British Biotech plc has launched a Phase III clinical trial in the U.K.of lexipafant, a platelet activating factor antagonist, for treatment ofacute pancreatitis.
The study will involve 300 patients in 15 hospitals and will be usedto support regulatory approvals in the U.K. and Europe.
Peter McCann, president of the Oxford, England-based company'sU.S. operations in Annapolis, Md., said British Biotech expects tobegin Phase II trials of the drug in the U.S. by the second quarter ofnext year and Phase III studies in the fourth quarter of 1996.
He said the Phase III trials in the U.K. should be complete by thethird or fourth quarter of 1996. The study's primary endpoint is toreduce inflammation in patients suffering from acute pancreatitis,which is most often caused by excess alcohol use or gall stones.
Lexipafant is a small molecule drug synthesized to block activationof receptors for platelet activating factor, which has been linked to avariety of inflammatory diseases, including pancreatitis and asthma.
Patients participating in the placebo-controlled trials will receive aninfusion of 100 milligrams of lexipafant per day for up to sevendays.
In addition to developing an intravenous solution of the drug, BritishBiotech is collaborating with Glaxo Holdings plc, of London, on anoral tablet form of lexipafant for treatment of acute asthma.
The phase III trial in the U.K. is the second late-stage study underway by British Biotech. The company last week started a Phase IIItrial of batimastat, a matrix metalloproteinase inhibitor, in Europe fortreatment of malignant ascites in patients with late-stage ovarian andabdominal cancers. _ Charles Craig
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