By Sheila Dwyer, Body1 Staff
Over the past 25 years, there has been a race to create a viable human blood substitute. Since the 1990s, several high-tech healthcare companies have developed and tested their products in the United States and Europe. Despite their massive efforts, the Federal Drug Administration (FDA) has not approved any of them for use yet in the United States. Recently, Alliance Pharmaceutical Corporation of San Diego tested its product, Oxygent, on non-trauma patients with promising results.
Blood substitutes are desirable and necessary for several reasons. First, despite excellent screening methods, donated blood cannot be considered 100 percent safe. There is still a small chance of transmitting a virus such as Hepatitis C or HIV through transfusion. Second, donated blood is increasingly scarce. U.S. health officials report that blood supply is chronically low, with a potential shortage of 250,000 units this year alone. This shortage puts potential recipients at risk, especially when doctors must take further steps to match a patient’s blood type to the blood available. Third, the military and civilian organizations are interested in obtaining a blood substitute that has a longer shelf life than whole-blood, which is only good for about 42 days. The military would like to have stockpiled blood on hand that could be used immediately in a battlefield situation. In a normal hospital setting, elective surgeries would not have to be cancelled or postponed due to blood shortage, as some are now.
Alliance is currently testing a product that promises to alleviate the demand for donated blood. Oxygent is a milky white, synthetic substance made from easy-to-manufacture fluorocarbons. One of the greatest benefits of Oxygent is its efficient distribution of oxygen to the body; it delivers twice as much oxygen twice as fast as an equal amount of blood’s hemoglobin. Alliance completed Phase III of their Oxygent study in Europe in May of this year.
Baxter Healthcare, another pharmaceutical outfit, tested a product called HemAssist in the late 1990s. The goal of HemAssist was the same as that of Oxygent, but the make-up of the substances was different. HemAssist was not synthetic; instead, it was a hemoglobin-based substitute that was produced from donated blood. Scientists manipulated human hemoglobin to stay fresh longer, which would have eliminated the need to utilize a fresh blood donation within 42 days.
In 1998, Baxter voluntarily halted their clinical trial when trauma patients died at a higher rate than expected. In a departure from industry tradition, the company has allowed others to learn from their failures. Baxter is currently developing another hemoglobin-based blood substitute, but it is far from ready for human testing. It will probably take several years to appear on the market.
Learning from Baxter’s trial has helped Alliance with their own trial. Oxygent is now administered in a surgical setting rather than in an emergency room; the chaos of the emergency room setting contributed to some of HemAssist’s failures.
In May of 2000, Alliance announced that it received $20 million from Baxter Healthcare. This money will be used toward the manufacturing, sales, and distribution of Oxygent in the United States, Canada, and Europe. In addition, Baxter will support Alliance’s late-stage clinical trials and pursuit of regulatory approvals. In the event of FDA approval, Baxter will have a license to manufacture, sell, and distribute Oxygent and will have the rights to co-develop it for further study.
Phase III of the Alliance trials have given the industry reason to believe that a blood substitute could be on the market within a few years. For patients awaiting life-saving blood, this is encouraging news.
For more information visit Alliance Pharmaceutical Corporation's Web site.