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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 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.
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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.
The adverse event profile was not quite as benign as it was in the pediatric study.
Virtually all patients experienced at least one adverse event. The rest were serious, with one severe and one life-threatening event. Yuen did not discuss adverse events; these were, however, included in supplementary slides available on the Versartis Inc. The finding of a predictable, 3-week tailing-off of efficacy, combined with the fact that patients responded so dramatically, exceeding the maximum target of a 1.5 SDs increase in IGF-1, has prompted a new dosing protocol for the somavaratan open-label extension , which includes all the phase II completers, plus an additional 40 adult patients. Moore has received research support from the company.
Cohort B comprised six men and women younger than 35 years, who took 0.8 mg/kg per month.
Cohort C comprised eight women taking oral estrogen contraceptives. The cohorts were similar in body mass index and weight, but they did differ significantly in baseline IGF-1 levels. In cohort B, it was 2.89 SDs below normal, and in cohort C, it was 2.29 SDs below.
These findings were almost superimposable with those in the ANSWER registry. At baseline, the mean hemoglobin A was 5.2%; this was unchanged at 3 years. The most commonly reported adverse event was injection site pain (48%).
Bone age and chronological age came into alignment within the first year and that association was maintained throughout the study – again, in almost superimposable curves with the registry data. Injection site erythema was reported in 5% of patients, but no injection site nodules occurred.
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.