OPKO Health, Inc. (NYSE: OPK), announced that it will present new clinical data on its long-acting human growth hormone product (hGH-CTP) at the ICE/Endo 2014, the joint meeting of The Endocrine Society and The International Congress of Endocrinology in Chicago on June 21 st-24 th.
OPKO Biologics (formerly PROLOR Biotech) scientists will present pharmacokinetic and pharmacodynamic data from the company's advanced phase 2 trial of hGH-CTP in growth hormone deficient pediatric subjects. The data to be presented include results from the company’s phase 2 trial, which is a one year dose finding study administering hGH-CTP to growth hormone deficient children once a week using daily hGH as a comparator arm. These data affirmed that a single weekly injection of hGH-CTP has the potential to replace seven consecutive daily injections of currently marketed hGH, further validating the dosing regimen for the upcoming phase 3 trial. In addition, hGH-CTP demonstrated a very good safety and tolerability profile in this ongoing study, with no unexpected adverse events.
In addition, OPKO will hold a clinical workshop and present to endocrinologists participating in the hGH-CTP clinical studies, top line six month efficacy data from the phase 2 trial.
About Endocrine SocietyThe Endocrine Society is the world's oldest, largest, and most active organization devoted to research on hormones and the clinical practice of endocrinology. The Society works to foster a greater understanding of endocrinology amongst the general public and practitioners of complementary medical disciplines and to promote the interests of all endocrinologists at the national scientific research and health policy levels of government. For more information, visit https://www.endocrine.org/endo-2014. About hGH-CTP In June 2013, OPKO initiated a pivotal phase 3 clinical trial in adults of its proprietary long-acting version of hGH-CTP. hGH-CTP has been awarded orphan drug designation in the U.S. and Europe for both adults and children with growth hormone deficiency.