PROLOR Biotech, Inc. (PBTH: Quote) said it initiated a Phase II clinical trial of its long-acting CTP-modified version of human growth hormone, or hGH-CTP, in children with growth hormone deficiency.
According to the company, the pediatric hGH-CTP Phase II trial is a randomized, open-label, dose-finding study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamic properties of hGH-CTP injected weekly in children with growth hormone deficiency.
The company said 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, which is the current standard of care. The trial is expected to take place at up to 35 sites in 12 countries.
The pediatric trial follows successful completion of a Phase II trial of hGH-CTP in growth hormone deficient adults, which demonstrated that hGH-CTP was safe and well tolerated with the potential to reduce the required dosing frequency of human growth hormone from the current standard of one injection per day to a single weekly injection. A subsequent pilot study suggested that bi-monthly dosing of hGH-CTP may also be feasible.
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by RTT Staff Writer
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