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REPEAT/Alliance Pharmaceutical Corp. Announces Oxygent Reduced the Need for Donor Blood in Phase 3 Clinical Study
SAN DIEGO--(BW HealthWire)--Sept. 11, 2000--Alliance Pharmaceutical Corp. announced today that its initial analysis of the data from a Phase 3 study conducted in Europe with Oxygent(TM) (perflubron emulsion), an intravenous oxygen carrier, demonstrated that the product provided a statistically significant reduction in the need for donor blood in the total study population of 492 patients undergoing a variety of general surgery procedures. In addition, a greater percentage of patients in the Oxygent-treated group were able to avoid the need for any donor blood transfusion as compared to the control group. These results will be used to support a planned submission for regulatory approval to market the product in Europe. Oxygent is being developed in the United States, Canada, and Europe in conjunction with Baxter Healthcare Corporation.
The Phase 3 study enrolled patients who were undergoing orthopedic, urologic, abdominal, vascular, and other general surgery procedures at 33 medical centers in eight European countries. Oxygent was administered to the patients according to Alliance's patented Augmented-Acute Normovolemic Hemodilution(TM) (Augmented-ANH) technique. The intent of the study was to determine whether the use of Oxygent and the Augmented-ANH technique would reduce the need for donor blood when compared to standard transfusion therapy. The analysis of efficacy data from the entire study population showed that the patients who received Oxygent during surgery required a statistically significant (p=0.01) fewer number of units of donor blood. In addition, evaluation of the data for the entire study population indicated a trend toward greater avoidance of donor blood transfusions in the Oxygent group as compared to the control group (p=0.06).
The study protocol was specifically designed to analyze the data from those patients for whom a transfusion is most likely to be needed, i.e., patients who actually experienced moderate to high blood loss (1.5 liter or more). The data were even more compelling for this target population, which included two-thirds of all patients enrolled in the study. Oxygent provided a highly statistically significant (p-value less than 0.001) advantage compared to the control group for both the primary and secondary study endpoints of reduction and avoidance of donor blood, respectively. Additional information from the study will be presented at a scientific conference later this year, with a full detailed presentation by the principal investigator to be given at the European Society of Anesthesiology meeting next spring.
With regards to safety, a Data Safety Monitoring Board (DSMB) composed of five international experts reviewed data from more than 80% of the patients at four meetings during the course of the study. At each meeting, the DSMB recommended that the study should be continued without any modification of the protocol. Alliance is currently preparing the data for a final review by the DSMB. Alliance's own analysis of the safety data to date has not revealed anything that would limit the use of Oxygent.
In addition to this Phase 3 general surgery study, Oxygent is being evaluated in a Phase 3 study with cardiac surgery patients undergoing coronary artery bypass grafting (CABG) procedures with cardiopulmonary bypass (CPB) support. This study will enroll 600 patients, primarily at medical centers in the U.S., with additional participation by hospitals in Canada and Europe. Patient enrollment is expected to be completed in the first quarter of 2001.
``We are very pleased with the outcome of the European general surgery study. The results confirm the potential for Oxygent and Augmented-ANH to be an important new therapy for surgical patients,'' said Duane J. Roth, chairman and CEO of Alliance. ``Oxygent is the only oxygen carrier in development that has demonstrated a statistically significant reduction in the use of donor blood in a Phase 3 general surgery study. Alliance and Baxter will work with the European regulatory authorities to determine the most appropriate strategy for submission of a Marketing Authorization Application to the European Medicines Evaluation Agency.''
``There are approximately 8 to 10 million surgeries performed worldwide each year during which the patient requires transfusions of donor blood,'' Roth noted. ``Oxygent may prove to be a cost-effective alternative to donor blood that could help alleviate blood shortages being experienced throughout the world. We are looking forward to completing the cardiac surgery study and forming plans for requesting marketing approval in Europe and the U.S.''
The Alliance and Baxter Healthcare Corporation agreement regarding Oxygent was established in May 2000. Baxter obtained an exclusive license for the manufacture, sales, and distribution of Oxygent in the United States, Canada, and Europe, and has the rights to co-develop Oxygent for further indications. Baxter's initial investment will help support Alliance in the completion of late-stage clinical trials and achievement of regulatory approvals.
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