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Tranzyme Pharma Initiates Dosing in Humans With Second Drug Candidate TZP-102

Posted on: Monday, 3 March 2008, 06:00 CST

Tranzyme Pharma today announced that it has commenced dosing in a Phase I study of TZP-102, the Company's second generation, orally-administered ghrelin agonist. TZP-102 is a potent prokinetic agent that Tranzyme is initially developing for the treatment of mild-to-moderate gastroparesis, with other chronic gastrointestinal (GI) motility disorders to follow.

The Phase I trial is a two-part double-blind, placebo-controlled evaluation of single ascending doses, followed by a crossover multi-dose evaluation in healthy human volunteers. In addition to safety, other objectives of the study include the assessment of pharmacokinetic properties and pharmacodynamic effects of ghrelin receptor agonist activity.

Tranzyme develops small molecule drugs from its proprietary macrocyclic chemistry platform, MATCH(TM), for the treatment of GI and metabolic diseases. TZP-102 operates through the same mechanism of action as the lead drug, TZP-101, an intravenous ghrelin agonist currently undergoing Phase IIb trials for the treatment of post-operative ileus (POI) and severe gastroparesis.

"We are very excited to begin characterizing the safety and tolerability of TZP-102," said Gordana Kosutic, M.D., Tranzyme's Vice President, Regulatory and Clinical Affairs. "We anticipate progressing TZP-102 into Phase II investigation by the end of this year."

"Gastrointestinal disorders are expected to affect over 250 million people worldwide by 2012," stated Vipin K. Garg, Ph.D., President & CEO of Tranzyme Pharma. "Having two GI promotility drug candidates in the clinic is a great milestone for Tranzyme, and is extremely encouraging for patients and caregivers alike since many competing promotility agents have safety issues that have resulted in their restriction or removal from the market."

About Gastroparesis

Gastroparesis is an impairment or paralysis of upper gastrointestinal tract function characterized by delayed gastric emptying in the absence of mechanical obstruction. Symptoms of gastroparesis include post-prandial fullness, early satiety, abdominal pain, nausea, vomiting, and weight loss. Disease severity ranges from mild to moderate to severe. Gastroparesis is a major complication of diabetes leading to metabolic imbalance when liquid and food intake and absorption of oral medications is impaired. Gastroparesis may also result from abdominal surgery or be idiopathic in nature. Current medications for the treatment of gastroparesis are only moderately effective and many are associated with adverse neurological side effects. It is estimated that approximately 5 million patients suffer from gastroparesis in the United States.

About Tranzyme Pharma

Tranzyme Pharma is a clinical stage biopharmaceutical company focused on developing and commercializing breakthrough small molecule therapeutics for diseases where there is a significant unmet medical need. Tranzyme has developed a pipeline of novel drugs for the treatment of gastrointestinal and metabolic diseases. For more information, please visit: www.tranzyme.com.

 Contacts:  Vipin K. Garg, Ph.D. President and CEO (919) 313-4764 Email Contact  Gordana Kosutic, M.D. VP, Regulatory & Clinical Affairs (919) 313-4765 Email Contact  Susan S. Josselyn Corporate Communications Mgr. (919) 313-4761 Email Contact

SOURCE: Tranzyme Pharma

Source: MARKET WIRE

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