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29.08.2013 |
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Another sustained-release growth hormone in the pipeline: VRS-317
Growth hormone has a short half-life [the time it takes for half of the molecules of an administered substance to disappear from the blood vessels]. If you inject in the morning, the half-life is 14 minutes. If you inject in the evening, the half-life is 19 minutes. [J Clin Endocrinol Metab. 1993 Jul;77(1):216-20.]
Biotechnologists at Amunix, an American R&D company, decided about a decade ago that there was room for improvement, so they developed the XTEN technology. This involves attaching amino acid chains in the bacteria produced by growth hormone at the extremities of the growth hormone molecule. These amino acid chains a) reduce breakdown by enzymes, b) make the molecule soluble in water and c) prevent immune cells from attacking and destroying the chain. [Nat Biotechnol. 2009 Dec;27(12):1186-90.]
Once Amunix had refined the XTEN technology it embarked on a joint venture with the pharmaceutical company Versartis. [vertartis.com June 2, 2009] Versartis performed animal studies with VRS-317, the XTEN-version of growth hormone, and discovered that the weight increase was even bigger than that caused by regular growth hormone. [J Pharm Sci. 2012 Aug;101(8):2744-54.]
Versartis decided it was time for a registered phase-1 trial [NCT01359488]. The results of this trial were recently published in the Journal of Clinical Endocrinology and Metabolism. [J Clin Endocrinol Metab. 2013 Jun;98(6):2595-603.]
The two figures below come from the article. They show the effect of a single subcutaneous injection of different doses of VRS-317 on the levels of VRS-317 and IGF-1 in the blood over the course of one month.
The researchers discovered that ten percent of the users developed antibodies against growth hormone. They intend to investigate whether this has consequences, but believe that this will not be the case. As far as they can tell from the study they've already done VRS-317 is safe.
It is possible however that VRS-317 has other biological effects than those of regular growth hormone. The XTN technology reduces the 'fit' of the molecule in the growth hormone receptor. This may reduce the fat-reducing properties of VRS-317 in comparison with those of regular growth hormone.
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