Laval, AC – Drug development company LAB International says that, after completion of a successful dose-response trial, it has selected the first clinical indication for which it intends to evaluate the efficacy of its Growth Hormone Releasing Hormone (GHRH) analogue. GHRH will be evaluated for the treatment of malnutrition in patients with late pre-end-stage chronic renal failure (CRF, stage 4, pre-dialysis) in a phase II trial to be initiated during the first half of 2005.
“It is estimated that approximately 45% of the 400,000 stage 4 CRF patients in the United States also suffer from malnutrition and that this condition is not properly addressed with current treatment options,” says Dr Halvor Jaeger, CEO of LAB. “We anticipate that, based on the potency our drug demonstrated in our recently completed Phase I/II study, GHRH will provide therapeutic benefits to the nutritional status of these specific patients.”
LAB’s proprietary 29 amino-acid peptide analogue of GHRH is designed to stimulate growth hormone secretion in patients. In September, LAB announced positive results from a phase I/II trial which showed that after administration of GHRH, a rapid and very significant increase in the levels of growth hormones occurred at all dosage levels. Moreover, the company says the study demonstrated the high safety profile of GHRH at all doses administered with no significant adverse events observed.
“Although growth hormone is known to improve nutritional status in CRF patients on dialysis, there is also associated growth hormone resistance at that specific stage. A better response to growth hormone at physiological concentrations can be expected in pre-end-stage CRF patients because the resistance mechanisms are not as pronounced yet many of these patients are already malnourished,” says Dr Franz Schaefer, professor of pediatrics and nephrology at the University of Heidelberg, Germany. “By improving the nutritional status of patients at this stage of chronic renal failure, even the need for dialysis might be postponed, resulting in less morbidity to patients and significant savings to the healthcare system. Also a distinct advantage of our GHRH can be expected in patients with concomitant diabetes.”
CRF is a gradual and progressive loss of the ability of the kidneys to excrete wastes, concentrate urine and conserve electrolytes. CRF usually develops over a number of years as the internal structures of the kidney are slowly damaged. Late pre-end-stage CRF is characterized by a low total rate of filtration of blood by the kidney (15-25 mL/min per 1.73 m(2)). Diabetes and hypertension are the two most common causes of CRF.