Positive results from hGH-CTP Phase II trial in growth hormone deficient adults

Aug 4 2011

PROLOR Biotech, Inc. (NYSE Amex: PBTH) today reported positive 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 data show that a single weekly injection of hGH-CTP has the potential to replace seven consecutive daily injections of currently marketed human growth hormone (hGH).

"The findings from the Phase II trial are very promising for adults in need of growth hormone therapy and their physicians," said Dr. Avri Havron, Chief Executive Officer of PROLOR.  "The results show that hGH-CTP can potentially provide an exceptional therapy for adults with growth hormone deficiency when given once weekly, while demonstrating an excellent safety and tolerability profile across all doses and for all patients in the trial.  The Phase II trial results have enabled us to identify the most suitable dose range of hGH-CTP for our planned Phase III trial, and we look forward to its anticipated initiation in 2012."

"Based on these positive results, PROLOR is offering patients who participated in the Phase II trial the opportunity to continue treatment with single weekly injections of hGH-CTP for an additional four months," noted Shai Novik, President of PROLOR.  "Based on feedback from patients and their physicians, we expect that the majority of patients who completed the Phase II study will elect to participate in the four-month extension period, which we view as a powerful endorsement of hGH-CTP in view of the fact that those patients who elect to participate will have to undergo continued clinical monitoring requirements such as routine blood collections.  We expect that information from the voluntary extension period will provide additional data enabling us to further verify the anticipated doses and titration schedule of hGH-CTP for the planned Phase III trial."

The objectives of the randomized open-label, multicenter Phase II trial were to measure the safety and tolerability of hGH-CTP in growth hormone deficient adults and to assess dose ranging and dose response in order to identify the dose range that will be targeted in the planned Phase III trial.