Oxygent

	Blood Substitutes
Links Introduction History of Blood Substitutes Hemopure^® Oxyglobin^® PolyHeme^® Hemospan^® Dextran-Hemoglobin Oxygent^® Emerging Ideas - Dendritech^® Does the Future Rest on Stem Cells? - Interview with Dr. Narla Credits	Oxygent^TM Oxygent is a solution used as an intravascular oxygen carrier to temporarily augment oxygen delivery to tissues and is currently being developed by Alliance Pharmaceutical Corp. Right now, the goal of the development of Oxygent is simply to reduce the need for donor blood during surgery, but this product clearly has the potential for additional future uses. Perfluorocarbons surrounded by a surfactant called lecithin and suspended in a water based solution give Oxygent its oxygen carrying capacity. The Oxygent particles are removed from the bloodstream within 48 hours by the body's normal clearance procedure for particles in the blood. Namely, the lecithin is digested intracellularly and the PFC's are exhaled through the lungs. Advantages Oxygent is entirely manmade, containing no human or animal blood or blood components. This gives Oxygent a number of advantages over its HBOC competitors: HBOC’s rely on human or animal hemoglobin which limits their manufacturing capacity. Oxygent has no such check and has a production capacity of 10 times that of its closest competitor. Oxygent cannot transmit viruses or other infectious agents, and it is able to be heat-sterilized to prevent bacterial infection without any harm coming to the solution. The oxygen-carrying particles in Oxygent are roughly 1/40 the size of red blood cells giving them the ability to get around blockages in blood vessels that would hinder or stop the bulky erythrocytes. The small size also makes perfluorocarbons more efficient oxygen carriers than hemoglobin, with one unit of Oxygent having the equivalent oxygen carrying capacity of 1-2 units of red blood cells. Oxygent shares some advantages over donor blood with its HBOC competitors as well: Oxygent is universally compatible. Oxygent has a shelf life of 2 years compared to 42 days for donor blood. Oxygent does not need to be refrigerated. Clinical Trials Alliance Corp. has completed 18 clinical studies including Phase I safety studies, Phase II general surgery studies, Phase II cardiac surgery studies, and a Phase III general surgery study. The Phase II studies showed that Oxygent was significantly more effective than a unit of blood in delaying the need for a subsequent blood transfusion. The Phase III study, which was performed in Europe on 429 patients undergoing a variety of surgical procedures, demonstrated that Oxygent reduced the need for donor blood, and in some cases eliminated it compared to the control group. These clinical data all indicate that Oxygent is safe at clinically relevant doses. Alliance Corp. has run into some problems, however. In 2003, they suspended a new Phase III trial done with cardiac surgery patients when it was discovered that they were slightly more likely to suffer a stroke than the control group. While this does not mean definitively that the product is unsafe, the results did raise some eyebrows. Nevertheless, the corporation expects to initiate a new Phase III shortly.

Oxygent^TM

Oxygent is a solution used as an intravascular oxygen carrier to temporarily augment oxygen delivery to tissues and is currently being developed by Alliance Pharmaceutical Corp. Right now, the goal of the development of Oxygent is simply to reduce the need for donor blood during surgery, but this product clearly has the potential for additional future uses. Perfluorocarbons surrounded by a surfactant called lecithin and suspended in a water based solution give Oxygent its oxygen carrying capacity. The Oxygent particles are removed from the bloodstream within 48 hours by the body's normal clearance procedure for particles in the blood. Namely, the lecithin is digested intracellularly and the PFC's are exhaled through the lungs.

Advantages

Oxygent is entirely manmade, containing no human or animal blood or blood components. This gives Oxygent a number of advantages over its HBOC competitors:

HBOC’s rely on human or animal hemoglobin which limits their manufacturing capacity. Oxygent has no such check and has a production capacity of 10 times that of its closest competitor.

Oxygent cannot transmit viruses or other infectious agents, and it is able to be heat-sterilized to prevent bacterial infection without any harm coming to the solution.

The oxygen-carrying particles in Oxygent are roughly 1/40 the size of red blood cells giving them the ability to get around blockages in blood vessels that would hinder or stop the bulky erythrocytes.

The small size also makes perfluorocarbons more efficient oxygen carriers than hemoglobin, with one unit of Oxygent having the equivalent oxygen carrying capacity of 1-2 units of red blood cells.

Oxygent shares some advantages over donor blood with its HBOC competitors as well:

Oxygent is universally compatible.

Oxygent has a shelf life of 2 years compared to 42 days for donor blood.

Oxygent does not need to be refrigerated.

Clinical Trials

Alliance Corp. has completed 18 clinical studies including Phase I safety studies, Phase II general surgery studies, Phase II cardiac surgery studies, and a Phase III general surgery study. The Phase II studies showed that Oxygent was significantly more effective than a unit of blood in delaying the need for a subsequent blood transfusion. The Phase III study, which was performed in Europe on 429 patients undergoing a variety of surgical procedures, demonstrated that Oxygent reduced the need for donor blood, and in some cases eliminated it compared to the control group. These clinical data all indicate that Oxygent is safe at clinically relevant doses.

Alliance Corp. has run into some problems, however. In 2003, they suspended a new Phase III trial done with cardiac surgery patients when it was discovered that they were slightly more likely to suffer a stroke than the control group. While this does not mean definitively that the product is unsafe, the results did raise some eyebrows. Nevertheless, the corporation expects to initiate a new Phase III shortly.