Alliance Pharmaceutical Corp. Announces Presentation of Phase 3 General Surgery Efficacy Results Demonstrating Benefit of Oxygent in Reduction and Avoidance of Blood Transfusions.

Health/Medical Writers

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SAN DIEGO--(BW HealthWire)--April 9, 2001

Alliance Pharmaceutical Corp. (Nasdaq:ALLP) announced today that the average (median) number of units of blood required by the control patients was twice the number of units of blood required by patients treated with OxygentTM (perflubron emulsion) in an international Phase 3 study with 492 general surgery patients. These results, which were presented by the lead study investigator, Prof. Donat R. Spahn, MD, at the European Society of Anesthesiology Annual Meeting in Gothenburg, Sweden, demonstrate that Oxygent has the potential to help alleviate blood shortages by providing a significant saving in the amount of blood used during certain surgeries. Oxygent is an intravascular oxygen carrier that does not contain any human or animal blood components. Alliance is developing the product in the United States, Canada, and Europe in conjunction with Baxter Healthcare Corporation.

"This study is a milestone in the development of artificial oxygen carriers and transfusion alternatives," said Dr. Spahn, who is the newly appointed Professor and Chairman of the Department of Anesthesiology at the Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland. He noted that the primary and secondary endpoints of the study, reduction and avoidance of blood transfusion, respectively, were achieved with statistical significance in both the protocol-defined target group of patients and the total population of all patients enrolled in the study.

The target group was defined as patients for whom a transfusion is most likely to be needed, i.e., those with moderate to high blood loss. Two-thirds of the study patients (N=330) met these criteria, experiencing from 20 mL to more than 80 mL blood loss per kilogram body weight. The benefit provided by Oxygent treatment was particularly evident in this population. In regard to transfusion avoidance, almost twice as many patients in the target group completely avoided the need for a transfusion compared to the control group, an approximately 100% relative improvement in blood avoidance. For patients who did need blood transfusions, those in the target group who received Oxygent required an average of only two units of blood, compared to four units of blood for the control patients. Both the avoidance (p=0.006) and reduction (p<0.001) benefits were statistically significant through hospital discharge.

"Overall, the Oxygent-treated patients required 150 fewer units of blood than the control patients, which is a meaningful savings," Spahn reported. "The use of other blood products such as platelets, frozen fresh plasma, and clotting factors was similar for the control and treated patients."

"The safety assessments indicated that Oxygent was well tolerated by the patients," Dr. Spahn stated. The study was completed under the review of an independent Data Safety Monitoring Board.

Patients enrolled in the study were undergoing orthopedic, urologic, abdominal, vascular, and other major surgical procedures, many due to malignant disease, at 34 medical centers in eight European countries. Demographically, the control and treatment patients were well matched, with similar hemoglobin values at study entry and discharge. Oxygent was administered according to Alliance's patented Augmented-Acute Normovolemic Hemodilution(TM) (Augmented-ANH) technique. Blood usage, which consisted of either allogeneic (donor) blood or stored blood that was predonated by the patient during the weeks prior to surgery, was compared for patients who received Oxygent in conjunction with the Augmented-ANH technique vs. standard transfusion therapy.

"As demonstrated in this Phase 3 study, the blood savings provided by Oxygent has the potential to benefit both the individual patient and the local blood supply," said Duane J. Roth, Chairman and CEO of Alliance. For the patient, avoidance of blood is important because transfusions will never be risk-free. Some risks, such as administrative errors and deterioration of blood during storage, affect both predonated and allogeneic blood. While extensive screening of donors and donated blood and blood treatment processes have reduced the risk of viral infection, such measures add incremental costs to the procurement and handling of blood.

"Immunologic risks associated with blood transfusions have become more apparent in recent years, and include active immune reactions to transfused components and immunosuppression," Roth stated. "Blood transfusion has also been linked to cancer recurrence and decreased long-term survival, as well as increased post-operative infection. A large number of the patients enrolled in our Phase 3 study were undergoing cancer-related surgeries, and avoidance of donor blood may be particularly important for them," Roth noted.

"For society," Dr. Spahn commented, "Oxygent and the Augmented-ANH technique may be a valuable means to alleviate the regional blood shortages being experienced throughout the world. Extrapolating from the study data, for every thousand patients undergoing moderate to high blood loss surgery, a savings of 600 units of blood could be achieved with Oxygent treatment."

"Since approximately 8 to 10 million surgeries are performed worldwide each year during which the patient requires transfusions of donor blood, Oxygent usage could result in a significant savings for the blood supply," Roth concluded. "Oxygent could provide a cost-effective alternative that also has the advantages of being a sterilized product that is simple to manufacture in large quantities, does not require blood typing, and can be stored for approximately two years, versus about six weeks for blood."

The Alliance and Baxter agreement regarding Oxygent was established in May 2000. Under the agreement, Baxter obtained an exclusive license for the sales and distribution of Oxygent in the United States, Canada, and Europe, with an option to manufacture the product. The companies are working together to prepare a comprehensive international strategy for seeking regulatory approvals for Oxygent.

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. Imavist(TM), an ultrasound contrast agent being developed with Schering AG, Germany, was the subject of a New Drug Application that has been reviewed by the FDA and found it to be approvable, upon satisfactory response to certain issues identified in the review process. Patient enrollment in an international Phase 2-3 study was completed in December 2000 with LiquiVent(R), an intrapulmonary "liquid ventilation" agent for treatment of acute lung injury and acute respiratory distress syndrome. 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.