Prolor Biotech reports positive interim efficacy results from a phase II clinical trial of its long-acting CTP-modified version of human growth hormone (hGH-CTP) in growth hormone deficient adults. The interim efficacy data show that a single weekly injection of hGH-CTP, even when administered at relatively low doses, has the potential to replace seven consecutive daily injections of currently marketed human growth hormone (hGH).
The objective of the randomized open-label, multicenter phase II trial is to measure the safety and tolerability of hGH-CTP and to assess dose ranging and dose response. The trial is enrolling up to 56 growth hormone deficient adults allocated among several dosing cohorts.
The three main cohorts in the trial are receiving a single weekly dose of hGH-CTP, containing 30%, 45% or 100% of the cumulative commercial hGH dose these patients would usually inject each day over the course of seven days (referred to as the "30%, "45%" and "100%" cohorts, respectively.) The interim efficacy data reflect initial results from 34 patients, all of whom were enrolled in "low-dosing" cohorts.
In addition to the three main cohorts, Prolor researchers are also enrolling growth hormone deficient adults in an experimental fourth cohort. The patients in the experimental fourth cohort are receiving a single injection of hGH-CTP once every two weeks that contains 50% of the cumulative commercial dose of hGH that they would usually inject each day during a two-week period.