- 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
The Molecular Vision study can be accessed at http://www.molvis.org/molvis/v14/a119/
"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.|
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