Alliance Pharmaceutical Corp. Announces American Society of Anesthesiology Presentation Re. Oxygenation Benefits of Oxygent in Cardiac Surgery Patients.

Business Editors/Health & Medical Writers

BIOWIRE2K

SAN DIEGO--(BW HealthWire)--Oct. 19, 2001

Alliance Pharmaceutical Corp. (Nasdaq:ALLP) and (ALLPD) announced today that data demonstrating oxygenation benefits provided by Oxygent(TM) (perflubron emulsion) in a subset of patients enrolled in a Phase 3 cardiac surgery study was presented at the American Society of Anesthesiology meeting held this week.

Elliott Bennett-Guerrero, MD, chief of cardiothoracic anesthesiology at Columbia University College of Physicians & Surgeons in New York, reported that administration of Oxygent, an intravenous oxygen carrier, prevented gastrointestinal tract ischemia (oxygen deprivation) and may preserve post-operative GI tract function. Preservation of gastric function and integrity could decrease some of the post-operative complications common to cardiac surgery patients.

Nine patients undergoing cardiopulmonary bypass procedures were instrumented for gastric tonometry for GI data analysis. This subset study was conducted at Columbia University to determine the feasibility of using direct measurements of hemodynamics and oxygen delivery to assess the function of a key organ system.

Dr. Bennett-Guerrero, principal investigator of the GI study, noted that patients treated with Oxygent had a statistically significant (p less than 0.007) shorter time to first bowel movement post-operatively (2.0 days vs. 5.4 days for the control group). The Oxygent-treated patients also had a shorter time to consumption of solid food (1.8 days vs. 4.1 days), which almost achieved statistical significance (p=0.056). This data may indicate that Oxygent provides a valuable clinical benefit, since more than 50 percent of cardiac bypass patients typically experience post-operative gastrointestinal symptoms such as poor appetite, nausea, and constipation. The intra-operative risk of gut ischemia and the resulting post-operative symptoms and lack of normal bowl function are even more common following non-cardiac surgery of the abdominopelvic cavity, and in critically ill patients in the intensive care unit.

"A potentially important use of Oxygent relates to its theoretical ability to deliver oxygen to tissues with poor microcirculatory blood flow," stated Dr. Bennett-Guerrero, chief of cardiothoracic surgery at Columbia University. "The administration of Oxygent improves tissue oxygenation and thereby may reduce some types of organ dysfunction in high-risk surgical patients."

Gastric tonometry is the only clinically available U.S. Food and Drug Administration (FDA) approved method for monitoring the oxygenation status of the GI system. "It is noteworthy that the improvement in gastric tonometric variables was statistically different between the groups at multiple time points, despite the small number of patients," Dr. Bennett-Guerrero explained. "Abnormal gastric tonometric variables have been shown to be associated with the subsequent development of GI tract complications. All patients in the Oxygent group maintained normal variables throughout the intra- and post-operative periods, whereas the control group showed significant deterioration.

"The Oxygent patients also exhibited a faster return of GI tract motility post-operatively," Dr. Bennett-Guerrero said. "It appears that Oxygent actually protects the tissues, and the preservation of tonometric variables appears to translate into a clinically relevant benefit."

A manuscript with additional details from the patients evaluated for gastric performance has been submitted for publication in a peer-reviewed medical journal. These patients were a subset of the larger Phase 3 cardiac surgery study, which was suspended voluntarily earlier this year due to an imbalance in certain adverse events. A preliminary data analysis that explained reasons for the imbalance, particularly that these events were not directly related to Oxygent, but resulted from procedures specified in the protocol, has been presented to the FDA by Alliance. A final report that includes support for the design of a new study will be submitted to the FDA later this year.

In addition to the Phase 3 cardiac surgery study, Oxygent has been evaluated in a multi-national Phase 3 study with 492 general surgery patients. Results from this study demonstrated that treatment with Oxygent provided a statistically significant reduction and avoidance of donor blood usage. Oxygent is a sterile perfluorochemical emulsion that does not contain human or animal blood components. It is universally compatible with all blood types, has a shelf-life of approximately 2 years, and is manufactured in a large-scale facility using commercially available raw materials.

Alliance Pharmaceutical Corp. is developing therapeutic and diagnostic products based on its perfluorochemical and surfactant technologies. Alliance's products are intended primarily for use during acute care situations, including surgical, cardiology, and respiratory applications. Oxygent is being developed in the United States, Canada, and Europe in conjunction with Baxter Healthcare Corp. Imavist(TM), an ultrasound contrast agent, is being developed jointly by Alliance and Schering AG, Germany. The FDA has reviewed a New Drug Application for Imavist and found it to be approvable upon satisfactory response to issues identified in the review process. Alliance recently submitted documentation to the FDA that it believes fully addresses these issues, and the company is therefore expecting final approval and permission for marketing Imavist in the U.S. Additional information about the company is available on Alliance's Web site at www.allp.com.

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, including the availability of funding for development, the uncertainties associated with the conduct of preclinical or clinical studies and the timing or ability to investigate scientific data. Alliance refers you to cautionary information contained in documents the company files with the Securities and Exchange Commission from time to time, including the last Form 10-K and Form 10-Q, and those risk factors set forth in the most recent registration statement on Form S-3 (File No. 333-47032) and Form S-4 (File No. 333-49676). 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.