Treatment With Geref Shows Positive Catch-Up Growth For GHD
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Treatment With Geref Shows Positive Catch-Up Growth For GHD

KANSAS CITY, MO and NEW ORLEANS, LA -- May 4, 1998 -- Children treated for growth hormone deficiency (GHD) using Serono Laboratories’ growth hormone releasing hormone (GHRH) Geref(R) (sermorelin acetate for injection) showed continued significant responses to therapy in all major measures of growth after their second year of therapy, according to findings of a multi-centre, international study. The study also demonstrated important findings in two subsets of patients treated for three and seven years.

Data from the study were published in a poster presentation at the annual meeting of the Pediatric Academic Society and the Lawson Wilkin's Pediatric Endocrine Society in New Orleans.

The study showed that one and two-year height velocity (HV), height standard deviation score (HTSDS) and height velocity standard deviation (HVSDS) changed significantly over the course of treatment. After 36 months, HV continued to improve and all subjects had significant catch-up growth. The study also showed a positive trend toward catch-up growth in all children treated for one, two and three years and two children treated for seven years, whereby the children continued to catch-up to their appropriate height for age, gender and genetic predisposition. The two patients in seventh year of treatment have moved to a growth centile similar to their peers of normal height.

"This study demonstrated that treatment with Geref can provide important benefits over a multi-year course of treatment and that it may help some children to reach a height and weight appropriate for their age, gender and genetic potential,” said Campbell Howard, M.D., section chief for endocrinology/diabetes and medical staff president at Children's Mercy Hospital in Kansas City, MO. and associate professor of pediatrics at the University of Missouri, Kansas City School of Medicine. “In addition, the study has shown that in selected patients, Geref produces a long-term growth rate comparable to that achieved through traditional therapy for GHD.

"The results of this study are another indication that GHRH is an efficacious alternative for treating GHD. These findings also illustrate the importance of diagnosing and treating GHD as early as possible in order to help these children achieve their full growth potential.”

Geref offers a new approach to treating GHD and was launched in April. It is (GH) in children with natural, unused bodily reserves. Traditionally, GHD has been treated by replacing natural GH with recombinant growth hormone.

In this international, multicentre study, 27 children in four countries were treated with 30 ug/kg of Geref subcutaneously, once daily at bedtime. Significant results were reported for HV, HTSDS and HVSDS at 12, 24 and 36 months. At three years, HV had increased from a baseline of 4.4+/- 1.06 cm/yr to 5.34 +/- -1.39 cm/yr, while HTSDS improved from -3.59 +/- 0.66 to -2.49 +/- 0.86, and HVSDS changed from -2.24 +/- 1.16 to -0.81 +/- 1.59. In two subjects treated over seven years, changes in HTSDS from -3.03 to -1.35 and -2.76 to -0.80 were reported. In each of these subjects, the average HV was 6.09 +/- 2.07 (SD) and 7.40 +/- 2.07 cm/yr over the seven-year treatment period.

GHD, which inhibits skeletal growth, occurs in one out of every 3,500 children, according to the Human Growth Foundation. Although GHD can be diagnosed in infancy, most children are not diagnosed and treated until much later. GHD results from an abnormally low level of endogenous pituitary human growth hormone (hGH); injury or damage to the pituitary or its signal pathway; or from a chemical malfunction whereby GHRH fails to trigger the release of hGH from the pituitary. When GHRH is at fault, the result is unused bodily stores of hGH.

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