British Biotech plc - Lexipafant is effective in Phase II trials of acute pancreatitis.OXFORD, England--(BUSINESS WIRE)--Sept. 14, 1995-- Highlights o Lexipafant has successfully completed a Phase II placebo-controlled randomised Adj. 1. randomised - set up or distributed in a deliberately random way randomized irregular - contrary to rule or accepted order or general practice; "irregular hiring practices" clinical trial in patients with acute pancreatitis acute pancreatitis Inflammation of the pancreas of abrupt onset, often with gallstones and alcohol ingestion Epidemiology 109,000 hospitalizations, 2251 deaths–US; 10-fold ↑ from 1960s to 1980s–reason unclear; . o The results of the trial were positive and showed a statistically significant reduction in organ failure scores in patients treated with lexipafant. o The results confirm the positive results with lexipafant in an earlier randomised clinical trial in patients with acute pancreatitis. o Lexipafant is believed to be the first specific drug therapy to show statistically significant benefit in acute pancreatitis. o British Biotech British Biotech was a British based biotech company. British Biotechnology Limited was founded in 1986 by former G D Searle managers Keith McCullagh and Brian Richards, [1] has commenced a pivotal Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial in the UK aimed at achieving European registration of the drug. o In the USA, an IND has been granted by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. to allow a Phase II/III clinical trial in acute pancreatitis and this study will begin in the fourth quarter of 1995. Commenting, Dr Peter Lewis, Director of Research and Development, said "These results with lexipafant are very encouraging. The clinical results from our two Phase II trials provide convincing evidence of efficacy and safety in what is a life-threatening condition. There are no effective drugs for pancreatitis and we intend to progress this new drug rapidly to regulatory submission". British Biotech plc Lexipafant is effective in Phase II trials of acute pancreatitis British Biotech plc announces a positive outcome in a Phase II placebo-controlled clinical trial of lexipafant in patients hospitalised with acute pancreatitis. The detailed results were presented yesterday by Colin McKay Colin McKay (born August 29, 1975 in Vancouver, British Columbia) is a professional skateboarder from Canada. McKay began skating in 1986 and honed and progressed his skateboard skills at Kevin Harris' Richmond Skate Ranch. FRCS FRCS Fellow of the Royal College of Surgeons. FRCS abbr. Fellow of the Royal College of Surgeons at the Fifth International Congress on Platelet-Activating Factor A platelet-activating factor, also known as a PAF, PAF-acether or AGEPC (acetyl-glyceryl-ether-phosphorylcholine) is a potent phospholipid activator and mediator of many leucocyte functions, including platelet aggregation, inflammation, and anaphylaxis. and Related Lipid Mediators in Berlin. The trial showed a statistically significant improvement in organ function in patients receiving lexipafant compared with those on placebo. The results suggest that patients with acute pancreatitis who are treated with lexipafant have a reduced risk of developing organ failure, are more likely to recover quickly from organ dysfunction and are less likely to require prolonged treatment in intensive care units (ICUs). This second Phase II trial supports the results of an earlier Phase II trial of lexipafant in patients with varying degrees of severity of acute pancreatitis. In this previous trial, patients treated with lexipafant also had a lower incidence of organ failure. Taken together, the two Phase II trials provide convincing evidence for the efficacy and safety of lexipafant in the treatment of pancreatitis. British Biotech believes that lexipafant is the first specific therapy to have shown a statistically significant benefit in pancreatitis. Pancreatitis Pancreatitis is a disease characterised by an acute inflammation acute inflammation n. Inflammation having a rapid onset and coming to a crisis relatively quickly, with a clear and distinct termination. of the pancreas. It is an extremely painful condition which may lead to failure of organ function, particularly lung failure. This complication of organ failure frequently requires intensive care treatment and may lead to death. There are approximately 250,000 cases of pancreatitis per year in the USA and up to 100,000 per year in Europe. The great majority of these patients are at risk of developing severe disease. Patients who develop severe pancreatitis with complications may require intensive care for long periods of up to two months or more. Despite intensive care, mortality in acute pancreatitis remains high, with 8-10% of patients dying of the disease. There is currently no approved specific drug treatment for pancreatitis in the USA or the UK. Aim of the trial The objective of the second Phase II trial was to assess the effect of lexipafant treatment on the clinical outcome and markers of inflammation in patients with severe acute pancreatitis. Design of study A total of 51 patients were randomised to receive either active treatment with lexipafant or placebo in a double-blind study double-blind study, n experimental technique in clinical research in which neither the researcher nor the patient knows whether