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– An extended-release human growth hormone formulation proved safe and effective in both children and adults, offering the prospect of a less-rigorous dosing schedule and potentially better patient compliance with treatment.
They showed a mean maximum stimulated growth hormone level of 5.4 ng/m L.
Although they were a mean of 7.8 years chronologically at the study’s outset, their mean bone age was 6.4 years.
The active portion is recombinant human growth hormone, which is bound to long chains of hydrophilic amino acids. Of the two phase II studies of the molecule, in 36 adults with adult-onset growth hormone deficiency.
The company also has made these presentations available online.The first 12 months of the study consisted of dose-ranging trials, with initial doses of 5 mg/kg each month, then 2.5 mg/kg twice a month, and then 1.15 mg/kg weekly.During the last 2 years of the study, all children were taking 3.5 mg/kg, once a month.The two phase II studies examined somavaratan, which is being developed by Versartis of Menlo Park, Calif.Kevin Yuen, MD, an endocrinologist at the Swedish Medical Center, Seattle, and Wayne V.The women taking estrogen experienced the flattest response, gaining about 2 SDs.However, the response curve was nearly identical, with a rapid, sharp increase in IGF-1 within the first week, followed by a gradual decline to baseline by 22 days.Moore, MD, a pediatric endocrinologist at Children’s Mercy Hospital, Kansas City, Mo., presented the data at the annual meeting of the Endocrine Society.“Despite the fact that human growth hormone is a proven treatment for growth hormone deficiency, daily use of our current formulations can be a factor that affects compliance,” said Dr. He cited a 2008 Misperceptions about the consequences of missed doses and discomfort with injections were strongly associated with noncompliance, the authors of that paper noted.Last year, the Growth Hormone Research Society a consensus paper calling for more research into longer-acting formulations (Eur J Endocrinol. The group of 55 international experts described several strategies for creating long-acting growth hormone formulations, including depot formulations, pegylation, prodrugs, noncovalent albumin binding growth hormone compounds, and growth hormone fusion proteins.These preparations are currently in various stages of development, with some already approved in Europe and Asia.Somavaratan (VRS-317) is a fusion protein produced in . The growth hormone loses some potency in this construct, but its delayed clearance, with a half-life 30-60 times longer than recombinant human growth hormone (rh GH) allows it to exert a prolonged effect in target tissue.