Tranzyme Pharma Expands Clinical Program of its Novel Ghrelin Agonist, TZP-101, to Include Patients with Gastroparesis.RESEARCH TRIANGLE PARK Research Triangle Park, research, business, medical, and educational complex situated in central North Carolina. It has an area of 6,900 acres (2,795 hectares) and is 8 × 2 mi (13 × 3 km) in size. Named for the triangle formed by Duke Univ. , N.C. & SHERBROOKE, Quebec “Sherbrooke” redirects here. For other uses, see Sherbrooke (disambiguation). Sherbrooke (2006 population: 147,427) is a city in south-eastern Quebec, Canada, the only major city in the Eastern Townships. -- Tranzyme Pharma announced today that the Company has amended the IND for its novel small molecule ghrelin agonist agonist /ag·o·nist/ (ag´ah-nist) 1. one involved in a struggle or competition. 2. agonistic muscle. 3. , TZP-101, to include patients with gastroparesis. Tranzyme has been developing TZP-101 as a potent prokinetic agent for the treatment of post-operative ileus Ileus Definition Ileus is a partial or complete non-mechanical blockage of the small and/or large intestine. The term "ileus" comes from the Latin word for colic. (POI). Under the amended IND, Tranzyme has initiated a single-dose study in diabetic patients suffering from gastroparesis. This new study will provide a lead-in to more detailed Phase II evaluation of TZP-101 in both POI and gastroparesis. Gastroparesis is a gastrointestinal disorder Noun 1. gastrointestinal disorder - illness caused by poisonous or contaminated food food poisoning illness, sickness, unwellness, malady - impairment of normal physiological function affecting part or all of an organism characterized by delayed emptying of the stomach. It exists in acute and chronic forms and is a common disorder among patients with diabetes. Patients presenting with acute episodes of gastroparesis require immediate hospitalization to manage pain, nausea, vomiting, glucose dysregulation, fluid and electrolyte imbalance electrolyte imbalance Critical care A general term for a derangement of major electrolytes–Na+, K+, chloride; thus defined, EI is common; in practice, EIs are only of interest if they cause clinical disease , and potential malnutrition. The most potent product for treating gastroparesis, Propulsid(R) (cisapride), achieved $1 billion in global sales, but was withdrawn from the market in 2000 due to adverse side effects Side effects Effects of a proposed project on other parts of the firm. . "The Company is making significant progress in the development of TZP-101," said Gordana Kosutic, M.D., VP, Clinical & Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: In a previous Phase I single-dose study, Tranzyme reported that TZP-101 demonstrated excellent tolerability and safety, and a desirable pharmacokinetic profile in healthy subjects. The Company plans to initiate full Phase II development of TZP-101 in early 2007. In addition to the ongoing clinical testing of TZP-101, Tranzyme is developing a second generation ghrelin agonist, TZP-102, as an oral product. Tranzyme expects to initiate Phase I clinical testing of TZP-102 in the second half of 2007 for the treatment of mild to moderately severe gastroparesis. "TZP-101 and TZP-102 are promising first-in-class drugs with tremendous commercial potential", said Vipin K. Garg, Ph.D., President & CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Tranzyme Pharma. "Unlike TZP-101, most prokinetic agents under development and on the market target the central nervous system with potentially serious side effects. The amended IND represents a significant milestone for Tranzyme Pharma as TZP-101 is the Company's first product to be dosed in patients." Tranzyme Pharma is a clinical-stage biopharmaceutical company developing small molecule therapeutics for the treatment of gastrointestinal (GI) and metabolic diseases. Tranzyme's candidate drugs, which were discovered and optimized using the Company's proprietary chemistry technology, include compounds with high potency and selectivity for validated and druggable targets. Tranzyme is developing first-in-class, mechanism-based therapeutics for post-operative ileus (POI), gastroparesis, obesity, diabetes and intestinal hypermotility. For more information, please visit: www.tranzyme.com. |
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