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Unigene Laboratories, Inc. has initiated a Phase I/II clinical study in the U.S. with its proprietary formulation of oral calcitonin for the treatment of osteoporosis
FAIRFIELD, NJ, USA | February 11, 2008 | Unigene Laboratories, Inc. (OTCBB: UGNE) has initiated a Phase I/II clinical study in the U.S. with its proprietary formulation of oral calcitonin for the treatment of osteoporosis. Twenty-four healthy postmenopausal women have been enrolled in the study, which will measure the effect of the drug on a well-established biochemical marker. The dosing is scheduled to be completed by the end of February.
The tablets being tested in the study utilize the same improved solid dosage form of Unigene's Enteripep(R) oral delivery technology used in Unigene's prior oral calcitonin study that was completed last fall. In that study, the new dosage form achieved a biological response in 100% of the study subjects.
"We are very pleased with the performance to date of these improved tablets," reported Dr. Ronald S. Levy, Executive Vice President of Unigene. "They have performed well in both animal and human studies and have demonstrated all of the properties required for a pharmaceutically-acceptable dosage form, including stability, bioavailability and dosing consistency. We have already shown that they can effectively deliver other peptides in repeated animal testing. The refinements that we have incorporated have clearly enhanced our original formulation technology and at the same time have enabled us to establish an even stronger intellectual property portfolio."
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.
SOURCE: Unigene Laboratories, Inc. |
