Prolor Biotech has released positive top-line results from a post-phase II clinical study of its long-acting CTP-modified version of human growth hormone (hGH-CTP) in growth hormone deficient adults. Data shows that two injections of hGH-CTP per month have the potential to replace 30 consecutive daily injections of currently marketed human growth hormone.
"This is encouraging news for growth hormone-deficient patients who would like to minimize their injection regimen," said Dr. Avri Havron, CEO of Prolor.
In the experimental pilot study, 12 patients were switched from daily injections of conventional hGH to a regimen of just two injections of hGH-CTP over a period of 30 days. The two injections of hGH-CTP contained either 15% or 50% of the total cumulative dose of hGH the patients would usually inject over the 30-day period. Patient IGF-1 levels, a well-accepted biomarker for assessing the activity of growth hormone therapy, were tracked in the study and served as a measure of efficacy.
“There was a clear correlation between dose and IGF-1 response, and patients receiving the 50% dose showed promising IGF-1 response to the twice-monthly hGH-CTP injection regimen,” said Havron. “We look forward to further study of the twice-monthly regimen while we also advance our ongoing clinical program for hGH-CTP administered once-weekly."