May 20, 2014 10:26am EDT
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE: OPK), announced that it will present new
clinical data on its long-acting human growth hormone product (hGH-CTP)
at the ICE/Endo 2014, the joint meeting of The Endocrine Society and The
International Congress of Endocrinology in Chicago on June 21 st -24 th .
OPKO Biologics (formerly PROLOR Biotech) scientists will present
pharmacokinetic and pharmacodynamic data from the company's advanced
phase 2 trial of hGH-CTP in growth hormone deficient pediatric subjects.
The data to be presented include results from the company’s phase 2
trial, which is a one year dose finding study administering hGH-CTP to
growth hormone deficient children once a week using daily hGH as a
comparator arm. These data affirmed that a single weekly injection of
hGH-CTP has the potential to replace seven consecutive daily injections
of currently marketed hGH, further validating the dosing regimen for the
upcoming phase 3 trial. In addition, hGH-CTP demonstrated a very good
safety and tolerability profile in this ongoing study, with no
unexpected adverse events.
In addition, OPKO will hold a clinical workshop and present to
endocrinologists participating in the hGH-CTP clinical studies, top line
six month efficacy data from the phase 2 trial.
About Endocrine Society
The Endocrine Society is the world's oldest, largest, and most active
organization devoted to research on hormones and the clinical practice
of endocrinology. The Society works to foster a greater understanding of
endocrinology amongst the general public and practitioners of
complementary medical disciplines and to promote the interests of all
endocrinologists at the national scientific research and health policy
levels of government. For more information, visit https://www.endocrine.org/endo-2014 .
About hGH-CTP
In June 2013, OPKO initiated a pivotal phase 3 clinical trial in adults
of its proprietary long-acting version of hGH-CTP. hGH-CTP has been
awarded orphan drug designation in the U.S. and Europe for both adults
and children with growth hormone deficiency.
ABOUT OPKO HEALTH
OPKO is a multinational biopharmaceutical and diagnostics company that
seeks to establish industry-leading positions in large, rapidly growing
markets by leveraging its discovery, development and commercialization
expertise and novel and proprietary technologies. For more information,
visit http://www.opko.com .
SAFE HARBOR STATEMENT
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 expected benefits of hGH-CTP,
whether OPKO's clinical trials for adult and pediatric growth hormone
deficiency will generate data to support marketing approval, whether
hGH-CTP will be successfully developed or commercialized, expectations
regarding the product and its market potential, 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 the 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.
OPKO Health, Inc.
Steven D. Rubin or Adam Logal, 305-575-4100
Source: OPKO Health, Inc.
Released May 20, 2014
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