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
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.
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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,"
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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
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