Data Supporting Once-Weekly Dosing of hGH-CTP in Growth Hormone Deficient
Pediatric Population to Be Presented at the 2014 ICE/ENDO Meeting
MIAMI -- May 20, 2014
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.
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
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
Press spacebar to pause and continue. Press esc to stop.