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news.LAB International has reported positive interim results from its pilot growth hormone releasing hormone Phase II study.
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The placebo controlled, double-blind Phase II trial conducted in three centers in Europe investigated the efficacy and safety of LAB GHRH applied twice daily subcutaneously (1mg/dose) for 28 days in malnourished patients with advanced pre-dialysis chronic renal failure.
Within 4 weeks of treatment, LAB GHRH induced a highly significant stimulation of endogenous growth hormone (GH) secretion and a marked increase of circulating insulin-like growth factor (IGF-1) as compared to placebo in patients with chronic kidney disease. These endocrine effects were associated with a significant increase in fat free mass (FFM) and concomitant reduction in fat mass (FM) when measured by DEXA scan.
While stable isotope studies did not reveal significant changes in protein turnover within 4 weeks of treatment, a trend towards increased protein synthesis in the LAB GHRH arm was observed.
The time-integrated 24-hour endogenous GH concentration after 4 weeks of LAB GHRH was increased 5-fold compared to the pre-treatment levels, whereas no significant change in GH secretion was observed in the placebo group.
In comparison to placebo, LAB GHRH increased fat-free mass (FFM) within 4 weeks of treatment by an average of 2.9 kg. In LAB GHRH group, the mean FFM value increased statistically significantly by 1.8 kg and in placebo decreased by 1.39 kg when compared to baseline. The mean Fat Mass (kg) increased in placebo by 1.2 kg and decreased by 0.5 kg in the LAB GHRH arm when compared to the pre-treatment level. When calculated as ratio of means, total body fat mass % on day 28 was reduced by 17% in LAB GHRH group compared to placebo.
The remaining safety and efficacy parameters of nutritional and metabolic state as well as the final analysis of all the study data collected should be available in Q3 2007.
“We have demonstrated a marked stimulation of growth hormone and IGF-1 production by our compound, which rapidly triggered a remarkable and highly significant increase in lean body mass and decrease in body fat. We believe LAB GHRH has the potential to considerably improve the nutritional status of patients with chronic kidney disease. This should reduce the notoriously high morbidity of these patients and may even postpone the need for dialysis.” said Dr Halvor Jaeger, CEO of LAB International.