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news.Unigene Laboratories, a biopharmaceutical company, has initiated a Phase I clinical study in the US with its proprietary formulation of oral parathyroid hormone for the treatment of osteoporosis.
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Approximately 24 healthy postmenopausal women have been enrolled in the study, which is designed to assess product safety and measure parathyroid hormone (PTH) blood levels at varying doses. The dosing is scheduled to be completed in October, 2008 and the data analysis is expected to be completed before year end of 2008.
The tablets being tested in the study utilize the improved Enteripep oral delivery technology. This same solid dosage form was previously used in the Phase I/II oral calcitonin clinical study conducted by Unigene earlier in 2008.
In that study, the improved version of the tablet demonstrated a more consistent biological response and reduced blood level variability when compared with earlier studies that utilized Unigene’s original oral delivery technology.
Ronald Levy, executive vice president of Unigene, said: “We are looking forward to the evaluation of the tablet’s performance with our PTH molecule. We have previously shown that it improved PTH delivery performance in animal models, so it is appropriate to now move the program into the clinic.
“We gain valuable information about our delivery technology from each study that we conduct, and we hope to leverage that knowledge into additional enhancements that can further strengthen our broad intellectual property portfolio.”