Prolor Phase II Growth Hormone Success
PROLOR Biotech, Inc. (NYSE Amex: PBTH) announced 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. The data show that two injections of hGH-CTP per month have the potential to replace 30 consecutive daily injections of currently marketed human growth hormone.
The Phase II results reported last year showed that hGH-CTP can potentially provide a safe and effective new therapeutic option for adults with growth hormone deficiency when injected once-weekly, versus the daily injections of conventional hGH that are currently required. The results from this new pilot study indicate that hGH-CTP may be able to achieve an even better administration regimen requiring injections just twice per month.
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.
CEO Avi Havron : We believe that these results demonstrate significant potential, especially in view of the limitations of this pilot study. First, the study duration was only 30 days, thus not allowing sufficient time for patients to adjust fully to the new injection regimen. Second, patients received only 15% or 50% of their regular cumulative hGH dose. Third, the patients did not go through the dose titration procedure that physicians usually employ to optimize hGH dosing. Despite this, 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. 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..