Printer Friendly
The Free Library
19,585,946 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Alliance Pharmaceutical Corp. Announces Plans for Oxygent Clinical Development in Europe.


Business Editors and Health/Medical Writers

BIOWIRE2K

SAN DIEGO--(BW HealthWire)--March 26, 2002

Alliance Pharmaceutical Corp. (Nasdaq:ALLP ALLP Aldo Leopold Leadership Program )(Nasdaq:ALLPD) announced today 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. 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. 333-72844). 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.
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Mar 26, 2002
Words:625
Previous Article:Loudcloud Listed By Prestigious Analyst Firm as a 'Visionary' In Web Hosting Magic Quadrant Report.
Next Article:NDS Appoints Former Scientific Atlanta Senior Executive as NDS Vice President Corporate Sales.
Topics:



Related Articles
Alliance Pharmaceutical Corp. and Baxter Enter Into Agreement for Oxygent.
Alliance Pharmaceutical Corp. Nets $25 Million in Conjunction With Oxygent Agreement With Baxter.
Alliance Pharmaceutical Corp. Announces Completion of Phase 3 Oxygent Study in Europe.
Alliance Pharmaceutical Corp. Announces Oxygent Reduced the Need for Donor Blood in Phase 3 Clinical Study.
REPEAT/Alliance Pharmaceutical Corp. Announces Oxygent Reduced the Need for Donor Blood in Phase 3 Clinical Study.
Alliance Pharmaceutical Corp. Announces Company Update.
Alliance Pharmaceutical Corp. Receives Proceeds of $15,000,000 Through Private Placement of Common Stock.
Alliance Pharmaceutical Corp. Announces Regulatory Submissions for Oxygent and Receipt of Milestone Payment From Baxter.
ALLIANCE PLANS EUROPEAN PHASE 3 STUDY FOR OXYGENT.
GPC BIOTECH GETS U.S. PATENT FOR ANTI-CANCER CELL INHIBITOR.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles