ALLIANCE PLANS EUROPEAN PHASE 3 STUDY FOR OXYGENT.Alliance Pharmaceutical Corp. (Nasdaq:ALLP ALLP Aldo Leopold Leadership Program )(Nasdaq:ALLPD), San Diego, has announced that representatives from Alliance and Baxter Healthcare Corp. have met with selected European regulatory authorities to review the clinical development plans for Oxygent(TM) (perflubron emulsion), an intravascular intravascular /in·tra·vas·cu·lar/ (in?trah-vas´ku-lar) within a vessel. in·tra·vas·cu·lar adj. Within one or more blood vessels. oxygen carrier intended to avoid the need for donor blood in elective surgery elective surgery Surgery Any operation that can be performed with advanced planning–eg, cholecystectomy, hernia repair, colonic resection, coronary artery bypass . Based on positive interactions at these meetings, the companies are now planning a pivotal European Phase 3 study involving general surgery patients undergoing various procedures. Oxygent is being developed by Alliance in the United States, Canada, and Europe in conjunction with Baxter. The proposed study protocol was developed utilizing data from a successful international Phase 3 study with 492 surgical patients, which demonstrated that Oxygent and acute normovolemic hemodilution treatment provided a statistically significant reduction and avoidance of donor blood usage. The new pivotal study would focus on the use of Oxygent for patients undergoing various general surgery procedures that are expected to result in moderate blood loss that usually requires transfusion of donor blood. Patients will be randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. at the time a blood transfusion blood transfusion, transfer of blood from one person to another, or from one animal to another of the same species. Transfusions are performed to replace a substantial loss of blood and as supportive treatment in certain diseases and blood disorders. is deemed necessary according to a defined transfusion trigger transfusion trigger Transfusion threshold Transfusion medicine The Hct and Hb values at or below which packed red cells are usually ordered for transfusion by a clinician; the most widely used current TT is a Hb of 70 g/L, after an NIH consensus = conference; lower . The acute normovolemic hemodilution technique will not be used in this study; instead, treatment patients will receive Oxygent, while control patients will receive blood. The primary endpoint of the study will be the avoidance of donor blood transfusions. "We are looking forward to completing the development of Oxygent in Europe," said Duane J. Roth, chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Alliance. "The results from the previous general surgery study were extremely helpful in enabling us to design a protocol in which Oxygent is used in the same manner as blood, and is administered when the patient needs a transfusion during the surgical procedure." As announced previously, the companies also intend to resume clinical development of Oxygent in the U.S. Active discussions are currently ongoing with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) regarding the information package submitted to the agency in January. Details about the development plan for Oxygent in the U.S. will be finalized and communicated after the appropriate FDA discussions have been completed. 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 two 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 Surfactant Definition Surfactant is a complex naturally occurring substance made of six lipids (fats) and four proteins that is produced in the lungs. It can also be manufactured synthetically. 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 awaiting final FDA approval, is being developed jointly by Alliance and Schering AG, Germany, and will be marketed in the U.S. in partnership with Cardinal Health Inc. For more information, visit http://www.allp.com or 858/410-5275. |
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