Alliance Pharmaceutical Corp. Announces Oxygent Phase 3 Clinical Trials Progress.SAN DIEGO--(BW HealthWire)--Dec. 1, 1999-- Alliance Pharmaceutical Corp. (Nasdaq:ALLP ALLP Aldo Leopold Leadership Program ) announced today that it has achieved certain key milestones in its two Phase 3 clinical (human) studies for Oxygent(TM) (perflubron emulsion). These milestones include a prospectively designed interim analysis to confirm the number of patients required in the European Phase 3 general surgery trial, a review of safety data from this study by the Data Safety Monitoring Board (DSMB DSMB Data & Safety Monitoring Board Clinical research A committee of independent clinical research experts who review data in ongoing clinical trials, ensuring that participants are not exposed to undue risk, and look for any differences in effectiveness ), and the initiation of the U.S. Phase 3 cardiac surgery study. Oxygent is 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 (temporary "blood substitute") intended to reduce the need for donor blood transfusions in surgical patients when used according to Alliance's proprietary Augmented Acute Normovolemic Hemodilution (A-ANH(TM)) method. The goal of this Phase 3 program is to establish the safety and effectiveness of Oxygent in both general and cardiac surgery patients. The European trial targets general surgery patients undergoing moderate to high blood loss noncardiac (e.g., oncologic, urologic, vascular, and orthopedic) procedures. It is being conducted at 30 centers in 8 European countries and will enroll approximately 480 patients. The recently completed interim analysis, performed on blinded data, was designed solely for the purpose of verifying the number of patients needed to achieve the study endpoint. The results indicated that the projected number of patients does not need to be increased. Accordingly, the trial is expected to complete enrollment by the middle of next year. The DSMB for this study is an independent group of experts that include a biostatistician and leading European clinicians with specific expertise in anesthesiology, critical care, transfusion medicine transfusion medicine Blood banking A subspecialty of clinical pathology or internal medicine which is involved in Pt management through administration of blood cells and blood products including fresh-frozen plasma and cryoprecipitate; TM specialists are versant in , and surgery. The primary role of the DSMB is to periodically review the safety data from the study. This review is conducted independently from Alliance and the participating clinical investigators. After a recent review of safety data from approximately one-third of the patients expected to be enrolled in the study, the DSMB indicated that they had no safety concerns and recommended that the study should proceed without modification. "We are pleased with the results of the interim analysis and the DSMB findings and look forward to continued progress in this Phase 3 study," said Duane Roth, Chairman & 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 U.S. Phase 3 study targets cardiac surgery patients undergoing coronary artery bypass grafting (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. This study is being conducted in 40 medical centers and will enroll approximately 600 patients. Upon successful completion of the U.S. study, Alliance anticipates that the cardiac surgery data will be combined with the European data from noncardiac surgery patients to support a broad label claim for the use of Oxygent to avoid transfusion in patients undergoing various surgical procedures. Oxygent which is formulated from a synthetic drug substance, is the only "blood substitute" in clinical development that is not derived from either human or animal blood. Alliance Pharmaceutical Corp. is a research and development company with three products in late-stage clinical development, each addressing a different medical need. In addition to Oxygent, LiquiVent(R) an intrapulmonary "liquid ventilation" agent, is in a pivotal Phase 2-3 study 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. . Imagent, an ultrasound contrast agent being developed with Schering AG, Germany, is the subject of a New Drug Application recently submitted to the U.S. Food and Drug Administration. 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. 333-76343). |
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