July 10, 2015 9:25am EDT
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) has completed enrollment in the
single pivotal Phase 3 trial of its long acting human growth hormone
(hGH-CTP) in growth hormone deficient (GHD) adults.
The trial is designed to evaluate the safety and efficacy of hGH-CTP
with a primary endpoint of superiority compared to placebo in decreasing
fat mass in adults with GHD. The trial is a randomized, double-blind,
placebo-controlled, multi-center, global study in adults with GHD. The
study is divided into two treatment periods: a 26-week, double-blind,
placebo-controlled period, followed by a 26-week, open-label extension.
For further detail on the Phase 3 study, visit https://clinicaltrials.gov/ct2/show/NCT01909479 .
The study is expected to end toward the second half of 2016; regulatory
submission will follow study completion.
OPKO has a world-wide collaboration agreement with Pfizer, Inc. for the
development and commercialization of hGH-CTP.
About hGH-CTP
hGH-CTP is a novel, long-acting recombinant human growth hormone analog
being developed by OPKO for the treatment of children with growth
failure due to inadequate endogenous growth hormone secretion, and
adults with growth hormone deficiency (GHD) of either childhood or
adult-onset etiology. hGH-CTP is intended to reduce the burden of daily
injection therapy.
OPKO's proprietary technology enables elongation of a therapeutic
protein’s half-life without the use of polymers, encapsulation
techniques, or nanoparticles. This technology is based on a natural
peptide, the C-terminal peptide (CTP) of the beta chain of human
chorionic gonadotropin (hCG). hGH-CTP has been granted 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 timing of study
completion, whether OPKO's clinical trials for adult and pediatric
growth hormone deficiency will generate data to support marketing
approval, whether study results will demonstrate non-inferiority
compared to daily hGH, 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, litigation, and the success of
our collaboration on hGH-CTP with Pfizer, Inc. 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150710005355/en/
OPKO Health, Inc.
Steven D. Rubin or Adam Logal, 305-575-4100
Source: OPKO Health, Inc.
Released July 10, 2015
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