| Nighttime Dosing May Increase Therapeutic Benefit of Calcitonin
BOONTON, N.J.--(BUSINESS WIRE)--
Unigene Laboratories, Inc. (OTCBB: UGNE http://www.unigene.com)
has completed a clinical study which suggests that its oral tablet
formulation of calcitonin, based on its Enteripep® 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®, 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® 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 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
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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.
Source: Unigene Laboratories, Inc.
Unigene Laboratories, Inc.
Investors:
The
Investor Relations Group
Erika Moran/Dian Griesel, Ph.D.,
212-825-3210
or
Media:
Janet Vazquez,
212-825-3210
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