Alliance Pharmaceutical Corp. began Phase III pivotal trials for two products: LiquiVent (perflubron) to treat acute lung injury and acute respiratory distress syndrome; and Oxygent, a blood substitute to augment oxygen delivery in patients undergoing surgery.
A third product, the ultrasound contrast agent Imagent, entered Phase III trials in March.
LiquiVent, an oxygen-carrying liquid administered directly into the lungs, is designed to protect the lungs by reducing a patient's exposure to the effects of mechanical ventilation.
Oxygent, a perflubron-based emulsion that contains no blood or blood components, has been shown in Phase II trials to be 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.
In May 1997, Johnson & Johnson, of New Brunswick, N.J., returned development rights for Oxygent to Alliance, but did not altogether sever the relationship, said Gwen Rosenberg, spokeswoman for San Diego-based Alliance.
"We restructured the agreement," she said. "Before, they were co-developing [Oxygent]. We took over the clinical development because we thought it would move faster, and it has."
J&J has the right-of-first-offer for worldwide marketing, Rosenberg said.
"We can come back to them when we've demonstrated the product is as valuable as we think it is," she added.
A pediatric Phase III study of LiquiVent for acute respiratory distress syndrome was halted in April of last year so the company could study a control-group anomaly. The study resumed four months later, but Alliance's partner, Hoechst Marion Roussel, of Frankfurt, Germany, pulled out of the collaboration. (See BioWorld Today, April 16, 1997, p. 1.; August 29, 1997, p. 1; and Dec. 9, 1997, p. 1.)
"We've been [evaluating] three different patient populations: neonate, pediatric and adult," Rosenberg said, adding that 85 percent to 90 percent of patients on ventilators are adults.
Alliance is talking with other potential collaborators about LiquiVent, she said. Time lines for filing new drug applications have not been established.
"We really haven't talked about that, on any of them," Rosenberg said. Of the three products, LiquiVent and Oxygent are "tied" for importance, she said. "LiquiVent is the one that grabs people's attention, because it's unique," she added. The treatment has been granted fast-track status by the FDA.
Alliance's stock (NASDAQ:ALLP) closed Monday at $4, down $0.312. n