PROLOR commences hGH-CTP Phase II trial in children with GHD

PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced initiation of a Phase II clinical trial of its long-acting CTP-modified version of human growth hormone (hGH-CTP) in children with growth hormone deficiency. 

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.

Growth hormone deficiency (GHD) in children occurs when the pituitary gland fails to secrete adequate amounts of growth hormone.  Growth hormone replacement therapy may enable a GHD child to reach a normal height, but the therapy requires daily injections and may require a total of more than 3,000 injections before the child reaches the age of 18. 

"Obtaining regulatory clearance for a clinical trial in children is a challenge for any drug developer.  We believe that our receipt of regulatory clearance for the initiation of our Phase II study in growth hormone deficient children is another indicator of the quality of our hGH-CTP program," said Dr. Abraham Havron, CEO of PROLOR.

Dr. Havron continued, "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.  We look forward to advancing our comprehensive clinical program for hGH-CTP in 2012, including this Phase II pediatric trial and an anticipated Phase III trial in growth hormone deficient adults that is targeted for later this year."

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 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.