Twelve Months Data Supporting Once-Weekly Dosing of hGH-CTP in Growth Hormone Deficient Pediatric Population to Be Presented ...
March 03 2015 - 9:31AM
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 5th, 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.
OPKO poster presentations include the following:
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"
Session details: Thursday, March 5; Time: 1:00 – 3:00 PM
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
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