SAN DIEGO, Nov. 7 /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 reported that the German Competent Authority (regulatory agency) completed its review and approved the start of the Phase 2 clinical trial for Oxygent to prevent post-op ileus resulting from hypoxia during major surgery; however, the relevant German Ethics Committee responded with a negative vote on the protocol based upon risk/benefit in the cardiac patient population selected. Alliance appealed the negative decision, and offered additional clarifications and supporting data for the protocol, but the German Ethics Committee has informed us that it has declined approval of the study protocol as submitted. Alliance is now proceeding to explore other options available in Germany, one of which may be the submission of a revised protocol.
The French Competent Authority is continuing its consideration of our submission and we have responded to several of its review questions. The relevant French Ethics Committee has approved the start of the trial. We believe that if we receive the Competent Authority approval by the end of the calendar year, we could initiate and complete the clinical trial in 2007. We estimate that we have sufficient funds to implement this scenario. If significant adjustments need to be made to the protocol to make it acceptable for approval, then we may need additional funds to complete the study.
In addition, Alliance has successfully completed the technology transfer to its contract manufacturer for the production of clinical trial material. Clinical supplies are currently being produced to meet the requirements of the above clinical studies and to supply our partner in China, Beijing Double-Crane Pharmaceutical Co. Ltd. (Double-Crane). We anticipate that Double-Crane will complete their submission to the sFDA and initiate their clinical development of Oxygent in 2007.
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. 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.