Data Supporting Once-Weekly Dosing of hGH-CTP in Growth Hormone Deficient Pediatric Population to be Presented as a Late Brea...
September 11 2014 - 09:00AM
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.
OPKO presentations include the following:
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
Opko Health (NASDAQ:OPK)
Historical Stock Chart
From Feb 2024 to Mar 2024
Opko Health (NASDAQ:OPK)
Historical Stock Chart
From Mar 2023 to Mar 2024