British Biotech plc's stock gained 18 percent Thursday onPhase II results that showed lexipafant had a statisticallysignificant improvement of organ function in patientswith acute pancreatitis.
Results of the randomized, double-blind, placebo-controlled 51-patient trial suggest that those treated withthe small molecule have a reduced risk of developingorgan failure, are more likely to recover quickly fromorgan dysfunction and are less likely to require prolongedtreatment in intensive care units, the company said.
"This is the first time any drug was shown to be effectivein the treatment of acute pancreatitis," Keith McCullagh,CEO of British Biotech, told BioWorld Today. "This isalso one of the first times a PAF [platelet activatingfactor] receptor antagonist has been shown to be effectivein the treatment of systemic inflammatory disease."
Shares of the Oxford, England, company(NASDAQ:BBIOY) gained $3.25 Thursday to close at$21.50.
Lexipafant is a small molecule drug synthesized to blockactivation of receptors for PAF. Patients in the treatmentgroup received a continuous intravenous infusion of 100mg of drug per 24 hours for up to one week.
Sixteen patients in the drug group had organ failure uponadmission into the trial. Nine of them had restored organfunction after the study. In contrast, eight of nine patientsin the placebo group who entered the study with organfailure still had it after treatment.
Pancreatitis is characterized by acute inflammation in thepancreas, and may lead to organ failure. About 10 percentof the 250,000 pancreatitis patients each year in the U.S.will die from the disease, the company said.
British Biotech began a 300-patient Phase III trial in theU.K. last year. The design is similar to the Phase II study.Last week the FDA approved a 200-patient Phase II/IIIU.S. study, which is expected to start in the fourth quarterand will be the first U.S. trial of the drug. McCullagh saidboth studies should be completed in 1996.
An earlier Phase II study of lexipafant was geared moretoward showing changes in inflammatory markers ofdisease, which it did, particularly in interleukins.
Results of the study were presented in Berlin at the FifthInternational Congress on Platelet-Activating Factor andRelated Lipid Mediators. n
-- Jim Shrine
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