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Alliance Pharmaceutical Corp. Announces Preliminary Results of LiquiVent Phase 2-3 Clinical Study.


Business Editors & Health/Medical Writers

BIOWIRE2K

SAN DIEGO--(BW HealthWire)--May 21, 2001

Alliance Pharmaceutical Corp. (Nasdaq:ALLP ALLP Aldo Leopold Leadership Program ) announced today preliminary results from a Phase 2-3 clinical study that evaluated the use of Partial Liquid Ventilation(TM) (PLV PLV Plaatsvervangend
PLV Publicité sur le Lieu de Vente (POS advertising, promotions)
PLV Production Level Video
PLV Payload Launch Vehicle
PLV Posterior Left Ventricle
PLV Pulsed Light Velocimetry
PLV Platoon Leader Vehicle
) with LiquiVent(R) for adult patients with 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.
) being supported by a mechanical ventilator.

Efficacy data from the study revealed that PLV with LiquiVent did not meet either the primary study endpoint for improvement in "ventilator free days" or the secondary endpoint of improvement in 28-day mortality. Safety data demonstrated that LiquiVent, an oxygen-carrying liquid (perflubron), was well tolerated by the patients.

"While we are disappointed with the results of the study and we do not contemplate further PLV studies with adult ARDS patients, Alliance intends to pursue the use of LiquiVent for other indications in the treatment of lung disease lung disease Pulmonary disease Pulmonology Any condition causing or indicating impaired lung function Types of LD Obstructive lung disease–↓ in air flow caused by a narrowing or blockage of airways–eg, asthma, emphysema, chronic bronchitis; ," 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. "Alliance's immediate focus will remain our previously stated priorities, which are 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.
 approval for our Imavist(TM) ultrasound contrast agent and the resumption of clinical development of Oxygent(TM), both of which are expected later this year."

"Mortality in adult ARDS patients was widely accepted at 40 percent or more when this clinical trial was initiated," said Mark Wedel we·del  
intr.v. we·deled, we·del·ling, we·dels
To ski on snow by means of wedeln.



[Back-formation from wedeln.]

Verb 1.
, MD, JD, FACP FACP Fellow of the American College of Physicians.

FACP
abbr.
1. Fellow of the American College of Physicians

2. Fellow of the American College of Prosthodontists
, the LiquiVent program director. "Since then, however, a large study sponsored by the National Institutes of Health has demonstrated a major improvement in mortality by utilizing a 'lung protective strategy' in mechanical ventilation mechanical ventilation
n.
A mode of assisted or controlled ventilation using mechanical devices that cycle automatically to generate airway pressure.
. Our Phase 2-3 study protocol also utilized lung protective ventilation, and we were optimistic that LiquiVent would provide additional clinical benefit beyond this new strategy. Although PLV with LiquiVent achieved an impressive 19 percent mortality, this was not significantly different than the control group mortality of 15 percent. The results of our trial have confirmed that lung protective ventilation can dramatically reduce lung injury. The trial results also suggest that partial liquid ventilation does not provide incremental benefit when compared to these new ventilation strategies.

"During the course of evaluating LiquiVent in pre-clinical and clinical studies, a great deal of knowledge has been gained regarding the use of perflubron for treatment of various types of lung injury and as a safe vehicle for drug delivery," Dr. Wedel noted.

"We now intend to focus on less invasive methods of using LiquiVent, especially treatments that use small or nebulized doses of the product to address the needs of the large number of less severely ill respiratory patients. We will inform the public about our new development plans for LiquiVent in the coming months," Wedel stated.

Dr. Herbert Wiedemann, Professor and Chairman of Pulmonary and Critical Care Medicine at the Cleveland Clinic Foundation, presented the Phase 2-3 preliminary results today at a meeting attended by LiquiVent investigators in San Francisco. "The study enrolled 311 adult patients at 56 medical centers in the U.S., Europe, and Canada. It was a well designed and well conducted clinical trial in a very difficult patient population," Dr. Wiedemann noted.

"Despite the trial result, I am hopeful that LiquiVent will continue to be investigated for other applications in the treatment of lung diseases," Dr. Wiedemann concluded. "Such applications might include use of LiquiVent for delivery of therapeutic agents such as antibiotics or genes directly into the lungs, or its use as a lung recruiting, anti-inflammatory, or lavage lavage /la·vage/ (lah-vahzh´)
1. the irrigation or washing out of an organ, as of the stomach or bowel.

2. to wash out, or irrigate.


lav·age
n.
 (lung washing) agent."

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. Alliance is developing Oxygent, 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 in Phase 3 development, in the United States, Canada, and Europe in conjunction with Baxter Healthcare Corporation. Imavist, an ultrasound contrast agent being developed with Schering AG, Germany, was the subject of a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) submitted to the Food and Drug Administration (FDA) in October 1999. In August 2000, Alliance announced that the FDA had completed its review of the NDA for Imavist and found it to be approvable, upon satisfactory response to certain issues identified in the review process. 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 and Form 10-Q, and those risk factors set forth in the most recent registration statement on Form S-3 (File No. 333-47032) and Form S-4 (File No. 333-49676). Alliance is under no obligation (and expressly disclaims any obligation) to update or alter its forward-looking statements, whether as a result of new information, future events, or otherwise.
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Publication:Business Wire
Geographic Code:1USA
Date:May 21, 2001
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