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news.PROLOR Biotech has begun Phase II trial of its CTP-modified version of human growth hormone (hGH-CTP) in children with growth hormone deficiency.
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The randomized, open-label, dose-finding study will evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamic poperties of the growth harmone.
The trial will compare the 12-month growth velocity of children receiving certain doses of hGH-CTP, injected once weekly, or commercial hGH injected daily.
Phase II trial of hGH-CTP in growth hormone deficient adults has demonstrated that it was safe and well tolerated with the potential to reduce the required dosing frequency of human growth hormone in a single weekly injection.
PROLOR CEO Abraham Havron said that the receipt of regulatory clearance for the initiation of its Phase II study in growth hormone deficient children is another indicator of the quality of hGH-CTP program.
"Our Phase II pediatric study is designed to provide information about the effectiveness and safety of a range of doses of hGH-CTP for a single weekly injection regimen in pediatric patients," Havron added.