hGH-CTP: Human Growth Hormone

Estimated 2009 worldwide market of $3.0 billion Human Growth Hormone (hGH) is used for the long-term treatment of children and adults with growth failure due to inadequate secretion of endogenous growth hormone. The primary indications it treats in children are growth hormone deficiency, kidney disease, Prader-Willi Syndrome, and Turner's Syndrome.

In adults, the primary indications are replacement of endogenous growth hormone and the treatment of AIDS-induced weight loss. The annual market for hGH was $1.1 billion in 2005, with five companies currently marketing versions of the therapeutic protein. Patients using hGH receive daily injections 2-7 times a week. This is particularly burdensome for pediatric patients. We believe a significant market opportunity exists for a longer-lasting version of hGH that would require fewer injections.

In addition to its current use, hGH has been proven to promote a number of lifestyle benefits including non-voluntary weight loss, increased energy levels, enhanced sexual performance, improved cholesterol, younger, tighter, thicker skin, and reduced wrinkles and cellulite. We expect the hGH market to expand significantly as hGH moves beyond therapeutic treatment to include the treatment of lifestyle issues.

PROLOR conducted a Phase I study of hGH-CTP and released the results on February 2, 2010. The Phase I study enrolled 24 healthy adults who were randomized to receive one of three doses of hGH-CTP (4mg, 7mg, or 21mg) or placebo. The study results showed that safety and tolerability endpoints were met at all doses in all participants. The potential clinical efficacy of hGH-CTP was assessed by measuring the extent to which hGH-CTP induced insulin-like growth factor-1 (IGF-1) in subjects.  This biomarker is the clinically accepted primary indicator of hGH biological activity and is used by endocrinologists to optimize dosing for hGH-deficient adults.   Based on this measure, the study results suggest that the daily injections required by patients using conventional hGH could potentially be replaced with just two monthly injections of hGH-CTP.