MHRA OK's BrachySil pancreatic cancer study
Australian bionanotech firm pSivida says that the UK's Medicines and healthcare Products Regulatory Agency (MHRA) has granted approval for a human trial of its targeted oncology treatment BrachySil. The product will be assessed in a six-month Phase IIa trial in patients with inoperable pancreatic cancer, which will take place at sites in the UK and Singapore.
The firm added that the program represents the first-in-man safety study of the agent in this indication and that it will seek to enroll 15 appropriate patients. The efficacy of the treatment will be measured via CT scanning of tumor size, in addition to overall survival data. The company went on to say that a Phase IIa study of the treatment as a therapy for inoperable liver cancer, which was completed in June 2005, showed that it was safe and well tolerated.
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