By Mary Welch

Alliance Pharmaceutical Corp. said its European Phase III general surgery trial for Oxygent (perflubron emulsion) is on track, and that it started Phase III trials in the U.S. for cardiac surgery. Oxygent is an intravascular oxygen carrier designed to reduce the use of donor blood transfusion.

"These things are what we expected but there always is a chance that something unexpected could arise," said Ted Roth, Alliance's president and chief operating officer. "What this does is say that investigators looked at about one-third of the patients enrolled in our European trial and saw nothing there that is of concern from a safety issue. Also that the data we used to arrive at the number of patients we would need was correct and we would not have to increase that number. This keeps us on our timetable."

A prospectively designed interim analysis by a data safety monitoring board (DSMB) confirmed that the proposed 480 patients would be sufficient to conduct a European Phase III study in general surgery. The trial, now taking place at 30 centers in eight countries, is expected to complete enrollment by the middle of next year. The study targets noncardiac general surgeries that entail moderate to high blood loss, such as oncologic, urologic, vascular and orthopedic procedures.

In addition, the DSMB found no safety concerns. The board recommended the study proceed without modification.

Also, the San Diego-based firm will start a U.S. Phase III cardiac surgery study with patients undergoing coronary artery bypass grafting procedures with cardiopulmonary bypass support. The study will be conducted in 40 medical centers with about 600 patients. Enrollment should be completed by the end of 2000.

The company expects the U.S. cardiac surgery data will be combined with the European data from noncardiac surgery patients to support a broad label claim for the use of Oxygent to avoid transfusion in patients undergoing various surgical procedures.

Oxygent is an intravascular oxygen carrier (or blood substitute) that carries oxygen to tissues through the bloodstream. A perflubron-based emulsion, Oxygent contains no blood products and doesn't perform clotting or immunologic functions. Perflubron is derived from the same process used to make Teflon. In Phase II trials it was more effective than a unit of fresh blood in reversing transfusion "triggers" - physiological changes that indicate the need for more blood and in delaying the need for a subsequent transfusion. (See BioWorld Today, Nov. 17, 1998, p.1.)

Alliance's stock (NASDAQ:ALLP) closed Thursday at $5.03, up 71.88 cents, or 17 percent.