Oral Presentation and Poster Sessions to Highlight Positive Phase 2 Results of Oral PTH for the Treatment of Osteoporosis in Postmenopausal Women
BOONTON, N.J., Oct. 15, 2012 /PRNewswire/ -- Unigene Laboratories, Inc. (OTCBB: UGNE), a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced that its successful Phase 2 clinical trial evaluating an experimental oral parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women was the subject of an oral presentation given by Morten Karsdal, MSc, PhD, Chief Executive Officer of Nordic Bioscience, at the ASBMR 2012 Annual Meeting in Minneapolis, MN.
Dr. Karsdal's presentation, "A Phase 2 Randomized Trial of Orally Administered PTH(1-31)NH2 Tablets in Postmenopausal Women with Osteoporosis," offered an analysis of the positive efficacy data and safety profile demonstrated in Unigene's Phase 2 study of an oral tablet formulation of PTH(1-31)NH2 as a bone anabolic agent. The presentation was delivered on Sunday, October 14 as part of the ASBMR 2012 session devoted to clinical treatment of osteoporosis.
In addition to Dr. Karsdal's oral presentation, pharmacokinetic results from Unigene's Phase 2 oral PTH study were featured in a poster at the welcome reception and plenary session entitled, A Phase 2 Randomized Trial of Orally Administered PTH(1-31)NH2 Tablets in Postmenopausal Women with Osteoporosis. To access the poster and Dr. Karsdal's presentation, please visit the "Therapeutics Presentations" section under the "Unigene Therapeutics" and "Product Pipeline" tabs on the Unigene corporate website, http://www.unigene.com.
Ashleigh Palmer, Unigene's Chief Executive Officer, stated, "As reported in November 2011, the positive Phase 2 results from our oral PTH program strongly validate Unigene's proprietary oral peptide drug delivery technology and, most importantly, demonstrate that the oral delivery of PTH is possible from both an efficacy and safety standpoint. It is a great honor and opportunity to have data from this breakthrough study presented at ASBMR 2012 given the conference's high-profile convergence of industry and scientific leaders in the bone and mineral field."
Felicia Cosman, MD, osteoporosis specialist, leading clinical scientist, and medical director of the Clinical Research Center at the Helen Hayes Hospital, commented, "The ability to treat osteoporosis with an orally delivered therapeutic would be a significant advance in the treatment of the disease and a welcomed benefit to the many women around the world impacted by its crippling effects. I am very enthused and encouraged by the results of Unigene's Phase 2 study of its oral PTH analog and look forward to the continued advancement of the program."
On November 9, 2011, Unigene announced positive top-line results of its Phase 2 clinical study evaluating an experimental oral PTH analog for the treatment of osteoporosis in 93 postmenopausal women. The study achieved its primary endpoint with statistical significance and demonstrated an acceptable safety profile.
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. Secondary endpoints evaluated biochemical markers of bone formation and resorption, as well as the safety, tolerability and pharmacokinetics of the oral formulation.
About Unigene Laboratories, Inc.
Unigene Laboratories, Inc. is a leader in the design, delivery, manufacture and development of peptide-based therapeutics. The Company is building a robust portfolio of proprietary partnerships in this expanding drug class based on its Peptelligence™ platform. Peptelligence™ encompasses extensive intellectual property covering drug delivery and manufacturing technologies, unsurpassed research and development expertise, and proprietary know-how representing a genuine distinctive competence. Core Peptelligence™ assets include proprietary oral and nasal peptide drug delivery technologies, and proprietary, high-yield, scalable and reproducible E. coli-based manufacturing technologies.
Safe Harbor statements under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements, including statements relating to whether the oral delivery of PTH is possible from both an efficacy and safety standpoint; the ability to treat osteoporosis with an orally delivered therapeutic; the continued advancement of Unigene's oral PTH program; and Unigene's ability to build a robust portfolio of proprietary partnerships in peptide-based therapeutics based on its Peptelligence™ platform. These forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various risk factors. These known and unknown risk factors include, but are not limited to: the delay in obtaining or the failure to obtain regulatory approvals for our products and the products of our licensees that may generate royalty and milestone payments to us, our ability to achieve product sales and royalties, competition, our dependence on other companies to commercialize, manufacture and sell products using our technologies and our ability to enter into favorable new agreements with such companies, our ability to cut expenses and maintain efficiencies, our ability to enter into new financing arrangements, the ability of our products to gain market acceptance and increase market share, the uncertainty of results of animal and human testing, the risk of product liability and liability for human clinical trials, our dependence on patents and other proprietary rights and the risks associated with patent litigation, dependence on key management officials, the availability and cost of capital, the availability of qualified personnel, changes in, or the failure to comply with, governmental regulations, general economic and business conditions, our history of losses and ability to achieve profitability, litigation and other risk factors discussed in our Securities and Exchange Commission ("SEC") filings, including our annual report on Form 10-K and our quarterly reports on Form 10-Q. Words such as "anticipates," "expects," "intends," "plans," "predicts," "believes," "seeks," "estimates," "may," "will," "should," "would," "potential," "continue," and variations of these words (or negatives of these words) or similar expressions, are intended to identify forward-looking statements, but are not the exclusive means of identifying forward-looking statements. In addition, any statements that refer to expectations, projections, contingencies, goals, targets or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements and are not statements of historical fact. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we are under no obligation to publicly update or revise any forward-looking statements after the date of this release.
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