OPKO to Present Long-acting Human Growth Hormone (hGH-CTP)
Sept 6, 2016 12:36:27 GMT
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Post by Deleted on Sept 6, 2016 12:36:27 GMT
OPKO to Present Long-acting Human Growth Hormone (hGH-CTP) Phase 2 Pediatric Growth Hormone Deficiency Data at the 55th Annual Meeting of the European Society for Paediatric Endocrinology
September 06, 2016 08:30 AM Eastern Daylight Time
MIAMI--(BUSINESS WIRE)--OPKO Health, Inc. (NASDAQ:OPK) will present abstracts at the 55th Annual Meeting of the European Society for Paediatric Endocrinology (ESPE) to be held in Paris, France on September 10-12, 2016.
Twenty four month phase 2 efficacy, safety, pharmacokinetic, and pharmacodynamic data from OPKO’s long acting human growth hormone, hGH-CTP, in growth hormone deficient children will be presented.
OPKO will also hold a workshop for participating endocrinologists to review final phase 3 study plans.
OPKO expects to shortly initiate a global pivotal phase 3 study in pre-pubertal growth hormone deficient children to evaluate weekly single doses of hGH-CTP versus daily injections of a presently used growth hormone product. OPKO has a world-wide collaboration agreement with Pfizer Inc. for the development and commercialization of hGH-CTP.
OPKO presentations on hGH-CTP include the following:
Oral Presentations Date
Batch-to-Batch Consistency of a Highly O-Glycosylated Long-Acting Human Growth Hormone (MOD-4023)
Session name: Growth: Clinical
Date: September 12, 2016
Session time: 09:15 - 10:45 am CEST
ESPE Abstracts (2016) 86 RFC8.3
Efficacy of Once-Weekly Administration of CTP-Modified Human Growth Hormone (MOD-4023): 24-Month Complete Database Results of a Phase 2 Study in Children with Growth Hormone Deficiency
Session name: Growth: Clinical
Date: September 12, 2016
Session time: 09:15 - 10:45 am CEST
ESPE Abstracts (2016) 86 RFC8.8
Safety and Tolerability of Once-Weekly Administration of CTP-Modified Human Growth Hormone (MOD-4023): 24-month Complete Dataset Results of a Phase 2 Study in Children with Growth Hormone Deficiency
Session name: Growth: Clinical
Date: September 12, 2016
Session time: 9:15- 10:45 am CEST
ESPE Abstracts (2016) 86 RFC8.7
Optimal Sampling of IGF-1 During Weekly Administration of a Long Acting Human Growth Hormone (MOD 4023)
Session name: Growth: Clinical
Date: September 12, 2016
Session time: 09:15 - 10:45 am CEST
ESPE Abstracts (2016) 86 RFC8.5
Additional information will be presented as e-posters:
2nd Year Pharmacokinetic and Pharmacodynamic Modeling of Long Acting Human Growth Hormone (MOD-4023) in Growth Hormone Deficient Children: ESPE Abstracts (2016) 86 P-P1-625
Immunogenicity Results of Once-Weekly Administration of CTP-Modified Human Growth Hormone (MOD-4023): A Phase 2 Study in Children with Growth Hormone Deficiency: ESPE Abstracts (2016) 86 P-P1-615
About hGH-CTP
hGH-CTP is a novel, long acting recombinant human growth hormone analog being developed by OPKO for the treatment of children with growth failure due to inadequate growth hormone secretion, and adults with growth hormone deficiency.
OPKO's proprietary technology prolongs a therapeutic protein's half life without the use of polymers, encapsulation techniques, or nanoparticles. This technology uses a natural peptide, the C-terminal peptide (CTP) of the beta chain of human chorionic gonadotropin (hCG). hGH-CTP has been granted orphan drug designation in the U.S. and Europe for both adults and children with growth hormone deficiency.
www.businesswire.com/news/home/20160906005436/en/OPKO-Present-Long-acting-Human-Growth-Hormone-hGH-CTP
September 06, 2016 08:30 AM Eastern Daylight Time
MIAMI--(BUSINESS WIRE)--OPKO Health, Inc. (NASDAQ:OPK) will present abstracts at the 55th Annual Meeting of the European Society for Paediatric Endocrinology (ESPE) to be held in Paris, France on September 10-12, 2016.
Twenty four month phase 2 efficacy, safety, pharmacokinetic, and pharmacodynamic data from OPKO’s long acting human growth hormone, hGH-CTP, in growth hormone deficient children will be presented.
OPKO will also hold a workshop for participating endocrinologists to review final phase 3 study plans.
OPKO expects to shortly initiate a global pivotal phase 3 study in pre-pubertal growth hormone deficient children to evaluate weekly single doses of hGH-CTP versus daily injections of a presently used growth hormone product. OPKO has a world-wide collaboration agreement with Pfizer Inc. for the development and commercialization of hGH-CTP.
OPKO presentations on hGH-CTP include the following:
Oral Presentations Date
Batch-to-Batch Consistency of a Highly O-Glycosylated Long-Acting Human Growth Hormone (MOD-4023)
Session name: Growth: Clinical
Date: September 12, 2016
Session time: 09:15 - 10:45 am CEST
ESPE Abstracts (2016) 86 RFC8.3
Efficacy of Once-Weekly Administration of CTP-Modified Human Growth Hormone (MOD-4023): 24-Month Complete Database Results of a Phase 2 Study in Children with Growth Hormone Deficiency
Session name: Growth: Clinical
Date: September 12, 2016
Session time: 09:15 - 10:45 am CEST
ESPE Abstracts (2016) 86 RFC8.8
Safety and Tolerability of Once-Weekly Administration of CTP-Modified Human Growth Hormone (MOD-4023): 24-month Complete Dataset Results of a Phase 2 Study in Children with Growth Hormone Deficiency
Session name: Growth: Clinical
Date: September 12, 2016
Session time: 9:15- 10:45 am CEST
ESPE Abstracts (2016) 86 RFC8.7
Optimal Sampling of IGF-1 During Weekly Administration of a Long Acting Human Growth Hormone (MOD 4023)
Session name: Growth: Clinical
Date: September 12, 2016
Session time: 09:15 - 10:45 am CEST
ESPE Abstracts (2016) 86 RFC8.5
Additional information will be presented as e-posters:
2nd Year Pharmacokinetic and Pharmacodynamic Modeling of Long Acting Human Growth Hormone (MOD-4023) in Growth Hormone Deficient Children: ESPE Abstracts (2016) 86 P-P1-625
Immunogenicity Results of Once-Weekly Administration of CTP-Modified Human Growth Hormone (MOD-4023): A Phase 2 Study in Children with Growth Hormone Deficiency: ESPE Abstracts (2016) 86 P-P1-615
About hGH-CTP
hGH-CTP is a novel, long acting recombinant human growth hormone analog being developed by OPKO for the treatment of children with growth failure due to inadequate growth hormone secretion, and adults with growth hormone deficiency.
OPKO's proprietary technology prolongs a therapeutic protein's half life without the use of polymers, encapsulation techniques, or nanoparticles. This technology uses a natural peptide, the C-terminal peptide (CTP) of the beta chain of human chorionic gonadotropin (hCG). hGH-CTP has been granted orphan drug designation in the U.S. and Europe for both adults and children with growth hormone deficiency.
www.businesswire.com/news/home/20160906005436/en/OPKO-Present-Long-acting-Human-Growth-Hormone-hGH-CTP