Tranzyme Pharma's Successful Phase 2 Postoperative Ileus Trial Results to be Presented at the American Society of Colon and Rectal Surgeons 2009 Annual Meeting
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--May 4, 2009 - Tranzyme Pharma today announced that Anthony J. Senagore, MD, MBA, MS, FACS, Vice President, Research & Education of Spectrum Health and Professor of Surgery, Michigan State University/CHM, will present results from the successful study of ghrelin agonist TZP-101 for the management of postoperative ileus (POI) at the upcoming 2009 Annual Meeting of the American Society of Colon and Rectal Surgeons (ASCRS) being held from May 2-6, 2009. Dr. Senagore's presentation will take place on Wednesday, May 6, 2009 at 4:50 p.m. EST in the Atlantic Ballroom of the Westin Diplomat Hotel in Hollywood, FL.
POI is a transient impairment of gastrointestinal (GI) function following abdominal or other surgery and is often protracted and exacerbated by multiple factors including the use of opioids for pain management. Symptoms include abdominal distention, pain, nausea and vomiting, and inability to pass stools and tolerate a solid diet. Delays in resuming a normal diet may lead to poor wound healing and increased risk of infection through a cascade of events. POI is associated with an increased length of hospital stay and is the most common cause of delayed hospital discharge after abdominal surgery. The prolonged hospitalization raises the possibility for serious pulmonary complications. In the United States alone, 2.4 million patients undergo open abdominal surgery each year and are at high risk for POI (Source: Premier Database). No unrestricted treatments for POI have been approved by the US Food and Drug Administration to date.
Tranzyme is planning a Phase 3 trial with TZP-101 for POI with the primary efficacy endpoint of “GI2” - the time to GI function recovery as defined by the later of first bowel movement (BM) and first solid food intake. The Phase 2 study (which enrolled ~250 patients undergoing partial large bowel resection) demonstrated TZP-101's ability to reduce the time to GI2 by 23.3 hours over placebo (PBO), and that difference is clinically and statistically significant (p<0.05). Another clinically important endpoint, the proportion of patients who had early recovery of GI function (within 72 hours) indicated a marked increase on TZP-101 (65% of patients) over placebo (25% of patients). The observed difference was evidently significant (p=0.004). The most typical adverse events for the post-surgical population, nausea and vomiting, were noticeably decreased in the TZP-101 group as compared to placebo. In the placebo group, nausea and vomiting were reported for 27% and 16% patients, respectively. In contrast, for the two most effective study doses, fewer than 5% of TZP-101 patients experienced nausea or vomiting, consistent with the strong GI prokinetic activity of TZP-101 and the early GI recovery.
About Tranzyme Pharma
Tranzyme Pharma is a late stage biopharmaceutical company engaged in the discovery and development of first-in-class small molecule therapeutics for the treatment of both acute care (hospital-based) and chronic indications with significant unmet medical needs.
Posted: May 2009