FDA clears PROLOR Biotech's Phase II clinical trial of hGH-CTP

PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) to conduct a Phase II clinical trial in the U.S. of its longer-acting version of human growth hormone, hGH-CTP.  The regulatory clearance followed PROLOR's submission of an Investigational New Drug (IND) application for hGH-CTP that included preclinical and Phase I clinical data, as well as plans for additional animal studies that the company intends to complete prior to initiation of Phase III trials. The hGH-CTP Phase II clinical program is currently ongoing in various clinical centers in Europe.  

"The FDA regulatory clearance for conducting a Phase II trial of hGH-CTP in the U.S. is an important milestone for PROLOR," said Dr. Abraham Havron, CEO of PROLOR. "This Phase II trial, which is underway at centers in a number of European countries, is an integral part of a comprehensive and coordinated clinical development program that has been carefully designed to generate the data that we anticipate will be necessary to obtain future marketing authorization in the U.S. and Europe, as well as in other localities.  We currently do not plan to include sites in the U.S. in this Phase II trial, but the FDA clearance helps ensure that we will be fully in sync with regulatory requirements in key territories, including the U.S., allowing us to utilize the hGH-CTP European Phase II program as the basis for our anticipated submission of applications to conduct Phase III trials in both the U.S. and Europe."

PROLOR is developing hGH-CTP to provide growth hormone deficient adults and children with growth hormone therapy that requires only once-weekly or bi-monthly injections, rather than the multiple injections per week required by current hGH regimens.  The hGH-CTP Phase II clinical program follows a successful Phase I trial that suggested that hGH-CTP, in addition to meeting all safety and tolerability endpoints, could potentially be effective when injected just twice per month.

The hGH-CTP Phase II trial is a randomized, open-label, dose-finding study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic properties of hGH-CTP injected either weekly or twice-monthly in patients with growth hormone deficiency who currently receive daily injections of growth hormone.  The trial is being conducted at up to 14 sites in six countries.