BOONTON, N.J., Oct. 16, 2012 /PRNewswire/ -- Unigene Laboratories, Inc. (OTCBB: UGNE), a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced that its licensee, Tarsa Therapeutics, reported that a Phase 2 trial of its oral recombinant salmon calcitonin in the prevention of postmenopausal osteoporosis was successfully concluded and yielded statistically significant, clinically relevant improvements in bone mineral density (BMD) at the lumbar spine.
The Phase 2 trial evaluated the ability of Tarsa's oral calcitonin tablet to improve BMD at the lumbar spine after one year of daily treatment in postmenopausal women with low bone mass (osteopenia) at increased risk of fracture. Tarsa's oral calcitonin was superior to placebo in increasing BMD at the lumbar spine in this patient population, and its safety profile did not differ substantially from that of placebo. The Phase 2 study results were the subject of an oral presentation at the American Society for Bone and Mineral Research (ASBMR) 2012 Annual Meeting.
Ashleigh Palmer, Chief Executive Officer, stated, "We are delighted with the positive results from Tarsa's study of oral calcitonin in postmenopausal women with osteopenia. The safety and efficacy data in this Phase 2 study confirm the positive results that Tarsa achieved in its Phase 3 study of oral calcitonin for the treatment of postmenopausal osteoporosis."
Separately, on Friday, October 12, Tarsa announced an agreement in principle with Therapicon ® Slr to provide consulting assistance to the Italian firm in its appeal of the recent recommendation by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) to limit the use of calcitonin-containing medicines. Therapicon's request for a reexamination of the recommendation has been acknowledged by the CHMP, and a timetable for the reexamination process has been set.A poster presentation hosted by Tarsa at ASBMR 2012 discussed combined safety data from Tarsa's two recent year-long clinical trials of its oral calcitonin showing that no signal of carcinogenicity was detected.