PROLOR Biotech, a biopharm company developing long-acting human growth hormone hGH-CTP, today announced that data from the company’s phase 2 trial of hGH-CTP for application to growth hormone deficient adults will be presented at ESPE 2012, the 51st Annual Meeting of the European Society for Pediatric Endocrinology.
The previously reported phase 2 study confirms hGH-CTP as a single weekly injection vs. the current standard-CTP of one injection per day. For a child receiving growth hormone replacement therapy, the total dosing by current daily standards would mean more than 3,000 injections before the age of 18.
“hGH-CTP has the potential to dramatically reduce this number, thereby making growth hormone therapy less burdensome and more feasible,” Dr. Abraham Havron, CEO of PROLOR stated in the press release. “We welcome the opportunity to raise awareness of our progress with hGH-CTP at this meeting of pediatric endocrinology opinion leaders.”
In addition, the study showed that 50%-65% of the cumulative weekly dose of conventional human growth hormone was required for the majority of the patients to remain within the normal range of IGF-1, a key biomarker of growth hormone activity.
In this trial, hGH-CTP demonstrated a good safety and tolerability profile. The treatment did not cause excessive IGF-1 levels in patients; nor was any IGF-I accumulation observed.
Positive phase 2 data in adults tipped the scale toward the company’s decision to continue with a phase 2 hGH-CTP trial in growth hormone deficient children that is currently enrolling patients.
The pediatric phase 2 trial is designed to compare the 12-month growth velocity of children receiving hGH-CTP injected once weekly with those receiving commercially available hGH injected daily.
The company’s poster, titled Once-Weekly, CTP-Modified hGH (MOD-4023) Effectively Maintains IGF-1 Levels Within the Normal Range in Growth Hormone Deficient Adults, Supporting Initiation of Clinical Development in Children, will be presented during the September 22, 2012 poster session of ESPE 2012 in Leipzig, Germany.
For more information visit www.prolor-biotech.com or visit www.espe2012.org
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