eHealth Bureau Prolor Biotech Inc (PBTH), the biopharma firm utilising a proprietary CTP technology to commercialise longer-acting, biologically improved versions of existing therapeutics, reported receiving FDA regulatory clearance recently 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, characterising Phase II trials as an integral part of a sophisticated and coordinated development program designed to yield marketing authorisation in US, European and global markets. The Phase I trials met all safety and tolerability endpoints, and Phase II will be constructed to further validate the safety/tolerability as a randomised, open-label, dose-finding structure which will also uate hGH-CTP’s pharmacokinetic and pharmacodynamic properties.

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