June 03, 2008 11:51am EDT
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- Study Published in Journal Molecular Vision -
- Results Show Good Distribution of Bevasiranib to Retina and RPE Cells after a Single Intravitreal Injection -
MIAMI, June 3 /PRNewswire-FirstCall/ -- OPKO Health, Inc. (Amex: OPK)
today announced that a study published in the peer-reviewed journal Molecular
Vision demonstrates that bevasiranib, its siRNA (small interfering RNA) agent
is distributed throughout the eye, including extensive uptake into the retina.
In two tissue distribution and pharmacokinetic studies in rabbits, results
showed that bevasiranib was present in the retina and in targeted retinal
pigment epithelium (RPE) cells following intravitreal injection. Bevasiranib
is a gene-silencing agent designed to shut down the production of vascular
endothelial growth factor (VEGF), a primary cause of the new blood vessel
growth, or neovascularization, associated with vision loss in patients with
wet age-related macular degeneration, or wet AMD. The efficacy and safety of
bevasiranib are currently being assessed in the COBALT study, an international
Phase III trial for the treatment of wet AMD.
"Importantly, these data indicate that following intravitreal injection,
bevasiranib distributes to the ocular structures relevant to the VEGF-induced
neovascularization associated with vision loss in wet AMD, and we believe this
animal data provides support for the use of bevasiranib in our ongoing pivotal
Phase III trial for the treatment of wet AMD," said Samuel Reich, Executive
Vice President of OPKO Ophthalmics. "It is noteworthy that bevasiranib was
distributed to the RPE cells, since we believe that even a fraction of the
tissue-associated bevasiranib entering the RPE cell is likely to be effective
in specifically suppressing VEGF production."
The Molecular Vision study can be accessed at
"Ocular biodistribution of bevasiranib following a single intravitreal
injection to rabbit eyes," NS Dejneka, S Wan, OS Bond, DJ Kornbrust, SJ Reich,
Molecular Vision, Volume 14, May 28, 2008
About OPKO Health, Inc.
Miami-based OPKO is a specialty healthcare company. Its lead
investigational drug, the pioneering gene silencing agent bevasiranib, has
entered a pivotal Phase III trial after successfully completing Phase II
trials for wet age-related macular degeneration and diabetic macular edema.
OPKO is developing a preclinical pipeline of novel agents for ophthalmic
diseases, and it markets innovative diagnostic imaging systems that complement
the company's therapeutic products. For more information visit the company's
website at http://www.opko.com .
This press release contains "forward-looking statements," as that term is
defined under the Private Securities Litigation Reform Act of 1995 (PSLRA),
which statements may be identified by words such as "expects," "plans,"
"projects," "will," "may," "anticipates," "believes," "should," "intends,"
"estimates," and other words of similar meaning, including statements
regarding the potential benefits and effectiveness of bevasiranib in
suppressing the production of VEGF and reducing ocular neovascularization, our
ability to establish OPKO's leadership position, our ability to aggressively
engage in R&D activities and advance clinical testing of bevasiranib and our
ability to develop a preclinical pipeline of novel agents for ophthalmic
diseases, as well as other non-historical statements about our expectations,
beliefs or intentions regarding our business, technologies and products,
financial condition, strategies or prospects. Many factors could cause our
actual activities or results to differ materially from the activities and
results anticipated in forward-looking statements. These factors include those
factors described in our filings with the Securities and Exchange Commission,
as well as risks inherent in funding, developing and obtaining regulatory
approvals of new, commercially-viable and competitive products and treatments,
including the risks that enrollment of patients for the Phase III clinical
trial for bevasiranib, may not be successful, that the Phase III clinical
trial itself may not be completed on a timely basis or at all, that any of our
compounds under development, including bevasiranib, may fail, may not achieve
the expected results or effectiveness and may not generate data that would
support the approval or marketing of products for the indications being
studied or for other indications. In addition, forward-looking statements may
also be adversely affected by general market factors, competitive product
development, product availability, federal and state regulations and
legislation, the regulatory process for new products and indications,
manufacturing issues that may arise, patent positions and litigation, among
other factors. The forward-looking statements contained in this press release
speak only as of the date the statements were made, and we do not undertake
any obligation to update forward-looking statements. We intend that all
forward-looking statements be subject to the safe-harbor provisions of the
PSLRA.
Corporate: GendeLLindheim BioCom Partners
Steven D. Rubin Barbara Lindheim
305 575-6015 212 918-4650
SOURCE OPKO Health, Inc.
Released June 3, 2008
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