PROLOR reports positive DSMB review of long-acting human growth hormone clinical trial

Feb 14 2011

PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today reported that patient enrollment and dosing in the Phase II trial of its long-acting version of human growth hormone (hGH-CTP) are proceeding according to plan, with study completion targeted for mid-year 2011.  The study is assessing the efficacy of hGH-CTP by measuring IGF-1 levels in growth hormone deficient adults in response to administration of different doses of hGH-CTP, injected once weekly or bi-monthly.  Safety and tolerability are also being assessed.  

PROLOR also announced that a routinely scheduled review on February 9, 2011 by an independent Data and Safety Monitoring Board (DSMB), which includes world-renowned endocrinologists who are not affiliated with PROLOR, concluded that the hGH-CTP trial was safe to proceed as planned, having identified no serious safety issues associated with the investigational drug in either patients who have already completed the study or those still being dosed.

"Our long-acting version of human growth hormone has the potential to dramatically decrease the burden of daily injections currently faced by growth hormone deficient patients, and we are pleased by the continued progress in our Phase II trial," said Dr. Abraham Havron, CEO of PROLOR.  "The positive DSMB review reaffirmed our expectations that hGH-CTP should demonstrate a good safety profile.  We look forward to analyzing the Phase II efficacy data and conducting the dose estimation modeling needed for Phase III as we head towards completion of this trial in the coming months."

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 regimens.  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 who currently receive daily injections of growth hormone. The trial is being conducted at multiple sites in six countries.

Dr. Havron will discuss PROLOR's hGH-CTP program this week in a corporate presentation at the Leerink Swann Hot Topics in Therapeutics: Roundtable Conference in New York City.  The company has also been selected to participate in a panel on Emerging Platforms at the conference.  PROLOR's corporate presentation is scheduled for February 16, 2011 at 10:15 am ET and the Emerging Platforms panel will be held on the same day at 10:45 am ET.

SOURCE PROLOR Biotech, Inc.