Nanoco Regulatory News (NANO)

14 Dec 2006 07:01

Evolutec Group PLC14 December 2006 Thursday 14 December 2006 Evolutec Group plc ("Evolutec" or "the Company") Review confirms rEV131 allergic rhinitis result Phase II post-cataract inflammation result expected in January 2007 Evolutec Group plc (AIM: EVC), the biopharmaceutical company developing novelproducts for the treatment of allergic, inflammatory and autoimmune diseases,announces that it has completed its quality assurance review of the recentlyconducted allergic rhinitis clinical trial. The review confirmed that the rEV131drug product and the implementation of the protocol were as specified. The recent Phase IIb trial represented a higher hurdle, with patients beingexposed to much greater levels of ragweed pollen than in the previous Phase IIatrial. As a result, patients showed twice the allergic symptom score than inthe previous trial. Thus the lack of efficacy observed may well have beenbecause the amount of histamine released exceeded the binding capacity ofrEV131. Evolutec has no plans to make further investment in rEV131 in allergicrhinitis. rEV131 is also in a Phase II clinical trial in post-cataract inflammation whichwill report in January 2007. The study aims to demonstrate theanti-inflammatory potential of rEV131 following cataract surgery. The trial isplacebo controlled and includes the standard of care, prednisolone, as an activecomparator. The primary endpoint of this 150 patient, dose-ranging proof ofconcept trial is lack of eye inflammation two weeks after surgery. If theresults are positive, the Company intends to seek a partner for the rights torEV131 in ophthalmology. Post-cataract inflammation and allergic rhinitis are separate unlinkedindications and were selected to test rEV131's efficacy as an anti-inflammatoryand anti-allergy therapeutic respectively. Mark Carnegie Brown, Chief Executive of Evolutec, said: "Despite the setback inrhinitis, we remain positive about the outcome of the post-cataract studybecause the pharmacokinetics and inflammatory drivers are different in thisindication. Following the clinical trial result in January, we will seek adialogue with shareholders to discuss our plans and business developmentactivities." Enquiries: Evolutec 0118 922 4480Mark Carnegie Brown, Chief Executive OfficerNicholas Badman, Chief Financial Officerwww.evolutec.co.uk Financial Dynamics 020 7831 3113David YatesBen Brewerton About Evolutec Evolutec, which is based in Reading, UK, is a clinical stage biopharmaceuticalcompany with a focus on allergy, inflammation and autoimmune diseases. rEV576, the Company's second product development candidate is a complementinhibitor which has demonstrated preclinical activity against the autoimmunediseases myasthenia gravis and Guillain-Barre Syndrome, asthma and acutemyocardial infarction ("AMI") (heart attack). Evolutec has established aresearch collaboration with Case Western Reserve University, Cleveland, Ohio, toundertake further preclinical work with rEV576 in myasthenia gravis. The Companyexpects to commence clinical trials with rEV576 in 2007. The rights to Evolutec's vaccine technology for animals are partnered withMerial. Merial is currently undertaking work in tick-borne diseases. Evolutec is listed on the AIM market of the London Stock Exchange and developstherapeutics originally isolated from the saliva of ticks. The tick remainsundetected by its hosts, including humans, by injecting an array of moleculesinto the skin that suppresses host immunity. These stealth molecules haveundergone millions of years of natural evolution to select a promising efficacy,potency and safety profile. Evolutec employs the tick's evolutionary stealthtechnology to offer the potential of treating human diseases. This information is provided by RNS The company news service from the London Stock Exchange