Date: 2014-09-11
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the 53rd Annual Meeting of the European Society of Paediatric Endocrinology (ESPE ) on September 20, 2014 in Dublin, Ireland
Company: OPKO Health (USA - FL)
Product: CTP-Modified Human Growth Hormone (MOD-4023)
Action mechanism:
Disease: growth hormone deficiency
Therapeutic area: Genetic diseases - Endocrine diseases - Hormonal diseases
Country:
Trial details:
Latest
news: * On September 11, 2014, OPKO Health 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.
