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pSivida drug holds promise for liver cancer patients

A phase II trial conducted by the Australia-based nanotechnology company pSivida in alliance with the Singapore General Hospital has successfully proved the safety of BrachySil as a potential new brachytherapy treatment for inoperable primary liver cancer.

The company succeeded in achieving the primary endpoint of the trial to establish the safety of the drug. BrachySil (32-P BioSilicon) was found to be both safe and well tolerated; no significant treatment related side-effects were noted.

The trial was conducted on eight patients with advanced liver cancer who were evaluated after three and six months following treatment. The results show that participants treated with BrachySil experienced significantly reduced tumor size as determined by scanning technology.

The company is currently preparing to embark on a multi-center phase II dose-profiling study of BrachySilin, which is scheduled to begin later in 2005. This study is expected to provide data to support the registration of BrachySilas an approved treatment for liver cancer.

Dr Pierce Chow, senior consultant at Singapore General Hospital (SGH), said: “From the perspective of patients suffering with advanced cancer of this kind, BrachySil promises to offer the possibility of an effective, safe and relatively pain-free treatment, which can potentially improve both the duration and quality of life. We, at the SGH, are very encouraged by the promising data seen to date with BrachySil and are optimistic that subsequent clinical trials will continue to show positive results in this and other serious cancer indications.”

BrachySil is a micron-sized nanostructured silicon particle in which radioactive 32-phosphorus (32-P) is immobilized. It is administered as a liquid suspension through a fine-gauge needle directly into tumors. The procedure takes place under local anesthetic and without the need for shielded rooms or robotic injectors, and patients can be discharged the next day.

Shares in pSivida rose by 8% following the release of the trial data