PROLOR, www.prolor-biotech.com – the biopharma firm utilizing a proprietary CTP technology to commercialize longer-acting, biologically improved versions of existing/approved therapeutics, reported receiving FDA regulatory clearance yesterday for Phase II clinical trials of hGH-CTP, the Company’s improved and longer-acting human growth hormone.
The CTP technology allows PBTH to isolate short, naturally occurring amino acid sequences and develop them into cheaper, safer, easier to implement and more effective human growth hormones.
FDA approval follows fast on the heels of PBTH’s submission of an investigational new drug application for hGH-CTP, which contained extensive preclinical and Phase I data, in addition to proposed pre-Phase III animal study projections.
With an hGH-CTP Phase II clinical program already underway in Europe, PBTH has quickly built up a strong profile for what promises to be a superior version of human growth hormone.
CEO of PBTH, Dr. Abraham Havron, called FDA approval for Phase II trials in the US a major milestone for the Company, characterizing Phase II trials as an integral part of a sophisticated and coordinated development program designed to yield marketing authorization in US, European and global markets.
The Company will utilize European infrastructure for generating the data and, as Mr. Havron points out, FDA clearance helps to ensure synchronization with target markets, yielding a much larger commercialization window, even though trial sites may not be located in the US.
Growth hormone therapy currently requires multiple injections per week, which can be a sort of “living nightmare” for patients. The PBTH product, hGH-CTP, allows patients to live their lives more freely, requiring only two to four injections in an entire month.
The Phase I trials met all safety and tolerability endpoints, and Phase II will be constructed to further validate the safety/tolerability as a randomized, open-label, dose-finding structure which will also evaluate hGH-CTP’s pharmacokinetic and pharmacodynamic properties. That is, while the pharmacokenesis portion mathematically models drug concentration rates in bodily fluids, the pharmacodynamic portion will study the course of drug administration over time relative to the intensity of the effects.
Over 14 sites in Europe will play host to validating the promising aspects of what developers expect to be an extremely powerful revenue engine.