The Liposome Co. Inc. started a pivotal Phase III trial ofits liposomal prostaglandin E1 (PGE1) to treat acuterespiratory distress syndrome (ARDS), an often-fatalcondition in which liquid leaks from injured bloodvessels into the lungs.

The randomized, double-blind, placebo-controlled studywill involve about 350 patients at 40 to 50 U.S. centers.Lung function in study participants must havedeteriorated to the point that mechanical ventilation isrequired. The primary endpoint is time to the patients'removal from the ventilation.

The study is expected to take about two years, saidBrooks Boveroux, the company's vice president, finance,and chief financial officer. He said a separate trial using adifferent dosing regimen is expected to begin in Europeby the end of the year.

The Princeton, N.J., company is developing the drug,called TLC C-53, without a partner. "We're going to keepthis to ourselves because the development costs aremanageable, the time is manageable and we think theproduct has a very high potential value. Since it would bedistributed to hospital settings, we could afford thedistribution costs."

There are no drugs that have proved effective against thedisease, which affects about 150,000 people per year inthe U.S., the company said. The condition stems from avariety of insults, such as trauma, burns and sepsis.

The company released the news to investment analystsnear market-closing time on Wednesday, when TheLiposome Co.'s stock (NASDAQ:LIPO) gained 25 cents.It fell 13 cents Thursday to close at $17.13.

The Liposome Co. achieved statistically significantresults in some endpoints of a 25-patient Phase II study,which were reported last February.

Investigators said all eight placebo patients still requiredassisted ventilation eight days after treatment, while onlynine of 17 TLC C-53 patients needed the assistance. Byday eight, 13 of 17 drug-treated patients had at least a 25percent improvement in lung compliance or wereremoved from the ventilator, while none of the placebopatients achieved that status. Mortality at 28 days was 6percent in the TLC C-53 compared to 25 percent in theplacebo group, the only result that wasn't statisticallysignificant in the small study. n

-- Jim Shrine

(c) 1997 American Health Consultants. All rights reserved.