By Kim Coghill
Despite preliminary data showing that partial liquid ventilation with LiquiVent (perflubron) failed to meet its primary or secondary endpoints, San Diego-based Alliance Pharmaceutical Corp. has not closed the door on its oxygen-carrying liquid.
The preliminary data from the Phase II/III clinical study in adult patients with acute respiratory distress syndrome did show LiquiVent was well tolerated, said Gwen Rosenberg, Alliance¿s vice president of corporate communications.
Nevertheless, Alliance will abandon partial liquid ventilation (PLV) with LiquiVent studies and pursue the use of the product for other indications at a later time.
¿Alliance¿s immediate focus will remain on our previously stated priorities, which are FDA approval for our Imavist ultrasound contrast agent and the resumption of clinical development of Oxygent, both of which are expected later this year,¿ a prepared statement by Duane Roth, Alliance¿s chairman and CEO, said.
Alliance¿s stock (NASDAQ: ALLP) closed Tuesday at $3.18, down $1.11, or 25.9 percent.
The Phase II/III LiquiVent study enrolled 311 adult patients at 56 medical centers in the U.S., Europe and Canada. The primary endpoint was improvement in ¿ventilator-free days¿ and the secondary endpoint was improvement in 28-day mortality.
The PLV with LiquiVent achieved a 19 percent mortality rate compared to 15 percent in the control group.
Before the study started, a 40 percent or higher rate of mortality in acute respiratory distress syndrome patients was acceptable. However, a National Institutes of Health study, which was not complete at the time Alliance¿s study began, showed an improvement in mortality by using ¿lung protective strategy¿ (low pressure ventilator) in mechanical ventilation.
¿The results of our trial have confirmed that lung protective ventilation can dramatically reduce lung injury,¿ said a prepared statement from Mark Wedel, LiquiVent program director. ¿The trial results also suggest that partial liquid ventilation does not provide incremental benefit when compared to these new ventilation strategies.¿
Rosenberg said LiquiVent may be tested for other uses including delivery of therapeutic agents such as antibiotics or genes directly into the lungs or as a lavage (lung washing) agent.
Meanwhile, she said Alliance will focus on its other products.
This recent drop in stock price is not an entirely new phenomenon for Alliance, which faced a dramatic decline in January when the company had to suspend enrollment of a Phase III cardiac study of Oxygent. The company¿s stock dropped 68 percent that day to close at $2.375. (See BioWorld Today, Jan. 10, 2001.)
But by mid-March, the stock was climbing when the company released data showing the trial design was the culprit, not the drug. And then, in April, the stock jumped again when the company released promising data in trials of Oxygent in general surgery patients. (See BioWorld Today, April 10, 2001.)