SAN DIEGO, May 16 /PRNewswire-FirstCall/ -- Alliance Pharmaceutical Corp. today announces it has received the final approvals required to commence the Phase 2b clinical trial for Oxygent(TM) (perfluorochemical [PFC] emulsion) to prevent post-op ileus resulting from hypoxia during major surgery. The trial will be open for enrollment effective immediately.
About the clinical indication for the Phase 2b study:
During major surgery, the body often reacts by decreasing blood flow to intra-abdominal tissues, thereby conserving blood flow and oxygen supply to vital organs, such as the heart and brain. As a result, gastrointestinal organs receive less oxygen and postoperative bowel function may be impaired.
PFC emulsions have been shown to improve oxygenation to organs and tissues. Clinical evidence for intestinal mucosal protection was obtained during an Oxygent Phase 3 study in which gastric tonometry was performed in a subset of patients at one clinical study site, measuring differences between carbon dioxide tensions in the arterial blood and those in the tonometer balloon (the "CO2 gap"). During cardiopulmonary bypass (CPB), control patients had elevated CO2 gaps and calculated intestinal mucosal pH statistically significantly higher than patients treated with Oxygent, in which these values were normal. This benefit translated into significantly shorter postoperative time to first bowel movement (2 vs. 5 days; p < 0.007) and a strong trend to earlier consumption of solid food (1.8 vs. 4.1 days; p = 0.056) (Frumento et al. Anesth Analg 2002;94 809-14). These clinical endpoints, time to recovery of upper gastrointestinal function (consumption of solid food) and lower gastrointestinal function (bowel movement), have been accepted by the U. S. Food and Drug Administration, as approvable endpoints for Adolor Corporation's Entereg(R) (alvimopan) and Progenics Pharmaceuticals' methylnaltrexone for postoperative ileus associated with opioid analgesics.
About the Phase 2b study design:
This Phase 2b trial will be conducted in six to eight centers in France and will enroll up to 128 patients undergoing primary Coronary Artery Bypass Graft surgery under CPB. In this double-blind, randomized, controlled dose-escalation study, patients will receive either a dose of saline or a dose of Oxygent 5-10 minutes before bypass is commenced. Three dose levels (1.5, 3.0 and 4.5 ml/kg) will be administered and, at the end of each dose level, safety and efficacy will be evaluated.
About Alliance Pharmaceutical Corp.:
Alliance Pharmaceutical Corp. is a development-stage pharmaceutical company that is currently focused on developing its lead product, Oxygent, which is based on its proprietary PFC technology. Oxygent is being developed as an intravascular oxygen carrier designed to augment oxygen delivery in surgical patients.
Except for historical information, the matters set forth in this release are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth herein. Alliance refers you to cautionary information contained in documents Alliance files with the Securities and Exchange Commission from time to time, including the last Form 10-KSB and Form 10-QSB. Alliance is under no obligation (and expressly disclaims any obligation) to update or alter its forward-looking statements, whether as a result of new information, future events, or otherwise.
Alliance Pharmaceutical Corp.