Pharmaceutical Business review

Lab International initiates malnutrition and renal failure study

The placebo controlled phase II trial to be conducted in a single center in Europe is investigating the efficacy and safety of growth hormone releasing hormone (GHRH).

A total of 32 patients will be enrolled in the study, which is expected to be completed before the end of the year. The company anticipates demonstrating an increase in growth hormone secretion levels as well as other surrogate markers such as IGF-1 and improvement in biochemical indicators of the nutritional and metabolic state.

Lab reports that an estimated 45% of the 400,000 late pre-dialysis chronic renal failure patients in the US suffer from malnutrition. “Successful reversal of uremic catabolism in pre-dialytic chronic renal failure is expected to improve patient morbidity and survival in this population, and possibly even postpone the need for dialysis in many patients,” said Dr Taneli Jouhikainen, president of Lab.