August 05, 2015 1:18pm EDT
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK), announced that additional data from OPKO’s
hGH-CTP pediatric Phase 2 clinical trials summarized in two abstracts
entitled, “ 12 month Safety and efficacy of a weekly long-acting
growth hormone (GH, MOD-4023) compared to daily recombinant human GH
(rh)GH) therapy in pre-pubertal growth hormone deficient children; Phase
2 study – Study CP-4-004 Summary ” and “ Pharmacokinetic
(PK) and Pharmacodynamics (PD) Modeling of MOD 4023 (a long-acting human
growth hormone (hGH)) in Growth Hormone Deficient (GHD) Children ”
has been selected for oral presentation at the upcoming 54th Annual
Meeting of the European Society for Paediatric Endocrinology taking
place in Barcelona, Spain from October 1-3.
The data to be presented include results for 52 patients completing
twelve months of weekly treatment with hGH-CTP. This phase 2 study was a
one year, dose finding study administering hGH-CTP to growth hormone
deficient children once a week using Genotropin® administered daily as a
comparator arm. The twelve months data confirm comparable response of
hGH-CTP to Genotropin® injected daily as reflected by the twelve months
serum insulin-like growth factor-1 standard deviation score (IGF-1SDS)
profile, annual height velocity (HV), height velocity standard deviation
score (HV SDS) and safety profile. The data affirm the selection of an
optimal dose that would be used to demonstrate non-inferiority compared
to daily administered hGH in the upcoming phase 3 study.
OPKO oral presentations will be held at the Growth-promoting therapies
session on Saturday, October 3, 2015 at 9:55 AM and 10:05 AM.
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 the
data affirm the selection of an optimal dose, whether hGH-CTP will be
successfully developed or commercialized, expectations regarding the
product and its market potential, whether hGH-CTP will provide a
comparable response to Genotropin®, 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150805006324/en/
OPKO Health, Inc.
Steven D. Rubin or Adam Logal, 305-575-4100
or
Media
Rooney & Associates
Terry Rooney,
or
Rooney
& Associates
Marion Janic, 212-223-4017
Source: OPKO Health, Inc.
Released August 5, 2015
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