By Brady Huggett
Alliance Pharmaceutical Corp., of San Diego, said initial data analysis of the Phase III European study of Oxygent showed a statistically significant reduction in the need for donor blood in surgery patients. While conjunctive studies are ongoing, these initial results suggest a day when surgery patients, hospitals and the Red Cross may breathe easier.
"We were looking for a reduction in the use of donor blood and what we found was a highly statistically significant reduction in blood usage," said Gwen Rosenberg, vice president of corporate communications of Alliance.
The study was designed to test the use of Oxygent against standard transfusion therapy. The efficacy data showed the entire population of patients receiving Oxygent during surgery needed fewer units of blood (on the average, one unit less, with a statistical significance of p=0.01). The data also showed the target group in the study - patients requiring 1.5 liters of blood or more - averaged two units less blood needed (p<0.001).
Oxygent is an intravenous oxygen carrier - a sterile emulsion the color of milk - that is comprised of liquid perfluorochemical (PFC) core particles surrounded by a surfactant and suspended in a water-based solution. The synthetic PFC particles have the ability to dissolve and transport oxygen, carbon dioxide, and other gases. Oxygent is fed into the patient's bloodstream and acts as blood would: picking up oxygen in the lungs and delivering it to tissues, then pulling carbon dioxide from the tissues and toting it back to the lungs for exhalation. The body cleans Oxygent from the blood itself, breaking down the surfactant and expelling the PFC through the lungs within 48 hours.
Rosenberg said the results of the general surgery trial will be used to support a market authorization application in Europe. A second Phase III trial, centered in the United States, but with tendrils in Canada and Europe, should complete enrollment of 600 cardiac surgery patients in the first quarter of 2001.
If results of the second Phase III trial are positive, U.S. New Drug Application would seek approval based on data from both the cardiac and general surgery studies under a general label. In Europe, the cardiac data will also be used to submit a cardiac surgery application.
Oxygent should be cost-effective in that it will reduce the need for donor blood, said Rosenberg, adding that Oxygent is the first blood substitute that is a synthetic-based product.
"Oxygent does not use any human or animal blood components," she said. "This is beneficial because we don't have to worry about raw material supplies." Also, because Oxygent is completely synthetic, it can be sterilized, and thus carries no risk of bacteria or blood-borne pathogens for the patients, said Rosenberg.
"This can be quite a huge product because the market for donor blood is a $1.5 billion market," said Fariba Ghodsian, an analyst with Roth Captial Partners, in Newport Beach, Calif. She noted that Alliance's product is "very differentiated" from competitors.
Alliance signed a $50 million deal for Oxygent with Baxter Healthcare Corp. in May, giving Baxter exclusive license for the manufacture, sales and distribution of Oxygent in the United States, Canada and Europe. Baxter also has the rights to co-develop Oxygent for further indications. (See BioWorld Today, May 15, 2000, p. 1.)
With eight to 10 million patients requiring two or more units of blood worldwide annually, Oxygent has a wide market, said Rosenberg. Alliance hopes to have Oxygent in hospitals by 2002.
"I think many investors look at Oxygent as our flagship product," said Rosenberg. "If results continue as they are, we feel this will be very beneficial to the company."
Alliance submitted an NDA for Imavist in October 1999, and in August the FDA completed its review, saying it would approve the application upon receiving responses to certain issues brought up in the review process.
Alliance shares jumped 10.7 percent to $16.88 Monday following the release of the Phase III news. The company had earlier reported positive interim data for Oxygent. (See BioWorld Today, Dec. 3, 1999, p. 1.)