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BioWorld Today (2271 words) |
 | Although orBec did not show a statistically significant benefit over placebo in the median time to treatment failure at study day 50, the primary endpoint, it did at study day 80, a secondary endpoint. |
| OrBec, on the other hand, acts locally by treating the gastrointestinal manifestation of the side effect, reducing the need for systemic immunosuppressives. |
| In addition to the Phase III results, the NDA will include data from a Phase II study in which orBec achieved statistical significance, showing that at day 30, iGVHD patients were able to consume at least 70 percent of their daily caloric intake by mouth, as compared to intravenous parenteral nutrition administration in the hospital. |
| BioPortfolio News : Positive new survival findings reported from phase II, III trials of orBec (642 words) |
| The analysis compares the statistically significant survival benefit demonstrated in favor of orBec in its pivotal phase III clinical trial to the survival results of the earlier successful 60 patient, randomized, double-blinded, placebo-controlled, phase II clinical trial of oral beclomethasone dipropionate for iGVHD. |
| In addition, the long term follow-up data from the phase II clinical trial are also in concordance with the long-term survival benefit seen in favor of orBec in the pivotal phase III clinical trial. |
| In spite of this, orBec was still the factor with the strongest statistical association with survival. |
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