LAB COMPLETES PATIENT ENROLLMENT IN STUDY OF GHRH
Lab International has completed patient enrollment in its pilot growth hormone releasing hormone (GHRH) Phase IIa study. The placebo-controlled Phase II trial being conducted in three centers in Europe is investigating the efficacy and safety of GHRH for the treatment of malnutrition in patients with late-stage pre-dialysis chronic renal failure. The company anticipates demonstrating an increase in growth hormone secretion and IGF-1 levels as well as improvement in protein turnover, body composition, lipid profiles, nutrient intake and biochemical indicators of the nutritional and metabolic states.
"Based on earlier Phase I study results already demonstrating GHRH's strong potency, we believe it has the potential to seriously improve the nutritional status, morbidity and survival rate and even postpone the need for dialysis in many patients," Halvor Jaeger, CEO of Lab International, said.
Growth hormone given in pharmacological doses is known to improve nutritional status in chronic renal failure patients on dialysis despite growth hormone resistance associated with catabolic disease states, according to the company. A better response to growth hormone increase induced by exogenous GHRH can be expected in pre-end-stage renal failure patients since the resistance mechanisms are not as pronounced yet, although many patients are already malnourished.
Lab's proprietary 29 amino-acid peptide analogue of GHRH is designed to stimulate growth hormone secretion in patients. Positive results from its previous Phase I/II trial showed that after administration of GHRH, a rapid and very significant increase in the levels of growth hormones occurred at all dosage levels with no significant adverse events observed.