20th Sep 2005 07:01
Evolutec Group PLC20 September 2005 For immediate release 20 September 2005 EVOLUTEC GROUP PLC ("Evolutec" or "Company") POSITIVE PHASE II CLINICAL RESULT FOR rEV131 IN SEASONAL ALLERGIC RHiNITIS (HAY FEVER) Trial meets primary endpoint; rEV131 shows efficacy and rapid onset of action Conference call for analysts today at 3pm BST Evolutec Group plc (AIM: EVC), the biopharmaceutical company developing novelproducts for the treatment of allergic, inflammatory and autoimmune diseases, ispleased to announce, ahead of schedule, a positive clinical trial result for itslead molecule, rEV131, in a 112 patient Phase II study in allergic rhinitis (hayfever). rEV131 is a recombinant version of a naturally occurring molecule identified inticks, parasites whose saliva contains immuno-suppressive and immuno-modulatorymolecules over which Evolutec has strong patent protection. This Phase II dose-ranging nasal allergen challenge study of rEV131 administeredas a nasal spray was undertaken at two centres in San Antonio, Texas, under theleadership of Dr Paul Ratner. The trial was conducted in accordance with theFood & Drug Administration's Guidance for Industry recommendations. The trial comprised four cohorts of 20 patients (16 active, 4 placebo), with theactive patients on ascending single doses of rEV131, followed by a fifth cohortof 32 patients (16 active, 16 placebo) at the optimum dose. The ragweed pollenextract was administered 30 minutes after dosing. The trial met its primary endpoint, a statistically significant difference (p<0.05) in the mean sum of symptom scores at 15 minutes post allergen challenge inthe 62 patients who completed the trial according to the protocol. rEV131 showeda dose dependent drug effect enabling Evolutec to select the optimum dose forfurther work to determine the onset of action and the duration of effect. Therewere no significant adverse events and rEV131 was comfortable andwell-tolerated. This result shows that rEV131 has an onset of action of 45 minutes or less -quicker than steroid nasal sprays which have an onset of action of approximately8 hours. The main effects of rEV131 were against congestion and mucusproduction, symptoms that patients find the most troublesome and which are notwell addressed by oral antihistamines. The rapid onset of action and efficacyagainst congestion and mucus underpin the potential commercial advantages ofrEV131. Mark Carnegie Brown, Evolutec's Chief Executive Officer, commented: "This resulthighlights the potential of rEV131 in the $6 billion allergic rhinitis market.We now intend to undertake a multi-dose Phase II study to define further theonset and duration of action which will guide commercial positioning. We willalso continue our dialogue with potential partners." Dr. Paul Ratner, principal study investigator and Fellow of the American Academyof Asthma, Allergy & Immunology, commented: "I am excited about the prospect ofa novel therapeutic agent for the treatment of allergic rhinitis that is safe,effective within 45 minutes and delivered via the intranasal route." ENDS Conference call: A conference call for analysts will be held at 3.00pm BST today to discuss theresult. The principal study investigator, Dr. Paul Ratner, will join the call. Dial-in details: UK 0845 245 0375 International +44 (0) 1452 555 499 PIN 734265# For further information: Evolutec 0118 922 4480 Mark Carnegie Brown, Chief Executive Officer Nicholas Badman, Chief Financial Officer www.evolutec.co.uk Robert W. Baird 020 7488 1212 Shaun Dobson/Xavier de Mol Buchanan Communications 020 7466 5000 Mark 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 just completed a positive 112 patient proof of concept Phase IIclinical trial with rEV131, its lead product, in allergic rhinitis. The companyhad previously demonstrated clinical activity against the symptoms of rhinitiswhen rEV131 was delivered as an eye drop. Evolutec intends to carry outadditional proof of concept Phase II trials with rEV131 in post-cataract surgeryand dry eye. Positive preclinical data has also been generated in asthma.rEV131 is a histamine binding protein and is understood to be the only productcurrently in clinical trials that impacts the recently discovered H4 receptor, areceptor implicated in many forms of inflammatory disease. The Company has a further two molecules in preclinical development. rEV576, acomplement inhibitor which was very effective in a preclinical model ofmyasthenia gravis, and rEV598, which is being evaluated in carcinoid syndromeand CINV (chemotherapy-induced nausea and vomiting). Evolutec is working withMerial to develop anti-tick and anti-tick borne disease vaccines. Evolutec was founded in 1998 to exploit research carried out by the NaturalEnvironment Research Council. Evolutec's drugs were first isolated from thesaliva of ticks but are now manufactured by bacterial fermentation procedures.The tick remains undetected by its hosts, including humans, by injecting anarray of molecules into the skin that suppresses normal defence mechanisms.These stealth molecules have evolved over millions of years to enable the tickto take a blood meal from its host. Evolutec employs the tick's evolutionarystealth technology 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 ExchangeRelated Shares:
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