Unigene Announces Publication of Initial Results of Site-Directed Bone Growth Studies.
FAIRFIELD, N.J. -- Unigene Laboratories, Inc. (OTCBB: UGNE http://www.unigene.com) reported that the results of animal studies confirming the ability of its novel technology to rapidly form and maintain natural bone growth at targeted locations has been published. The paper, entitled "Replacement of Bone Marrow by Bone in Rat Femurs: The Bone Bioreactor," summarizes the early-stage collaborative work performed by researchers at Yale University School of Medicine and Unigene, and appears in the most recent edition of the journal Tissue Engineering.
The paper evaluated the effect of bone marrow removal from targeted sites followed by different schedules of daily injections of anabolic agents such as parathyroid hormone (PTH). The procedure created new bone tissue that appears structurally and biologically normal and demonstrated improved biomechanical properties. The combination of bone marrow removal and anabolic therapy resulted in new bone formation at a rate and to an extent that could not be achieved with anabolic agents alone. Additional studies that extend the results of this work in different animal models are ongoing. These studies should provide further evidence that the newly formed bone can be preserved over a long period of time, and will be described in future publications.
"This technology could radically change the way patients are currently treated for weakened or fractured hips, vertebrae and acute traumatic long bone fractures," stated Dr. Agn[c]s Vignery, principal investigator at Yale University and senior author of the publication. "Physicians currently treat such conditions using invasive techniques that require operating room time, utilize artificial materials, and result in imperfect outcomes. The ideal approach would be to create new bone where it is needed and at a faster rate."
"The goal of this program is to develop a simple, minimally invasive outpatient procedure in conjunction with the administration of one or more drugs that can lead to the growth of new, structurally normal bone in precisely targeted locations," said Dr. Warren Levy, President and CEO of Unigene. "If we are successful in the human studies that are planned, patients will have an inexpensive alternative to spinal fusion, vertebroplasty, total joint replacement or the insertion of metal or plastic supports that will strengthen specific bones naturally. These are major commercial opportunities and we have been told by leading experts in the medical community that there is a great need for new approaches to treat these conditions."
Tissue Engineering is an authoritative, peer-reviewed journal that explores the application of engineering to biological tissues, with the goal of developing biological approaches to treat pathological conditions.
Unigene Laboratories, Inc. is a biopharmaceutical company focusing on the oral and nasal delivery of large-market peptide drugs. Due to the size of the worldwide osteoporosis market, Unigene is targeting its initial efforts on developing calcitonin and PTH-based therapies. Fortical([R]), Unigene's nasal calcitonin product for the treatment of postmenopausal osteoporosis, received FDA approval and was launched in August 2005. Unigene has licensed the U.S. rights for Fortical([R]) to Upsher-Smith Laboratories, worldwide rights for its oral PTH technology to GlaxoSmithKline and worldwide rights for its calcitonin manufacturing technology to Novartis. Unigene's patented oral delivery technology has successfully delivered, in preclinical and/or clinical trials, various peptides including calcitonin, PTH and insulin. Unigene's patented manufacturing technology is designed to cost-effectively produce peptides in quantities sufficient to support their worldwide commercialization as oral or nasal therapeutics. For more information about Unigene, call (973) 882-0860 or visit www.unigene.com. For information about Fortical, visit www.fortical.com.
Safe Harbor statements under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements are based upon Unigene Laboratories, Inc.'s management's current expectations, estimates, beliefs, assumptions, and projections about Unigene's business and industry. 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. In addition, any statements that refer to expectations, projections, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. 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 risks and uncertainties include the risks associated with the effect of changing economic conditions, trends in the products markets, variations in Unigene's cash flow, market acceptance risks, technical development risks and other risk factors detailed in Unigene's Securities and Exchange Commission filings.
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|Date:||Feb 12, 2008|
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