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Ph II Cataract Trial Starts

20th Jun 2006 07:01

Evolutec Group PLC20 June 2006 For immediate release 20 June 2006 EVOLUTEC GROUP PLC ("Evolutec" or "the Company") COMMENCEMENT OF PHASE II TRIAL IN THE TREATMENT OF INFLAMMATION FOLLOWING CATARACT SURGERY Evolutec Group plc (AIM: EVC), the biopharmaceutical company developing novelproducts for the treatment of allergic, inflammatory and autoimmune diseases, ispleased to announce the commencement of a 150 patient proof of concept Phase IItrial with its lead compound, rEV131, against inflammation following cataractsurgery. The trial will compare the anti-inflammatory effects of rEV131 versusprednisolone, the current standard of care, and placebo in post-operativeinflammation of the anterior segment of the eye. This randomised double-blind trial is being co-ordinated by Ophthalmic ResearchAssociates ("ORA"), Boston, Massachusetts, under the leadership of Dr Mark B.Abelson, MD. The trial will take place at 10 ophthalmic surgical centres acrossthe US. This trial follows a successful preclinical study showing rEV131 to beas effective as prednisolone 1.0%, a corticosteroid. rEV131, dosed twice a day, will be compared with prednisolone, dosed four timesa day over a two week period. The primary endpoints of the trial are flare andcell counts, which are accepted by the US Food and Drug Administration ("FDA")for measuring inflammation in the anterior chamber of the eye. The Company believes the value of the post-cataract surgery inflammation marketto be approximately $500 million. Mark Carnegie Brown, Evolutec's Chief Executive Officer, commented: "The startof this trial follows the commencement of a 300 patient Phase IIb trial ofrEV131 in allergic rhinitis (hay fever) as announced earlier this month. Thisadded momentum represents a step change in Evolutec's news flow with both trialresults anticipated by the end of 2006." ENDS For further information:Evolutec 0118 922 4480Mark Carnegie Brown, Chief Executive OfficerNicholas Badman, Chief Financial Officerwww.evolutec.co.uk Buchanan Communications 020 7466 5000Mark Court/Tim Anderson/Mary-Jane Johnson 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. In additionto the Phase 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 2006/7. Following positive preclinical data, Evolutecintends to carry out a Phase I trial of rEV131 in asthma in 2007. The Company has a further two product development candidates in pre-clinicaldevelopment: rEV576, a complement inhibitor, and rEV598, which is beingevaluated in CINV (chemotherapy-induced nausea and vomiting). rEV576 hasdemonstrated preclinical activity against the autoimmune disease myastheniagravis and in acute myocardial infarction ("AMI") (heart attack). Evolutec hasa research collaboration with Case Western Reserve University, Cleveland, Ohio,to carry out further preclinical testing of rEV576 in myasthenia gravis. The rights to Evolutec's vaccine technology for animals are partnered withMerial, which 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. Safe Harbour statement: this news release may contain forward-looking statementsthat reflect the current expectations of the Company regarding future events.Forward-looking statements involve risks and uncertainties. Actual events coulddiffer materially from those projected herein and depend on a number of factorsincluding the success of the Company's research strategies, the applicability ofthe discoveries made therein, the successful and timely completion of clinicalstudies, the uncertainties related to the regulatory process, the successfulintegration of completed mergers and acquisitions and achievement of expectedsynergies from such transactions, and the ability of the Company to identify andconsummate suitable strategic and business combination transactions. This information is provided by RNS The company news service from the London Stock Exchange

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