US based Unigene Laboratories has successfully completed the Phase I/II oral calcitonin clinical study.
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This study, which achieved all of its planned objectives, primarily measured the ability of Unigene’s proprietary oral delivery technology to significantly reduce the levels of an established biochemical marker that correlates with bone loss. All of the 22 subjects who completed the study, have demonstrated a robust reduction in this marker. In addition, the study demonstrated a dose-dependent increase in calcitonin blood levels.
Ronald Levy, executive vice president of Unigene, said: “The extremely significant findings of this study should enable us to select the optimal oral calcitonin dose that will be carried forward in the program. This achievement strongly advances our calcitonin development efforts and should facilitate the partnering activities that we are pursuing in parallel.”
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