The study is designed as a double blind, randomized, controlled study in 30 patients with end-stage cancer and significant weight loss. The study follows the recent completion of a phase I/II study of GTP-200 in cancer cachexia (wasting) study. The data analysis is still on-going, but the treatment proved safe and several important effects were observed in this trial.
Patients in the new study will be treated with daily injections of two different dosages of GTP-200 for a total of 8 weeks. The primary goal of the study is to evaluate the effect of GTP-200 on key parameters such as body weight, body composition, appetite and quality of life. The study is expected to be completed in the first quarter of 2007.
“Cancer cachexia patients have very limited treatment options today” said Professor Kent Lundholm, from Sahlgrenska University Hospital in Gothenburg, and lead investigator. “GTP-200 is a promising new treatment since it appears to both stimulate appetite and muscle mass. I look very much forward to running this study”
GTP-200 is based on the naturally occurring peptide hormone, ghrelin. Ghrelin has previously been shown to be a potent stimulator of appetite and food intake in both normal individuals and patients. Furthermore, ghrelin has been shown to increase the muscle and fat mass.
This is one of two clinical programs Gastrotech has on the go at the moment, the other is for the development of GTP-010 for irritable bowel syndrome, which is developed in partnership with Eli Lilly.