Gastrotech Pharma A/S Initiates New Clinical Phase II Cancer Cachexia Study
COPENHAGEN, February 9 /PRNewswire/ -- Gastrotech Pharma A/S announced today that it has initiated a new clinical phase II study of GTP-200 in cancer cachexia patients. The study is designed as a double blind, randomized, controlled study in 30 patients with end-stage cancer and significant weight loss. The principal investigator for this single center trial is Professor Kent Lundholm from Sahlgrenska University Hospital in Gothenburg, Sweden. Professor Lundholm is a world renowned expert on cancer cachexia and has published extensively in this field.
Gastrotech recently announced the completion of a phase I/II study of GTP-200 in cancer cachexia study. The analysis of the full data package is still on-going, but the treatment proved safe and several important effects were observed. These data were included in an abstract submitted to the up-coming American Society of Clinical Oncology ("ASCO") meeting. ASCO rules prevent public disclosure of data prior to the meeting, which is held June 2-6, 2006. The positive outcome of this study led to the initiation of the new study.
Patients in Professor Lundholm's 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" says Professor Lundholm. "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"
Dr. Hans Schambye, CEO of Gastrotech says: "We are pleased to be able to continue the development of GTP-200 after the successful completion of our first study. Professor Lundholm has served as an advisor to Gastrotech since its inception and has been a tremendous help for the company."
About GTP-200
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.
About Cancer Cachexia
Cancer cachexia or cancer wasting is a potentially life threatening condition that affects approximately 50% of all cancer patients, with variable frequency in different tumor types and stages. Cancer cachexia is characterized by abnormal weight loss due to decreased appetite and food-intake as well as loss of fat and muscle mass. The condition is a significant factor in the poor performance and high mortality rate of cancer patients.
About Gastrotech Pharma A/S
Gastrotech Pharma A/S is a clinical stage biotech company focused on development of innovative new therapeutics for significant unmet medical needs. Gastrotech's therapeutics are based on naturally occurring peptide hormones, which have a much more attractive risk-reward profile than traditional small-molecule based compounds.
Gastrotech has two programs in clinical development: GTP-010 for Irritable Bowel Syndrome, which is developed in partnership with Eli Lilly & Co., and GTP-200 for the treatment of cachexia and other catabolic syndromes.
More information is available at www.gastrotechpharma.com.
Gastrotech Pharma A/ SCONTACT: For further information contact: Dr. Hans Schambye, CEO,Gastrotech Pharma A/S, at +45-33-44-42-42