Drug Discovery & Development - February 14, 2011
PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, reported that patient enrollment and dosing in the Phase 2 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 2 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 2 efficacy data and conducting the dose estimation modeling needed for Phase 3 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 2 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.
Date: February 14, 2011
Source: PROLOR Biotech, Inc.
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 2 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 2 efficacy data and conducting the dose estimation modeling needed for Phase 3 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 2 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.
Date: February 14, 2011
Source: PROLOR Biotech, Inc.
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