March 03, 2015 9:31am EST
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE: OPK), today announced the presentation of two
posters at the 97th Annual Meeting of the Endocrine Society (ENDO) on
March 5 th , 2015 in San Diego, California, that will include
twelve months data from OPKO’s advanced phase 2 trial for its long
acting human growth hormone hGH-CTP in growth hormone deficient
pediatric subjects.
The data to be presented include results for 45 patients completing
twelve months of treatments. This phase 2 study is a dose finding study
administering three different doses of once weekly hGH-CTP comparing to
a fixed dose of daily Genotropin® to growth hormone deficient children.
The twelve months data confirm comparable response of hGH-CTP to daily
Genotropin®, as reflected by the similar twelve months IGF-1SDS profile,
annual height velocity (HV), HV SDS and safety profile. The data affirm
the selection of an optimal dose that will potentially demonstrate
non-inferiority compared to daily hGH in the upcoming phase 3 study in
pediatric GHD patients.
THR-148: “Top Line Results of 12 Months of Once-Weekly Administration of
CTP-Modified Human Growth Hormone (MOD-4023): Phase 2 Dose Finding Study
in Children with Growth Hormone Deficiency (GHD)”
Session details: Thursday, March 5; Time: 1:00 – 3:00 PM
THR-151: "Twelve Months Pharmacokinetics and Pharmacodynamics Profile of
Once-Weekly, CTP-Modified Human Growth Hormone (MOD-4023): Phase 2 Study
in Children with Growth Hormone Deficiency"
Visit: https://www.endocrine.org/news-room/endo-annual-meeting
About ENDO Conference
This is a unique opportunity to learn about the latest research in
fields as diverse as obesity, endocrine-disrupting chemicals, diabetes,
testosterone, infertility, menopause, thyroid conditions and much more.
Plenary sessions, symposia, free communications and poster sessions in
an interactive environment with international experts will enable
exchange of high quality clinical information and basic science and
promote international collaboration in research and clinical practice.
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
study results will demonstrate non-inferiority compared to daily hGH in
the upcoming phase 3 study in pediatric patients, 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.
OPKO Health, Inc.
Steven D. Rubin or Adam Logal, 305-575-4100
Source: OPKO Health, Inc.
Released March 3, 2015
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