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Tranzyme Pharma Presents Initial Phase IIa Data for its Novel,Ghrelin Agonist, TZP-101, in Patients with Diabetic Gastroparesis

RESEARCH TRIANGLE PARK, N.C. & SHERBROOKE, Quebec--(BUSINESS WIRE)--Jun 26, 2007 - Tranzyme Pharma, a leading biopharmaceutical company developing small molecule drugs for the treatment of gastrointestinal and metabolic diseases, today announced positive results for its novel ghrelin agonist, TZP-101, in accelerating gastric emptying in diabetic patients with gastroparesis. The data from a pilot Phase IIa study were presented at the American Diabetes Association's 67th Scientific Sessions in Chicago, IL by Dr. Gordana Kosutic, Tranzyme's VP of Clinical and Regulatory Affairs. Tranzyme is developing TZP-101 as a first-in-class gastroprokinetic agent for the treatment of severe gastroparesis and post-operative ileus (POI).

Using scintigraphy and a standardized meal, this double blind, randomized, four-way crossover study assessed the efficacy of three different dose levels of TZP-101 on gastric emptying in patients with long standing Type 1 diabetes and severe gastroparesis. The data showed that TZP-101 significantly accelerated gastric emptying at all doses tested, whereas placebo had no effect. These results suggest that TZP-101 is a promising agent for the management of gastroparesis and that further investigation is warranted.

"These data are very encouraging and I am looking forward to continuing with the clinical investigation of TZP-101 in patients with severe diabetic gastroparesis, as ghrelin is one of the most attractive targets for the therapeutic management of this serious medical condition," said Dr. Niels Ejskjaer, principal investigator from the Aarhus University Hospital, Denmark.

Gastroparesis is a disorder characterized by delayed emptying of food from the stomach. It exists in mild to moderate (chronic) and severe (acute) forms and is a common disorder among diabetics, and others with impaired gastric autonomic nerve function. In severe cases, patients may require hospitalizat
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