Alliance Pharmaceutical Corp. Announces LiquiVent Phase 2-3 Clinical Trial Progress.Business Editors and Health/Medical Writers BIOWIRE2K SAN DIEGO--(BW HealthWire)--March 16, 2000 Alliance Pharmaceutical Corp. (Nasdaq:ALLP ALLP Aldo Leopold Leadership Program ) Thursday announced that it has achieved certain key milestones in its Phase 2-3 clinical study with LiquiVent(R), an intrapulmonary agent for treatment of acute lung injury (ALI) and acute respiratory distress syndrome acute respiratory distress syndrome n. See adult respiratory distress syndrome. (ARDS Ards District (pop., 2001: 73,244), Northern Ireland. Formerly part of County Down, Ards was established as a district in 1973. Much of its land is devoted to crops and pasture. Newtownards, settled c. 1608 by Scots, is its administrative seat and manufacturing centre. ). These milestones include a review of safety data from this study by an independent 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 completion of a planned interim analysis to optimize the number of patients to be enrolled in the study. LiquiVent is an oxygen-carrying liquid drug (perflubron) being developed under 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. ) "fast track" regulations. LiquiVent is administered via Alliance's proprietary Partial Liquid Ventilation(TM) technique directly into the lungs of a patient who is being supported by a mechanical ventilator. The goal of LiquiVent therapy is to protect the lungs by reducing the patient's exposure to the harmful effects of conventional mechanical ventilation mechanical ventilation n. A mode of assisted or controlled ventilation using mechanical devices that cycle automatically to generate airway pressure. , while facilitating the exchange of respiratory gases and promoting removal of debris from the lungs. LiquiVent is therefore expected to minimize the potential for ventilator-induced lung injury ventilator-induced lung injury Volutrauma Those changes related to ventilatory support of Pts with acute respiratory failure and/or ARDS, which may exacerbate already compromised pulmonary function Management Permissive hypercapnia, see there and to reduce the number of days that the patient requires ventilation support. The Phase 2-3 pivotal trial is a 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. , controlled study being conducted in North America and Europe to evaluate the safety and efficacy of LiquiVent for adult ALI and ARDS patients. The DSMB, a group of leading clinicians with expertise in critical care medicine, periodically reviews safety data from the study. Following the recent completion of its review of data from more than 165 patients, the DSMB notified Alliance that it had no safety concerns, and recommended that the study should continue as planned. Separate from the DSMB review, a prospectively designed interim analysis was performed on blinded data for the purpose of assuring statistical power for the study endpoint of "ventilator-free days." As a result of this analysis, the study will be adjusted slightly to include approximately 15 additional patients for each of the three study arms. "We are pleased with the DSMB safety review and the interim analysis, which reflect favorably on the trial design and conduct," said Duane J. Roth, Alliance 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. . "Even with the minor adjustment in the number of patients, we have completed approximately two-thirds of the enrollment for the study. At the current enrollment rates, we expect to complete enrollment for the entire study during the third quarter of the year," he added. 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. In addition to LiquiVent, the company is developing Oxygent(TM), 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 ("blood substitute") being evaluated in Phase 3 clinical studies in the U.S. and Europe to reduce the need for donor blood during surgery. Alliance has filed a New Drug Application with the FDA for approval of Imagent(R), an ultrasound contrast agent being developed in partnership with Schering AG, Germany. 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 readers 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. 333-76343). For further information, contact Gwen Rosenberg, Vice President, Corporate Communications, at 858/410-5275. |
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