| Research Performed at Yale Demonstrates Ability of Technology to Create and Maintain Natural BoneFAIRFIELD, N.J., Feb 12, 2008 (BUSINESS WIRE) -- 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. Agnes 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.
About Unigene
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.
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SOURCE: Unigene Laboratories, Inc.
Unigene Investor Contact:
The Investor Relations Group
Erika Moran/Dian Griesel, PhD
212-825-3210
Media Contact:
Lynn Granito, 212-825-3210
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