Summary

One of the frontiers of current medical science is the challenge of slowing down the process of aging in an effort to prolong life and combat the debilitation caused by aging-related disorders. In this arena, human growth hormone (GH) therapy has gained both prominence and notoriety. The natural decline of growth hormone levels with age has provided a rationale for anti-aging therapies that are based on regenerating growth hormone levels in the body.

However, treatment using recombinant growth hormone has been criticized for its enhanced cancer risk, primarily through its potential to increase concentrations of its hepatic metabolite, IGF-1 (insulin-like growth factor 1) to physiologically harmful levels. IGF-1 is an antiapoptotic promoter of cellular proliferation, and is present in high concentrations during the initial stages of cancer. A clear need, therefore, exists for GH-based therapies that address this important safety concern, accompanied with detailed clinical validation.

Vitalife* is a transdermally administered analog of growth hormone releasing hormone (GHRH). GHRH is manufactured in the hypothalamus, and is the natural stimulant that promotes human growth hormone release from the pituitary. Through its mimicry of GHRH, Vitalife indirectly boosts endogenous growth hormone production, vastly improving on the efficacy and safety when compared to recombinant growth hormone therapy. In an effort to quantify the remarkable properties of Vitalife in humans, a series of clinical trials have been conducted as follows:

• A pilot study on 30 patients that studies several subjective parameters;
• A small clinical study on 53 patients that evaluates the efficacy of GH release and suppression of IGF-1 production;
• An 8-week long exhaustive, multi-centered, double blind, placebo-controlled clinical study on 117 patients that measures GH release, IGF-1 suppression and several other biochemical/hematological parameters.

These clinical studies have shed light on the ability of Vitalife to maintain sustained growth hormone release at optimum physiological concentrations, while simultaneously suppressing the levels of IGF-1. This has broken through the commonly held paradigm that high serum GH leads to increased levels of IGF-1. It should be noted that the high GH and low IGF-1 levels prevalent in youth, naturally and inversely change to low GH and high IGF-1 levels with the progress of age.

Vitalife seeks to reverse that trend, and brings us one step closer to the proverbial fountain of youth.



This document is divided in four chapters. Please click on your choice

1. Summary (You are here)
2. Introduction
3. The Clinical Evaluation of VitaLife
4. Concluding Remarks