CEO states " Today we announce that we are implementing an amendment to the study which involve these two key changes to the protocol summarized in figure three, namely an addition of 170 patients to the study and the elimination of an interim futility analysis on a progression free survival which is a secondary endpoint of the study. We will spend more time explaining the impact to these changes during this call, we want to make it clear that Threshold remains blinded to the data from this ongoing study. The protocol change is being implemented or the outcome of the strategic decision taking into account the current higher than anticipated enrollment rate as well as the most recently published medical findings from the Phase 3 trial conducted by the EORTC in patients with soft tissue sarcoma.
Results from our Phase 2 study suggest that TH-302 plus doxorubicin a current standard of care in front line disease is an active regiment in patients with soft tissue sarcoma. This was a single arm open label trial that enrolled 102 patients of which 91 were valuable at the maximum tolerated dose of 300 per meter square TH-302 in combination with full-dose doxorubicin. We saw improvements in all measures that we're evaluating in comparison to what we would have expected from historical benchmarks. "
Read here http://www.earningsimpact.com/
Results from our Phase 2 study suggest that TH-302 plus doxorubicin a current standard of care in front line disease is an active regiment in patients with soft tissue sarcoma. This was a single arm open label trial that enrolled 102 patients of which 91 were valuable at the maximum tolerated dose of 300 per meter square TH-302 in combination with full-dose doxorubicin. We saw improvements in all measures that we're evaluating in comparison to what we would have expected from historical benchmarks. "
Read here http://www.earningsimpact.com/
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