SAN DIEGO, July 31 /PRNewswire-FirstCall/ -- Alliance Pharmaceutical Corp. today announces the following update with regard to the development of Oxygent(TM) (perfluorochemical (PFC) emulsion) to prevent post-op ileus resulting from hypoxia during major surgery.
Earlier this year, Alliance applied to the Competent Authorities and to the Ethics Committees (equivalent to Investigational Review Board [IRB] in the U.S.) in France and Germany to proceed with the start of a Phase 2 Proof of Concept clinical trial. The objective of the study will be to show the safety and demonstrate the efficacy of Oxygent to improve post-op gut function. The study is expected to enroll approximately 65 patients.
The French and German Competent Authorities responded with additional questions to the submission and Alliance responded to these questions. The German Competent Authority has completed its review and approved the start of the Phase 2 trial; however, the relevant German Ethics Committee has responded with a negative vote based upon risk/benefit of the protocol. Alliance is now proceeding with the formal appeal process to enable it to initiate the trial in Germany. We are currently awaiting a response from the French Competent Authority. The relevant French Ethics Committee has approved the start of the trial.
As a result of the timeframe of the French review and German appeal process, and assuming we can successfully address the issues raised by each, the earliest we could start this Phase 2 clinical trial would be during the 4th quarter of this year. We believe we have sufficient funds to complete the study if it commences in this timeframe.
In addition, Alliance has progressed with its contract manufacturer in the production of clinical trial material. We have identified the process for clinical production and are completing the method transfer and validation steps required to move forward with clinical lot production.
About the clinical indication for the Proof of Concept 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 by looking at differences between carbon dioxide tensions in the arterial blood and those in the tonometer balloon (the "CO2 gap"). During cardiopulmonary by-pass, 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 FDA, as approvable endpoints for Adolor Corporation's Entereg(R) (alvimopan) and Progenics Pharmaceuticals' methylnaltrexone for postoperative ileus associated with opioid analgesics.
About Alliance Pharmaceutical Corp.:
Alliance Pharmaceutical Corp., founded in 1989, 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, and those risk factors set forth in the most recent registration statement on Form SB-2 (File No. 333-119428). 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.