Drug development company Prolor Biotech Inc. (Bulletin Board: PBTH) today reported positive results from the Phase I clinical trial of its longer-acting version of human growth hormone (hGH-CTP), meeting all safety and tolerability endpoints. The study examined the drug’s potential durability (half-life), biological efficacy, and its safety and tolerability.
The trial includes 24 healthy adults who receive one of three doses of hGH-CTP (4mg, 7mg, or 21mg) or a placebo. The potential clinical efficacy of the drug was assessed by measuring the extent to which it induced insulin-like growth factor-1 (IGF-1) in the subjects. This biomarker is the clinically accepted primary indicator of hGH biological activity and is used by endocrinologists to optimize dosing for hGH-deficient adults. Based on this measure, the study results suggest that the daily injections required by patients using conventional hGH could potentially be replaced with just two monthly injections of hGH-CTP.