Unigene Successfully Completes Phase I/II Clinical Study for Oral Calcitonin
23 April 2008
Unigene Laboratories has successfully completed the Phase I/II oral calcitonin clinical study that it initiated last month. 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 twenty-two subjects who completed the study demonstrated a robust reduction in this marker. In addition, the study demonstrated a dose-dependent increase in calcitonin blood levels.
This is the second successful clinical study that the company has conducted using its improved oral calcitonin formulation. In October of last year, Unigene reported that all of the subjects in its first study achieved a biological response and that the goals for blood levels and variability were met. Those results will be reported next month at the Eighth European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis.
"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," commented Dr Ronald S Levy, Executive Vice President of Unigene. "This achievement strongly advances our calcitonin development efforts and should facilitate the partnering activities that we are pursuing in parallel.
It also confirms the importance of the delivery technology modifications that we have developed and optimized over the past year, which improve performance while simplifying the tablet manufacturing process. Finally, these improvements should provide the basis for additional intellectual property that will strengthen our patent portfolio and should improve the performance of our delivery platform for virtually any peptide that would be a suitable candidate."
