase-2b trial will include a clinical evaluation of pSivida's SIMPL implantation system, a fine-gauge needle, multi-injection device, through which BrachySil is injected as a liquid suspension directly into tumors under local anesthetic.

pSivida is a biotechnology company based in Perth, Australia, that develops a modified form of silicon known as BioSilicon for use in or on humans and animals.

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