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Unigene Announces Positive Top-Line Results of Phase 2 Oral PTH Study for the Treatment of Osteoporosis in Postmenopausal Women
Date:11/9/2011

statistically significant increase in BMD compared to baseline, consistent with previously reported data.  The placebo arm showed a non-significant decline in BMD.  Safety, tolerability, pharmacokinetics (PK) and biochemical markers of bone formation and resorption were also evaluated in the study.  Positive trends in bone formation at week 24 were seen in both the oral PTH and Forsteo® arms.  Importantly, the 5mg dose of oral PTH demonstrated consistency of exposure at weeks 1 and 24 with the appropriate pulsatile PK profile.  There were no drug-related serious adverse events and no occurrences of hypercalcemia which is a common side effect of PTH therapies.  The most common adverse event in the oral PTH arm was abdominal pain.

Nozer Mehta, Ph.D., Vice President, Research and Development, commented, "Unigene's oral delivery technology achieved therapeutically effective blood levels of the experimental PTH analog and also showed acceptable variability to achieve the primary endpoint of the study.  Compared to calcitonin, PTH is a peptide requiring greater consistency and specific drug delivery criteria to accomplish the appropriate pulsatile PK profile in order to be therapeutically effective to increase BMD. This positive Phase 2 clinical study demonstrates that our oral drug delivery platform was able to meet this rigorous pharmacological objective."

Phase 2 Study Design

The Phase 2 study of oral PTH for the treatment of osteoporosis in postmenopausal women was a multicenter, double blind with respect to placebo, randomized, repeat dose placebo controlled study that included an open label comparator arm of the Forsteo® injectable formulation, and a total of 93 postmenopausal osteoporotic women were enrolled. The primary endpoint was an increase in BMD at the lumbar spine in subjects at 24 weeks following once daily treatment with 5mg orally delivered PTH analog compared to baseline. Seconda
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SOURCE Unigene Laboratories, Inc.
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