December 04, 2008 9:16am EST
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (AMEX:OPK) announced today that it has completed
enrollment in the Company's Phase III clinical trial of bevasiranib for
the treatment of wet age-related macular degeneration (wet AMD). The
multi-national study has enrolled more than 330 patients and is designed
to assess the efficacy and safety of bevasiranib administered every 8 or
12 weeks in preventing vision loss due to wet AMD.
Bevasiranib is a first-in-class small interfering RNA (siRNA) drug
designed to silence the genes that produce vascular endothelial growth
factor (VEGF). VEGF is believed to be largely responsible for the vision
loss from wet AMD and bevasiranib is the first drug based on the Nobel
Prize-winning RNA interference (RNAi) concept to be in Phase III
clinical trials.
"This first-ever Phase III trial of an agent based on RNAi technology is
a milestone in the field of RNAi," said Phillip Frost, M.D., Chairman
and CEO of OPKO Health. "With the completion of enrollment, we are one
step closer to our goal of submitting a New Drug Application to
regulatory agencies worldwide."
About Wet AMD
Wet age-related macular degeneration is a leading cause of irreversible
vision loss in the developed world and its incidence is growing rapidly.
Advanced age is the main risk factor for wet AMD, and it is expected to
become an increasingly common condition as the population grows older.
Until recently, treatments for wet AMD were of limited efficacy. In the
search for more effective treatments, researchers targeted VEGF, shown
to be a key cause of the excess growth and leakiness of ocular blood
vessels that result in loss of vision in these patients. Current VEGF
antagonists, such as Lucentis (R) , slow this vision loss, but
require injections into the eye every four weeks, a particular issue for
elderly patients who often have limited mobility.
For more information about the COBALT bevasiranib clinical study, please
visit www.opko.com/clinicaltrials .
About OPKO Health, Inc.
Miami-based OPKO is a specialty healthcare company. Its lead
investigational drug, the gene silencing agent bevasiranib, is in Phase
III trials after successfully completing Phase II trials for wet
age-related macular degeneration and diabetic macular edema. OPKO is
developing a 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 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 our product development efforts,
our ability to develop a preclinical pipeline of novel agents for
ophthalmic diseases, our ability to commercialize bevasiranib and the
effectiveness of bevasiranib in preventing vision loss and silencing
genes that produce vascular endothelial growth factor, 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
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. 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.
Source: OPKO Health, Inc.
Released December 4, 2008
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