the treatment administered is considered inactive (placebo) or active (medicinal). , co-ordinated by the principal clinical investigator A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under , Mr C.W. Imrie, senior lecturer senior lecturer n. Chiefly British A university teacher, especially one ranking next below a reader. in surgery, Glasgow Royal Infirmary The Glasgow Royal Infirmary (GRI) is a large teaching hospital, operated since 1947 by NHS Scotland, situated on the north-eastern edge of the city centre of Glasgow, Scotland at . University NHS Trust National Health Service Trusts (NHS Trusts) provide many services of the National Health Service in England and Wales. They are not trusts in the legal sense but are in effect public sector corporations. , Scotland. The APACHE II APACHE II ("Acute Physiology and Chronic Health Evaluation II") is a severity of disease classification system (Knaus et al., 1985), one of several ICU scoring systems. After admission of a patient to an intensive care unit, an integer score from 0 to 71 is computed based on scoring system Noun 1. scoring system - a system of classifying according to quality or merit or amount rating system classification system - a system for classifying things was used to assess patients. All patients required an APACHE II score of greater than five at the time of hospitalisation to be entered into the trial. Patients randomised to the active treatment group received a continuous intravenous infusion of 100mg of lexipafant per 24 hours for up to one week. Patients were assessed clinically for seven days. Physiological and laboratory data were collected daily from which organ failure scores were computed. Results of the trial Patients treated with lexipafant, when compared to those receiving placebo, showed an overall reduction in mean organ failure scores which was statistically highly significant. The mean organ failure score in 27 patients on lexipafant reduced by 1.3 units whereas it rose in the 24 placebo patients by 0.2 units. The effects of lexipafant treatment compared to placebo were due to a faster recovery from organ failure in patients who entered the study with severe disease and to the prevention of new organ failure occurring in patients who entered the study with less severe disease. As a result, there was a greater reduction in the number of patients with organ failure during treatment with lexipafant than on placebo. Some 16 of the 27 lexipafant patients had organ failure on admission. This fell to seven by the end of treatment. By contrast nine of the 24 placebo patients had organ failure on admission and this hardly changed, to eight, at the end of treatment. Fewer patients died in the lexipafant group, four, than in the placebo group, six. The mortality of 25% in the placebo treated patients underlines the poor prognosis of acute pancreatitis. Earlier Phase II trial In 1994, an initial Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II in pancreatitis was carried out in five UK centres co-ordinated by Andrew Kingsnorth FRCS, Liverpool, England. This study included 83 patients with all degrees of severity of pancreatitis and concentrated on measuring inflammatory markers rather than clinical outcome. The results of this earlier Phase II trial were released in September 1994. There was a consistent trend towards improvement in clinical condition of the patients and inflammation of the pancreas in the lexipafant treated patients compared with those randomised to placebo. More detailed analysis of the data from this study has revealed a similar pattern of improvement in organ failure to that seen in the second Phase II trial described above. These results were presented at a meeting of the American Pancreatic Club in San Diego recently. Further clinical trials A multicentre, Phase III, double-blind placebo-controlled trial in 300 patients with acute pancreatitis began in the UK in November 1994. As in the Glasgow Phase II study reported today, this study is assessing clinical outcome in patients at a high risk of developing severe disease requiring treatment in an intensive care unit. This study is proceeding well and will complete recruitment in 1996. In the United States, an IND has been approved to begin a 200 patient, randomised placebo-controlled, trial of lexipafant in the treatment of acute pancreatitis, involving 25 hospital centres. This trial is due to start in the fourth quarter of 1995 and will be the first study of lexipafant in the USA. Provided the results of these pivotal trials in Europe and the USA confirm the positive outcome of Phase II trials, British Biotech expects to seek European and North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. regulatory approval for the marketing of lexipafant as a new drug for the treatment of acute pancreatitis. CONTACT: For further information please contact: British Biotech plc On 9/14/95: 011-44-171 253 2252 or Peter Lewis, Director of Research & Development Thereafter: 011-44-1865 748747 James Noble, Finance Director Katie Arber, Head of Corporate Communications or British Biotech Inc. 410/266-7909 Peter P. McCann, President or G.A. Kraut kraut n. 1. Sauerkraut. 2. often Kraut Offensive Slang Used as a disparaging term for a German. [German; see sauerkraut.] Noun 1. Company 212/696-5600 Gerard Coffey, Vice President |
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