GOTHENBURG, Sweden, Sept. 22, 2004 (PRIMEZONE) -- The Gothenburg-based drug development company Arexis AB today announced that its novel project on bile salt-stimulated lipase (BSSL), an enzyme present in human milk, has received financial support from the EU. A clinical Phase II trial will commence in 2005.
The study is part of the EU's 6th Framework initiative EARNEST, which includes integrated epidemiological, genetic, animal, consumer and economic research on improved nutrition for preterm infants and its implications for health in adult life.
"It is an important recognition for Arexis that our very promising BSSL program will be included within this prestigious and competitive European framework. We will work closely together with a strong network of the best European experts in this field," said Dr Lennart Hansson, CEO at Arexis. "On a longer term basis, substantial medical needs will be met and we expect this to have significant financial importance for Arexis," he concluded.
BSSL has a key function to metabolize a large spectrum of lipids in food. In the Arexis study, this enzyme is being developed for neonatal indications. Preterm infants are at risk for increased morbidity and mortality, and they often remain small throughout life. Compared to healthy infants, they more often experience metabolic, cognitive, social and behavioral problems.
Recombinant human BSSL is highly attractive to use as an ingredient in novel products for preterm infants. This is due to the facts that naturally occurring BSSL in breast milk is inactivated upon pasteurization and lipase activity is not present in formula or nutritional additives.
It is anticipated that BSSL nutrition will improve weight gain and growth in preterm and other vulnerable infant groups, as a result of improved dietary fat absorption. There is reason to believe that it will reduce time spent in the neonatal intensive care unit and improve long-term development.
Arexis recently announced the completion of a successful clinical Phase II study on BSSL for the treatment of pancreatic insufficiency in adult cystic fibrosis patients. A clinical Phase III study is now being planned.
Notes to editors:
BSSL
BSSL (bile salt-stimulated lipase) is a naturally occurring enzyme with a key function to metabolize a large spectrum of lipids in food. It is present in the mature pancreas and in breast milk. BSSL plays a key role in catalyzing the digestion of milk triglycerides, the major source of energy, and long-chain polyunsaturated fatty acids (LCPUFAs) for infants. For pharmaceutical use, recombinant human BSSL will be manufactured in a cell culture system.
EARNEST EARLY
Nutrition program and a long-term follow-up of Efficacy and Safety Trials. The program includes integrated epidemiological, genetic, animal, consumer and economic research. It will start in April 2005 and continue for five years. It is part of the European Union's Sixth Framework Program (FP6), which is the main instrument for EU's funding of research in Europe. The overall FP6 budget covering the four-year period 2003-2006 is Euro 17.5 billion, of which Euro 2,255 million is for life sciences, genomics and biotechnology research.
Preterm infants
The gestation period for humans is 37- 41 weeks, and infants born at less than 37 weeks of gestational age are considered preterm. Preterm infants are also classified by birth weight, with a birth weight of less than 2,500g considered Low Birth Weight (LBW). The preterm infants are at risk for increased morbidity and mortality, and compared to healthy infants, they more often experience metabolic, cognitive, social and behavioral problems later in life.
About Arexis
Arexis is a privately owned drug development company with an attractive portfolio of projects, ranging in development from pre-clinical to near commercial stages. Arexis focuses on development of drugs to treat metabolic and inflammatory diseases, such as fat mal-absorption, diabetes, atopic dermatitis and rheumatoid arthritis. These are areas with great unmet medical need and largely unknown disease mechanisms. Arexis has a strong intellectual property and technology platform. The company was founded in 1999 and operates in custom-designed laboratories in the newly built Biotech Center in Gothenburg, Sweden. For more information, please visit www.arexis.com
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