16th Nov 2006 07:00
Evolutec Group PLC16 November 2006 Thursday 16 November 2006 Evolutec Group plc ("Evolutec" or "the Company") Clinical Trial Update Phase II Post-cataract Eye Inflammation Trial is Fully Recruited Results Expected Early 2007 Evolutec (AIM: EVC), the biopharmaceutical company developing novel products forthe treatment of allergic, inflammatory and autoimmune diseases, announces thatits proof of concept Phase II trial with its lead compound, rEV131, againstinflammation following cataract surgery is fully recruited. With today's announcement, the Company expects the trial results to be publishedearly in the New Year. This is the result of an acceleration in the recruitmentof patients after Evolutec increased the number of centres participating in thetrial from 10 to 15. This updates the announcement by the Company in Septemberthat initial recruitment of the required 150 patients had been slow and that thetrial results were likely to be delayed until H1 2007. This randomised double-blind trial is being co-ordinated by Ophthalmic ResearchAssociates ("ORA"), North Andover, Massachusetts, under the leadership of DrMark B. Abelson, MD. It will compare the anti-inflammatory effects of rEV131versus placebo and the steroid prednisolone. Prednisolone is the most widelyprescribed treatment for post-operative inflammation of the anterior segment ofthe eye. rEV131, dosed twice a day, will be compared with prednisolone, dosed four timesa day over a two week period. The primary endpoint of the trial is inflammationat 14 days. This trial follows a successful preclinical study showing rEV131 to be aseffective as prednisolone. The Company believes the value of the post-cataractsurgery inflammation market to be approximately $500 million. Enquiries: Evolutec 0118 922 4480Mark Carnegie Brown, Chief Executive OfficerNicholas Badman, Chief Financial Officerwww.evolutec.co.uk Financial Dynamics 020 7831 3113David YatesBen Brewerton Notes for Editors: About Evolutec Evolutec, which is based in Reading, UK, is a clinical stage biopharmaceuticalcompany with a focus on allergy, inflammation and auto-immune diseases. The Company has completed a positive 112 patient proof of concept Phase IIaclinical trial with rEV131, its lead product development candidate, in allergicrhinitis. rEV131 met the primary endpoint of reducing the sum of symptom scoresat statistically significant levels within 45mins of administration. rEV131 iscurrently being evaluated in a 300 patient Phase IIb clinical trial in allergicrhinitis which is expected to report by the end of 2006. In addition to thePhase IIb trial in rhinitis and the proof of concept Phase II trial inpost-cataract, Evolutec also intends to complete a proof of concept Phase IItrial in dry eye in 2007. Following positive preclinical data, Evolutec intendsto undertake a Phase I trial with rEV131 in asthma in 2007. 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 ExchangeRelated Shares:
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