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Article Excerpt
PERTH, Australia -- First Patient in Multi-Center Dose-Profiling Study Receives Treatment in Singapore General Hospital after Approval by the Health Sciences Authority
Global bio-nanotech company pSivida Limited (NASDAQ:PSDV, ASX: PSD, XETRA:PSI) today announced that Phase IIb clinical trials have commenced with BrachySil(TM) (32-P BioSilicon(TM)) as a potential new brachytherapy treatment for inoperable primary liver cancer (hepatocellular carcinoma, HCC). The first patient has successfully received treatment at Singapore General Hospital ("SGH") using a new fine-gauge needle, multi-injection device, which will enable, for the first time, larger and also multiple tumors to be treated. A total of 50 patients will be entered into this multi-center trial, which will be conducted in Singapore, Malaysia and Vietnam.
The study, which was designed in collaboration with SGH and approved by the Singaporean regulatory authority (Health Sciences Authority), will determine the optimal dose of BrachySil(TM) 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 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(TM)...
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