Alliance Pharmaceutical Corp. Announces Completion of Phase 3 Oxygent Study in Europe.Business Editors/Health & Medical Writers BIOWIRE2K SAN DIEGO--(BUSINESS WIRE)--May 31, 2000 Alliance Pharmaceutical Corp. (Nasdaq:ALLP ALLP Aldo Leopold Leadership Program ) announced today that enrollment has been completed in a pivotal Phase 3 study with Oxygent(TM) (perflubron emulsion), a chemical-based intravenous oxygen carrier being developed to reduce the need for donor blood transfusions during surgery with a procedure called Augmented-Acute Normovolemic Hemodilution(TM) (Augmented-ANH). The Phase 3 study, which involved 484 surgical patients at 33 medical centers in eight European countries, is the largest clinical trial completed to date with an oxygen carrier for this indication. The Phase 3 study enrolled patients undergoing orthopedic, cancer, urologic, vascular, and other high blood loss, general surgery procedures. Preliminary results are expected to be available this fall after conclusion of the patient follow-up period and data compilation. Results from this study and several previous clinical trials involving more than 1,000 patients are expected to be included in a Marketing Authorization Application (MAA MAA abbr. macroaggregated albumin ) that is being prepared for filing with the European Medicines Evaluation Agency. The MAA will be submitted through a centralized regulatory review process that, when approved, will enable Oxygent to receive a single marketing authorization simultaneously in all European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community countries. The EU represents a substantial market opportunity, with a population greater than that of the U.S. and Canada combined. "Completion of this large, well-controlled study represents a major milestone for Alliance and for oxygen delivery products in general," said Duane Roth, chairman and chief executive officer of Alliance. "We will now proceed with the analyses of the data and look forward to the regulatory submission." The World Health Organization (WHO) recently launched a new initiative ("Safe Blood Starts with Me") to address issues regarding blood safety and an adequate supply. Dr. Marc Danzon, WHO Regional Director for Europe, stated that, "People everywhere have the right to expect that their governments will take all steps necessary to ensure access to an adequate supply of safe blood when and where it is needed, and that their health professionals will be properly trained to use blood only when appropriate and when other alternatives will not answer." Roth commented, "We believe that Oxygent, used with our patented Augmented-ANH technique, can provide an alternative for many patients undergoing elective surgery elective surgery Surgery Any operation that can be performed with advanced planning–eg, cholecystectomy, hernia repair, colonic resection, coronary artery bypass by allowing each patient to become his or her own blood donor." Augmented-ANH involves the collection of several pints of blood from the patient in the operating room operating room n. Abbr. OR A room equipped for performing surgical operations. immediately prior to surgery. Oxygent would then be administered to the patient to replace the oxygen-carrying capacity of the collected blood. When the surgery is completed, the patient's blood that was removed and conserved during surgery would then be re-infused to achieve a safe red cell concentration for postoperative recovery. Augmented-ANH is thus intended to enhance standard hemodilution methods and thereby minimize the need for donor blood transfusions during and after surgery. Augmented-ANH is also being used with Oxygent in a Phase 3 study involving 600 cardiac surgery patients undergoing coronary artery bypass grafting coronary artery bypass graft n. Abbr. CABG A surgical procedure in which a section of vein or other conduit is grafted between the aorta and a coronary artery below the region of an obstruction in that artery. (CABG CABG coronary artery bypass graft. CABG abbr. coronary artery bypass graft CABG Coronary artery bypass graft, see there ) procedures with cardiopulmonary bypass cardiopulmonary bypass n. A procedure to circulate and oxygenate the blood during heart surgery involving the diversion of blood from the heart and lungs through a heart-lung machine and the return of oxygenated blood to the aorta. (CPB CPB see cardiopulmonary bypass. CPB Cardiopulmonary bypass. See Port-Access cardiopulmonary bypass. ) support that is ongoing in the U.S., Canada, and Europe. Oxygent is the only oxygen-carrying therapeutic in Phase 3 whose studies were designed to support a label claim for use in patients undergoing both cardiac and non-cardiac surgical procedures. Alliance and Baxter Healthcare Corp. reached an agreement this month for the manufacturing, sales and distribution of Oxygent in the United States, Canada, and Europe. Baxter's initial investment will help support Alliance in the completion of late-stage clinical trials and achievement of regulatory approvals. Baxter will obtain an exclusive license for the manufacture, sales, and distribution of Oxygent and will have the rights to co-develop Oxygent for further indications. 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. The company's products are intended primarily for use during acute care situations, including surgical, cardiology, and respiratory applications. In addition to Oxygent, Alliance is developing LiquiVent(R), an intrapulmonary "liquid ventilation" agent being evaluated in pivotal Phase 2-3 studies in North America and Europe for treatment of acute lung injury and acute respiratory distress syndrome acute respiratory distress syndrome n. See adult respiratory distress syndrome. . Alliance has filed a New Drug Application 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. ) for approval of Imagent(R), an ultrasound contrast agent being developed in partnership with Schering AG, Germany. 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. and Form 10-Q Form 10-Q See 10-Q. , and those risk factors set forth in the most recent registration statement on Form S-3 (File No. 333-33242). |
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