pSivida’s BrachySil safe, effective in first human test

Oct. 11, 2004 – pSivida Ltd., an Australian biotechnology firm working to commercialize nanostructured porous silicon, said early data from a clinical trial has found that its BrachySil treatment is safe and effective at tumor regression in liver cancer patients, according to a news release.

The Phase IIA trial at Singapore General Hospital, consisting of patients with inoperable liver cancer, revealed no adverse side effects and up to 60 percent regression of tumors after three months. Unlike other approaches, BrachySil is administered directly into tumors using a fine-gauge direct needle, restricting radioactivity to the tumor itself. The trial also found that nanostructured microparticles remain in the tumor with no or insignificant detectable radioactive leakage, the release said.

The current trial will continue to encompass further reviews of all patients for regulatory approval purposes, and Phase IIB studies at several centers is expected next year. Product launch is scheduled for 2007 for liver cancer, with treatments for a wider variety of cancers expected to follow pending regulatory approvals.

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