CTP-Modified hGH (MOD-4023) in Phase II Trials

**beanlicker** · 09-13-2012, 09:54 PM

PROLOR Biotech To Present Data On Its Long-Acting Human Growth Hormone At International NeuroEndocrine Meeting

Published: September 13, 2012

VIENNA, Austria and NES-ZIONA, Israel, Sept. 13, 2012 — /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE MKT: PBTH) today announced that researchers at ENEA 2012, the 15th Annual Congress of the European NeuroEndocrine Association, will present data from the company's Phase II trial of its long acting human growth hormone, hGH-CTP, in growth hormone deficient adults. The data, which were previously reported by the company, confirm that hGH-CTP has the potential to be administered once weekly to adults with growth hormone deficiency and that it appears to be safe and well tolerated. ENEA 2012 is being held September 12-15, 2012 in Vienna, Austria.
Dr. Abraham Havron, CEO of PROLOR commented, "As we move forward with the manufacturing, regulatory and clinical activities required to enter Phase III trials, we welcome the opportunity to share our positive hGH-CTP data with relevant global opinion leaders, such as those attending ENEA 2012, a biennial meeting that brings together prominent neuroendocrine researchers and clinicians to discuss important developments in the field."

The data to be presented include results from the company's Phase II trial, which administered hGH-CTP to growth hormone deficient adults for four weeks, as well as results from a 16-week treatment extension study of hGH-CTP in a similar population. These data affirmed that a single weekly injection of hGH-CTP has the potential to replace seven consecutive daily injections of currently marketed human growth hormone, and at a much lower cumulative dose, further validating the dosing regimen for the company's upcoming Phase III trial. An exploratory part of the study also demonstrated the potential for a twice-monthly injection regimen. hGH-CTP demonstrated a good safety and tolerability profile in these studies, with no unexpected adverse events.

Poster 197, Once-Weekly, CTP-Modified hGH (MOD-4023) Is Effective in Growth Hormone Deficient Adults: A Phase II Dose and Frequency Finding Study, will be presented during the September 14, 2012 poster session. For more information, visit http://www.enea2012.org.