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news.The UK Medicines and Healthcare products Regulatory Agency has cleared GenSpera Phase II human clinical trial of G-202 in the treatment of prostate cancer patients who have failed prior hormonal therapy.
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The Phase II study is expected enroll up to 40 patients with chemotherapy-naïve, metastatic castrate-resistant prostate cancer at up to six sites in the US and the UK.
GenSpera CEO and president Craig Dionne said, "This authorization for GenSpera’s first clinical trial outside of the US is an important milestone for our company and underscores our commitment to an international clinical development program for G-202, in parallel with the US program."
GenSpera plans to begin the UK study awaiting clearance from the Multicentre Research Ethics Committee.