LEIPZIG, Germany and NES-ZIONA, Israel, Sept. 21, 2012 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE MKT: PBTH) today announced that data from the company's Phase II trial of hGH-CTP, its long acting human growth hormone, in growth hormone deficient adults will be presented at ESPE 2012, the 51st Annual Meeting of the European Society for Paediatric Endocrinology.
The previously reported data confirmed that a single weekly injection of hGH-CTP has the potential to reduce the required dosing frequency of human growth hormone from the current standard of one injection per day to a single weekly injection. In this trial, hGH-CTP demonstrated a good safety and tolerability profile. In addition, the study showed that only 50-65% of the cumulative weekly dose of conventional human growth hormone was required for the majority of the patients to remain within the normal range of IGF-1, a key biomarker of growth hormone activity. The safety profile of hGH-CTP in this trial was further enhanced by the finding that it did not cause excessive IGF-1 levels in patients, nor was any IGF-I accumulation observed.
The positive Phase II data in adults were instrumental in PROLOR's decision to proceed with a Phase II hGH-CTP trial in growth hormone deficient children that is currently enrolling patients. The pediatric Phase II trial is a randomized, open-label, dose-finding study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamic properties of hGH-CTP injected weekly in children with growth hormone deficiency. The trial is comparing the 12-month growth velocity of children receiving hGH-CTP injected once weekly with those receiving commercially available hGH injected daily.
"Growth hormone replacement therapy may enable a growth hormone deficient child to reach a normal height, but it currently involves daily dosing that may total more than 3,000 injections before the child reaches t
|SOURCE PROLOR Biotech, Inc.|
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