Searchable abstracts of presentations at key conferences in endocrinology

ea0041ep707 | Growth hormone IGF axis - basic | ECE2016

Robust viral clearance capacity of CTP-modified long-acting growth hormone (MOD-4023) downstream production process

Zakar Miri , Moschcovich Laura , Hershkovitz Oren

Background: OPKO Biologics is a clinical-stage public company developing long-acting therapeutic proteins utilizing CTP technology. The technology involves fusion of the C-terminus peptide of human chorionic gonadotropin (hCG), a highly O-glycosylated peptide, to the target protein. CTP enabled the production of a long-acting human growth hormone (hGH) (MOD-4023) that supports a single-weekly injection in growth hormone-deficient patients. MOD-4023 is manufactured as a non-vis...

ea0041ep701 | Growth hormone IGF axis - basic | ECE2016

Batch-to-batch consistency of a highly o-glycosylated long-acting human growth hormone (MOD-4023)

Moschcovich Laura , Guy Rachel , Felikman Yana , Zakar Miri , Hershkovitz Oren

Background: OPKO Biologics is a clinical-stage public company developing long-acting therapeutic proteins utilizing CTP technology. The technology involves fusion of the C-terminal peptide of human chorionic gonadotropin (hCG), which is highly O-glycosylated, to the target protein. CTP enabled the production of a long-acting human growth hormone (hGH) (MOD-4023), which supports a single weekly injection in growth hormone-deficient patients. MOD-4023 is manufactured as a non-vi...

ea0041gp139 | Paediatric Endocrinology & Development | ECE2016

2nd year efficacy results of once-weekly administration of CTP-modified human growth hormone (MOD-4023): a phase 2 study in children with growth hormone deficiency

Zelinska Nataliya , Skorodok Julia , Malievsky Oleg , Rosenfeld Ron G , Zadik Zvi , Koren Ronit , Amitzi Leanne , Hershkovitz Oren , Hart Gili , Radziuk Klaudziya

Objective: Growth hormone (GH) replacement therapy currently requires daily injections. This may cause poor compliance, inconvenience and distress for patients. CTP-modified hGH (MOD-4023) has been developed for once-weekly administration in growth hormone deficient (GHD) adults and children. The 18 and 24 month efficacy of once-weekly subcutaneous (SC) administration of MOD-4023 was evaluated in a Phase 2 study in children with GH deficiency.Design and ...

ea0041ep845 | Paediatric endocrinology | ECE2016

Safety and tolerability of once-weekly administration of CTP-modified human growth hormone (MOD-4023): phase 2 study in children with growth hormone deficiency

Zelinska Nataliya , Iotova Violeta , Skorodok Julia , Malievsky Oleg , Rosenfeld Ron G. , Zadik Zvi , Koren Ronit , Amitzi Leanne , Hershkovitz Oren , Hart Gili , Radziuk Klaudziya

Objective: Growth hormone (GH) replacement therapy currently requires daily injections. This may cause poor compliance, inconvenience and distress for patients. CTP-modified human GH (MOD-4023) has been developed for once-weekly administration in growth hormone-deficient (GHD) adults and children. In the present Phase 2 study, the safety and tolerability of once-weekly subcutaneous (SC) administration of MOD-4023 were evaluated in GHD children.Design and...