September 11, 2014 9:00am EDT
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE: OPK), today announced that the abstract “Top
Line Results of Once-Weekly, CTP-Modified Human Growth Hormone
(MOD-4023): Phase 2 Dose Finding Study in Children with Growth Hormone
Deficiency (GHD)” has been selected for late breaking oral presentation
at the 53rd Annual Meeting of the European Society of Paediatric
Endocrinology (ESPE) on September 20, 2014 in Dublin, Ireland. OPKO will
present six month efficacy, safety, pharmacokinetic and pharmacodynamics
data from the company's advanced phase 2 trial for its long acting human
growth hormone hGH-CTP (MOD-4023) in growth hormone deficient pediatric
subjects.
In addition, OPKO’s posters to be presented during the conference have
been recognized for outstanding advancement by ESPE and will introduce
additional data, as well as analytical characteristics of hGH-CTP in
preparation for the planned pediatric phase 3 study.
The data to be presented include results from the company’s phase 2
trial, a one year dose finding study administering hGH-CTP to growth
hormone deficient children once a week using daily hGH as a comparator.
The data from this study supported once-weekly dosing for hGH-CTP and
also enabled the selection of an appropriate dose to demonstrate
non-inferiority compared to daily hGH in the upcoming phase 3 study.
hGH-CTP demonstrated a good safety and tolerability profile in this
ongoing study.
Oral Communication: “Top Line Results of Once-Weekly, CTP-Modified Human
Growth Hormone (MOD-4023): Phase 2 Dose Finding Study in Children with
Growth Hormone Deficiency (GHD)
Session details: FC – Late Breaking; Saturday September 20, 2014 08:45 –
09:45
Poster P1-D3-163 Six month Follow-up Pharmacokinetics and
Pharmacodynamics Profile of Once-Weekly, CTP-Modified Human Growth
Hormone (MOD-4023): Phase 2 Dose Finding Study in Children with GHD
Deficiency
Poster P1-D3-164 CHARACTERIZATION OF MOD-4023 GLYCOSYLATION, A CTP
MODIFIED LONG ACTING GROWTH HORMONE IN ADVANCED CLINICAL STAGES
About ESPE Conference
The theme of the meeting is prevention and therapeutic innovations in
pediatric endocrinology. Plenary sessions, symposia, meet-the-experts,
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. visit https:// http://www.espe2014.org/
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
(MOD-4023), whether OPKO's clinical trials for adult and pediatric
growth hormone deficiency will generate data to demonstrate
non-inferiority compared to daily hGH and support marketing approval,
whether hGH-CTP will be successfully developed or commercialized,
expectations regarding the product, its efficacy, safety and 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
Source: OPKO Health, Inc.
Released September 11, 2014
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