Last checked at 1 Jun 2011 07:00
1 June 2011
Provexis plc
Update on Crohn's disease trial
Provexis plc ("Provexis" or the "Company"), the life-science business that discovers, develops and licenses scientifically-proven functional food, medical food and dietary supplement technologies, announces an interim update on its NSP#3G human trial targeted at maintaining remission in Crohn's disease patients.
A fully independent Data Monitoring Committee ("DMC") has reviewed the data gathered from the first patients to complete the full 12 months of treatment. The DMC's role is to look at the efficacy and safety data generated in the study and to provide ongoing advice to Provexis on its completion.
Following their review, the DMC has confirmed that there are no negative findings associated with this initial dataset and no safety concerns related to the administration of the test product. The DMC recommended a further interim review of the study be conducted in Q4 2011. The interim review findings are in line with the Company's expectations.
Following this advice, Provexis intends to identify up to four additional trial centres to facilitate full recruitment of the remaining patients required, to enable it to complete the trial in the shortest feasible timeline. The Directors have previously noted that the recruitment of patients for clinical trials in the area of inflammatory bowel disease is recognised as being challenging across the industry. The Company remains committed to this key technology and believes that opening extra trial centres will expedite the trial and support initial commercial discussions with corporate partners.
The Company's Liverpool-based R&D team will also continue to research and characterise NSP#3G extracts for addressing C.difficile, the so-called hospital 'super bug', and antibiotic-associated diarrhoea.
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For further information please contact:
Stephen Moon, Chief Executive
Provexis plc Tel: 01753 752290
Patrick Castle/Bobbie Hilliam Tel: 020 7071 4317
Evolution Securities
Haggie Financial LLP: Tel: 020 7417 8989
Matthew Longbottom matthew.longbottom@haggie.co.uk
Notes to Editors
About Provexis plc
AIM-listed Provexis is focused on the discovery, development and licensing of technologies for the functional food, dietary supplement and medical food sectors.
The company was originally spun out of the Rowett Institute (now part of the University of Aberdeen) in 1999 to commercialise their tomato extract discovery using venture capital funding. Provexis Limited was reversed into Nutrinnovator in 2005 and its major investors are DSM Venturing and Rising Stars Growth Fund (part of Enterprise Ventures).
The company's first technology is a patented tomato extract for reduction of platelet aggregation. This technology was the first to receive an approved health claim from the EC under Article 13(5) and in June 2010 the technology was licensed to DSM Nutritional Products. The company has additional biotechnology developments, including a joint venture with the University of Liverpool to develop an extract of plantain which aids the treatment of inflammatory bowel disease. Provexis has a collaboration with the Institute of Food Research to develop natural extracts for systemic inflammation. The initial target is the reduction of cardiovascular inflammation and longer-term targets include the reduction of risk of certain cancers.
About DSM Nutritional Products
DSM Nutritional Products, a wholly-owned business unit of Royal DSM N.V., is the world's leading supplier of vitamins, carotenoids and other fine chemicals to the feed, food, pharmaceutical and personal care industries. The business has sales of over €3 billion and a long tradition as a pioneer in the discovery of new products, new formulations and attractive applications for all industry segments.
About Royal DSM N.V.
Royal DSM N.V. creates solutions that nourish, protect and improve performance. Its end markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrical and electronics, life protection and housing. DSM manages its business with a focus on the triple bottom line of economic prosperity, environmental quality and social equity, which it pursues simultaneously and in parallel. DSM has annual net sales of €8.18 billion and employs some 21,900 people worldwide. The company is headquartered in the Netherlands, with locations on five continents. DSM is listed on Euronext Amsterdam.