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Unigene Clinical Study Suggests Novel Treatment Regimen for Osteoporosis.

Nighttime Dosing May Increase Therapeutic Benefit of Calcitonin

BOONTON, N.J. -- Unigene Laboratories, Inc. (OTCBB: UGNE has completed a clinical study which suggests that its oral tablet formulation of calcitonin, based on its Enteripep[R] technology, may protect bone even more effectively if it is administered at night. The rate at which bone resorption (loss) occurs follows a diurnal rhythm, with the greatest bone loss occurring at night. The therapeutic benefit from an osteoporosis medication that reduces bone resorption would therefore be expected to be maximal with nighttime dosing. Unigene therefore conducted a small clinical study, using two different dosing regimens, which investigated the ability of nighttime calcitonin dosing to reduce the rate of bone resorption.

In one regimen, post-menopausal women were given an evening meal and then dosed with an oral calcitonin tablet or a placebo tablet five hours after the meal, approximately the time before retiring. After a one-week washout period, all women who had received oral calcitonin received the placebo and vice versa. In the second regimen, the women were dosed with the oral calcitonin two hours following the evening meal. Plasma levels of CTx-1, an established marker of bone resorption, were measured at various intervals post-dosing. As expected, women who received the placebo tablet showed very significant increases in CTx-1 levels (i.e., increasing rates of bone resorption) during the nighttime hours. The women receiving the calcitonin tablets showed CTx-1 levels that were very significantly reduced during the nighttime hours compared to the placebo.

The reductions in CTx-1 levels were similar whether the women were given the tablet two hours or five hours following the evening meal. This suggests that the timing of post-meal dosing does not reduce the effectiveness of oral calcitonin, as it does for many other pharmaceuticals.

"Nighttime dosing is likely to be a preferable treatment regimen for any anti-resorptive osteoporosis medication, and these results suggest that our oral calcitonin formulation can work quite effectively under these conditions," commented Dr. Ronald S. Levy, Executive Vice President of Unigene. "The treatment regimen prescribed for certain osteoporosis drugs would suggest that nighttime dosing is not a viable option for them, and this therefore could be a very desirable distinguishing factor for our oral calcitonin formulation."

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) 265-1100 or visit For information about Fortical, visit

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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Publication:Business Wire
Article Type:Clinical report
Date:Feb 2, 2009
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