Synairgen Regulatory News (SNG)

15 Nov 2005 07:02

Synairgen plc15 November 2005 SYNAIRGEN PLC INTERFERON-Beta ENTERS CLINIC FOR NOVEL USE IFN-Beta to be used to treat virus-induced asthma exacerbations Southampton, UK - Synairgen plc ('Synairgen' or the 'Company'), the drugdiscovery company focused on the underlying causes of asthma and chronicobstructive pulmonary disease (COPD), is pleased to announce that the firstsubject has been enrolled into the Phase I clinical trial to assess the safetyand tolerability of inhaled interferon-Beta ('IFN-Beta'). The rhinovirus or cold virus is the most common trigger for the worsening ofasthma symptoms (otherwise known as an asthma exacerbation), particularly amongsevere asthmatics. Building on successful data derived from its proprietary invitro models of the disease, Synairgen is investigating a novel application ofinhaled IFN-Beta to reduce exacerbations caused by the cold virus. Currentlythere are no satisfactory treatments available to address this significant unmetneed in asthma. The total cost of asthma in the United States is $16bn per annum, and thisincludes some $4.1bn for emergency department visits and in-patient care. It hasbeen shown that c.10% of the asthmatic population who suffer from severe asthmatake up over 50% of the total cost of the disease. Genentech's Xolair(R) is thefirst drug aimed primarily at the allergic portion of the severe population. If the planned trials are successful, it is intended that Synairgen's inhaledIFN-Beta will provide a first line of defence for many of the asthmaticpopulation for whom there is currently no effective treatment for cold-inducedepisodes. Professor Stephen Holgate, one of the academic founders and non-executivedirectors of Synairgen, said, "Asthmatics live on a knife edge fearing anexacerbation. Our models of human disease have shown that asthmatic airwaysproduce little or no IFN-Beta which acts as a defence against the virus'sability to replicate. This has led us to develop an inhaled IFN-Beta programmeand we hope to demonstrate the utility of this approach in a proof of conceptstudy of therapeutic efficacy which will follow these safety studies". "There is a large market for a treatment capable of preventingrhinovirus-induced asthma exacerbations," added Richard Marsden, ManagingDirector of Synairgen. "There are two million emergency department visits due toasthma per year in the US alone; at least 50% of these visits will have beentriggered by the common cold. In addition, with the rise of "alternate site" (ienon hospital) treatment, many more asthma sufferers seek help from their generalpractitioner or specialist physician in the Doctor's Office setting. "We are optimistic that an inhaled IFN-Beta therapy could fill a significant gapin the chest physician's armoury."The trial is being conducted at the University of Southampton by Professor RatkoDjukanovic (one of Synairgen's founders) and will comprise 27 subjects. Theoutcome of this study will determine the extent of further safety studiesneeded. Injectable IFN-Beta is used to treat multiple sclerosis and various forms arecurrently marketed by Biogen IDEC Inc, Schering AG., Pfizer Inc., and Serono SA. -Ends- For further information, please contact: Synairgen Tel: 02380 512 800Richard Marsden, Managing Director Hogarth Partnership Tel: 020 7357 9477Melanie Toyne-SewellGeorgina Briscoe Notes to Editors 1. Background to the Company Synairgen was founded by Professors Stephen Holgate, Donna Davies and RatkoDjukanovic (the 'Founders'), a world-renowned respiratory research team from theUniversity of Southampton (the 'University'), and spun-out from the Universityin June 2003. In October 2004 the Company floated on AIM, raising £10.0 million(£9.0 million net of expenses) to enhance its research and developmentcapabilities and invest in its proprietary programmes. 2. Asthma • In the United States, there are approximately 20 million asthmatics(1). • An annual economic cost to the US of $16bn (1). • There are 1,900,000 emergency department visits due to asthma per year in the US (1). • The cost of emergency department visits and in-patient care in relation to asthma is $4.1bn(1). • There is evidence that as many as 80% of asthma exacerbations which resulted in emergency department visits can be associated with RV infections (3). • It has been shown that the severest 10% of the asthmatic population take up over 50% of the total cost of the disease(2). Information about common colds and rhinovirus (RV). • Adults get an average of two to four colds per year, mostly between September and May(4). • Young children suffer from an average of six to eight colds per year(4). • Asthmatics contract as many colds as non-asthmatics(5). • Asthmatics have similar upper respiratory tract (nose and throat) symptoms as non-asthmatics(5). • Asthmatics frequently suffer lower respiratory tract (the airways in the lung) infections(5). Xolair(R) the first treatment for severe asthmatics Xolair marketed by Genentech in the US costs some $10,000 per patient per year.Xolair has been shown to reduce the frequency of asthma exacerbations and istargeted at severe asthmatics whose asthma is primarily caused by the allergicpathway. References 1 American Lung Association. Trends in Asthma Morbidity and Mortality. 2005 www.lungusa.org 2 P.J. Barnes, B. Jonsson, J.B. Klim. The Costs of Asthma. Eur Respir J 1996 9, 636-642 3 S. Kling et al, Persistence of Rhinovirus RNA after asthma exacerbations in children. Clin Exp Allergy 2005 May 35 (5) 672-8 4 Cold and Flu Guidelines: The Common Cold www.lungusa.org 5 J.M. Corne et al Frequency, severity and duration of rhinovirus infections in asthmatic and non-asthmatic individuals: a longitudinal cohort study. Lancet 2002 Mar 9; 359 (9309):831-4 This information is provided by RNS The company news service from the London Stock Exchange