I just ran by this post on the Fool thread. Does anyone know if this is realy as good as NFLDs product?
ALLIANCE PHARMACEUTICAL CORP. ANNOUNCES OXYGENT ENHANCES OXYGENATION MORE EFFECTIVELY THAN BLOOD IN PHASE II TRIALS
San Diego, California, September 8, 1997--- Alliance Pharmaceutical Corp (NASDAQ-ALLP) announced today that Peter E. Keipert, Ph.D, presented a summary of two Phase II surgical trials which demonstrated that Oxygent (perflubron emulsion), a temporary oxygen carrier, enhanced oxygenation status and reversed transfusion triggers more frequently and for a longer duration than fresh blood. In the presentation at the International Symposium on
Blood Substitutes in Tokyo, Japan, Dr. Keipert noted that Oxygent is being co-developed worldwide by Alliance in conjunction with the R. W. Johnson Pharmaceutical Research Institute and Ortho Biotech, Inc. both Johnson & Johnson companies.
The completed Phase II trials, which were conduted by the R.W. Johnson Pharmaceutical Research Institute, involved a total of 256 surgical patients. The primary purpose of the studies was to compare the ability of Oxygent versus blood to reverse transfusion triggers, which are physiologic indications of when a patient requires a transfusion, and to maintain the effect of the reversal by providing systemic oxygenation.
Dr. Keipert reported that data from the two studies demonstrated Oxygent was significantly more effective than blood in reversing transfusion triggers. In addition, Oxygent delayed the need for a subsequent blood transfusion significantly longer than blood. Oxygent was well-tolerated by patients in both studies.
"We are very pleased that these studies have suppported the efficacy of Oxygent compared to blood," said Duane Roth, President and CEO of Alliance. "The results of these studies provide us with the essential datat needed to implement future studies to confirm Oxygent's utility as a safe and effective product for the delivery of oxygen."
The randomized, single-blind Phase II studies, which were conducted at more than 20 medical centers in the U.S. and Europe, involved patients who were undergoing orthopedic, gynecologic, or urologic elective surgery procedures that typically result in moderate to high blood loss. All patients were hemodiluted prior to surgery, a procedure involving removal of a portion of the patient's blood, which is replaced with a volume expander. As
the surgery progressed, the patient's blood loss, oxygenation status, and physiologic functions were monitored. When the patient reached a first transfusion trigger, either Oxygent plus 100% oxygen, a unit of fresh autologous blood that had been collected during the hemodilution procedure, or a volume expander plus 100% oxygen was administered. The transfusion trigger was noted.
Further data from the studies are being submitted for presentation by the principal investigators at the March 1998 meeting of the International Anaesthesia meeting in Barcelona, Spain. Additional Phase II studies in which Oxygent is administered to patients undergoing cardiopulmonary bypass (CPB) procedures are nearing completion.
Oxygent is being developed by Alliance in conjunction with the R. W. Johnson Pharmaceutical Research Institute and Ortho Biotech, Inc. both Johnson & Johnson companies, as an intravascular oxygen delivery system for use in patients at risk of acute tissue oxygen deficit. The product is a peflubron-based emulsion that can be universally administered to patients of all blood types. Oxygent does not contain blood or blood products, it can be
produced in large quantities using a proprietary manufacturing process, and it can be stored for up to two years. Oxygent is a sterile product and cannot transmit viruses such as those responsible for AIDS and hepatitis. To date, Oxgent has been evaluated in clinical studies involving more thatn 500 patients, including extensive safety studies in healthy volunteers and surgical patients.
Alliance is a pharmaceutical research and development company focusing on transforming novel scientific discoveries into innovative drug products. In addition to Oxygent, it has two other products based on its perfluorochemical technologies currently in development; LiquiVent (neat perflubron), an intrapulmonary agent to reduce a patien's exposure to the harmful effects of conventional mechanical ventilation, which is being co-developed
with Hoechst Marion Roussel; and Imagent US, an intravenous contrast agent for enhancement of ultrasound images to assess cardiac function and detect blood flow abnormalities (perfusion defects). On July 21, 1997, Alliance announced an agreement in principle with Schering AG, Germany, for the worldwide co-development of Imagent US.
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 uncertainties associated with the conduct of pre-clinical or clinical studies and the timing or ability to investigate scientific data. The Company refers you to caustinary information contained in
documents the Company files with the Securities and Exchange Commission from time to time, including the last Form 10K and Form 10Q, and those risk factors set forth in the recent registration statement on Form S3 (Registration Number 333-06739)
For further information, please contact Gwen Rosenberg, Director of Corporate Communications, at (619) 558-4375
END
Is this product usefull for ER patients? Some pro-Alliance poster must think this is the end for NFLD. |
