Unigene announces results from oral PTH Phase 2 study on osteoporosis

Dec 13 2012

Unigene Laboratories, Inc. (OTCBB: UGNE), a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced that the results of its successful Phase 2 clinical trial evaluating an experimental oral parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women has been published online by Bone, the Official Journal of the International Bone and Mineral Society. The article will be published in the paper version of the journal in the coming months.

This peer reviewed manuscript, entitled, "Evaluation of the efficacy, safety and pharmacokinetic profile of oral recombinant Human Parathyroid Hormone [rhPTH(1-31)NH2] in Postmenopausal Women with Osteoporosis," provides the full efficacy and safety data from Unigene's Phase 2 clinical study of oral PTH in the treatment of osteoporosis in 97 postmenopausal women.  Kim Henriksen, MSc, PhD, Head of Musculoskeletal Diseases at Nordic Bioscience served as the lead author of the article, which was jointly prepared by authors from Nordic Bioscience, Unigene Laboratories, the Center for Clinical and Basic Research (CCBR) and GlaxoSmithKline (GSK).

Ashleigh Palmer, Unigene's Chief Executive Officer, stated, "We are extremely pleased that a peer-reviewed article detailing the positive Phase 2 results from our oral PTH program was published in such a prestigious scientific journal as Bone.  The data and analysis once again demonstrate the strength of Unigene's proprietary oral peptide drug delivery technology and the clinical potential and commercial viability of our oral PTH analog.  I would like to extend my congratulations to Dr. Henriksen for leading the publication effort and to the entire team of contributors from Nordic Bioscience, CCBR, GSK and Unigene for their tremendous work."