Prolor Biotech Inc. (AMEX: PBTH; TASE: PBTH) has begun 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 to test the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamic properties of weekly injections of hGH-CTP. It will take place at 35 sites in 12 countries. The trial will compare the 12-month growth rate of children receiving weekly injections of certain doses of hGH-CTP with children receiving daily injections of commercial hGH injected daily.
The pediatric trial follows successful completion of a Phase II trial of hGH-CTP in growth hormone deficient adults, which demonstrated that the drug was safe and well tolerated, and has the potential to reduce injections of current human growth hormones from once a day to once a week. A subsequent pilot study suggested that bi-monthly dosing of hGH-CTP may also be feasible. The company plans to begin a Phase III trial of the drug on adults later this year.
Growth hormone deficiency in children occurs when the pituitary gland fails to secrete adequate amounts of growth hormone. Growth hormone replacement therapy may enable a 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.
Prolor CEO Dr. Abraham Havron said, “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."
Prolor's share price rose 2% by mid-afternoon on the TASE today to NIS 22.64, after closing at $5.97 on the American Stock Exchange yesterday, giving a market cap of $597 million.
Published by Globes [online], Israel business news - www.globes-online.com - on March 20, 2012
© Copyright of Globes Publisher Itonut (1983) Ltd. 2012