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Weekly TransCon Growth Hormone for the Treatment of Growth Hormone Deficiency

Information contained on this page is provided by an independent third party content provider. WorldNow and this Station make no warranties or representations in connection therewith.Interim analysis shows annualized three month height velocity "Anadrol 50" is Bivirkninger comparable to the active comparator, Genotropin, given at an equivalent cumulative weekly doseCOPENHAGEN, Denmark, Sept. 16, 2014 /PRNewswire/ Ascendis Pharma A/S, a biotechnology company that applies its innovative TransCon technology to address significant unmet medical needs, today announced positive interim results from its ongoing Phase 2 pediatric study to evaluate once weekly TransCon Growth Hormone in children with growth hormone deficiency, or GHD. The full interim results will be presented at the 7th International Congress of the GRS and IGF Society, being held October 15 18, 2014, in Singapore. Dr. Key conclusions from the interim analysis include:mean annualized height velocities ranged from 13.0 cm to 14.1 cm for the three weekly dose levels of TransCon Growth Hormone, which were comparable to the active comparator, daily injections of Genotropin;there have been no reports of serious or unexpected adverse events;injection site reactions were generally mild and transient and occurred in only a few patients;thus far, there have been no observations of injection site nodule formation or lipoatrophy; anda dose proportional increase in IGF I levels was observed following dosing of the three TransCon Growth Hormone doses. Transient point values of IGF I SDS > +2 have been observed in a Oral Steroids Poison Oak small number of patients and only in the high dose treatment arm.The ongoing Phase 2 pediatric study is being conducted to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of TransCon Growth Hormone in up to 52 treatment nave pre pubertal patients with GHD, who meet internationally recognized criteria for GHD. The study is a 6 month multi center, randomized study comparing three dose levels of TransCon Growth Hormone (0.14; 0.21; and 0.30 mg hGH/kg/week), administered once per week, to the active control Genotropin (0.21 mg hGH/kg/week), administered as 7 daily injections. The Primobolan 1ml efficacy endpoint is height velocity at six months. The protocol for the Phase 2 pediatric study calls for two interim data analyses. This interim analysis reports height velocity in 50% of the evaluable patients completing the first three months of the study. In the first quarter of 2015, Ascendis Pharma plans to report six month height velocity data from 50% 4-chlorodehydromethyltestosteron of the patients completing the Phase 2 pediatric study, and top line data for all patients in the study in mid 2015.About Growth Hormone DeficiencyGrowth hormone deficiency, or GHD, is a serious orphan disease affecting both children and adults. In children, GHD manifests with short stature, metabolic abnormalities, cognitive deficiencies and poor quality of life. 4-chlorodehydromethyltestosteron Adult GHD is associated with premature mortality and neuropsychiatric cognitive, cardiovascular, neuromuscular, metabolic and skeletal abnormalities. The market for daily injections of human growth hormone was approximately $3 billion in 2013. There are currently no long acting growth hormone treatment options available in the United States or Europe.The current standard of care for the treatment of GHD requires patients to receive daily injections over many years. The administrative burden of daily injections often results in poor patient compliance and can lead to suboptimal treatment outcomes.Ascendis Pharma is developing once weekly TransCon Growth Hormone, an investigational new drug, to address the burden of daily injections and suboptimal treatment outcomes that can result from poor patient compliance. TransCon Growth Hormone is a prodrug that releases unmodified growth hormone, thus maintaining the same mode of action as currently prescribed daily growth hormone therapies. Clinical studies of TransCon Growth Comprar Levitra Hormone have demonstrated a comparable efficacy, safety, tolerability and immunogenic profile to that of daily growth hormone. If approved, TransCon Growth Hormone may reduce the burden of daily treatment by requiring significantly fewer Methandienone Tablets Price In India injections, which may improve patient compliance and treatment outcomes. Ascendis Pharma has successfully completed a Phase 2 study of TransCon Growth Hormone in adults with GHD and is currently enrolling children with GHD in a Phase 2 pediatric study. Ascendis Pharma expects to report interim data from its Phase 2 pediatric study in the first quarter of 2015, and top line data in mid 2015. Ascendis Pharma also plans to develop TransCon Treprostinil for the treatment of pulmonary arterial hypertension. In addition to its proprietary programs, Ascendis Pharma has formed collaborations focused on leading products in large markets that are of strategic importance to its collaborators.