31st Oct 2007 07:01
Vectura Group plc31 October 2007 Vectura announces successful outcome of second Phase II clinical study from Parkinson's disease programme Chippenham, UK - 31 October 2007: Vectura Group plc ("Vectura"; LSE: VEC) todayannounces positive data from a Phase II clinical study for its product, VR040,for the treatment of "off" episodes, debilitating periods of complete or partialimmobility, in patients with Parkinson's disease. VR040 is Vectura'sproprietary formulation of apomorphine, delivered to the bloodstream by oralinhalation through the lungs using the Company's proprietary dry powderinhalation (DPI) technology. The study demonstrated: • Statistically significant improvement in the primary endpoint of meanchange in Unified Parkinson Disease Rating Scale III (UPDRS III) relative tothat seen with placebo (p=0.016) • High restoration of mobility, allowing 81% of patients to achieveresponses essentially the same as those achieved with their usual levodopa dose • Rapid onset of action; the majority of patients achieved conversionswithin 10 minutes of inhaling apomorphine. Some patients reported conversion asquickly as 2 minutes after taking their medication • Durability of response, with a mean duration of 75 minutes • Excellent tolerability with only 5 of 32 patients reporting a total of7 treatment-related adverse events; no reports of treatment-related serious orsevere adverse events and no patient withdrawals resulting from safety concerns The randomised, double-blind, placebo-controlled study evaluated the safety andefficacy of four different VR040 fine particle doses up to 3.2 mg. Forty-sevenpatients, diagnosed with idiopathic Parkinson's disease, were randomised toreceive either placebo or active treatment. On visiting the clinic, a patient'sconventional treatment was stopped temporarily and an "off" episode induced.Each patient then received increasing VR040 doses or placebo equivalent, until atherapeutic response approximately equivalent to that measured with their usuallevodopa dose was recorded. Dr Donald Grosset, BSc (Hons), MBChB, MD, Consultant Neurologist in theInstitute of Neurological Sciences, Southern General Hospital, Glasgow, UK andPrincipal Investigator of the study, commented: "The data support the clinicaleffectiveness of VR040 in Parkinson's disease. This new, non-invasive way ofdelivering apomorphine quickly and efficiently to the bloodstream translatesinto a very rapid onset of action. This, together with the lack of sideeffects, means VR040 should provide benefit to Parkinson's disease patients astheir disease progresses." Dr Chris Blackwell, Chief Executive of Vectura, added: "The results of thisstudy confirm our original enthusiasm for VR040's potential. VR040 represents abreakthrough in providing a rapid onset of action, which is also durable.Importantly, our novel delivery route, via inhalation, also offers patients animproved alternative to the currently available formulations of apomorphine.The next stage in VR040 clinical development will focus on determining optimaltitrated dosing in an 'at home' setting." - Ends - Enquiries: Vectura Group plc +44 (0)1249 667 600Dr Chris BlackwellAnne HylandJulia Wilson Financial Dynamics +44 (0)20 7831 3113David YatesSanjeev Pandya Notes for Editors: About Parkinson's disease It is estimated that approximately 1 million people in Europe and 1.5 millionpeople in the US have PD. Approximately 10% of these experience severe on/offmotor fluctuations which require apomorphine treatment. PD is a progressiveneurological disorder that leads to the loss of dopamine containing neurons inthe basal ganglia of the brain. People with PD often experience trembling,muscle rigidity, and difficulty walking. As the disease progresses, therapeuticcontrol diminishes and patients experience motor complications ("off" episodes)which become more frequent, and severe, and are disabling and often of suddenonset. VR040 aims to provide rapid, non-invasive relief from such symptoms. About UPDRS The Unified Parkinson Disease Rating Scale (UPDRS) rates a patient across 31separate items, each with a score of 0-4. The rating scale covers three areas:mentation, behaviour and mood (4 items); activities of daily living (13 items);and motor examination (14 items). The latter component, UPDRS III, is routinelyemployed across clinical studies to measure changes in motor function as aresult of treatment administration. About the first Phase II "proof of concept" VR040 study Results from the first VR040 clinical study which was a proof of concept studywere published on 8 August 2006. The study evaluated six actual fine particledoses (170(micro)g, 255 (micro)g, 435 (micro)g, 653 (micro)g, 710 (micro)g, 1065(micro)g) and placebo in 24 PD patients who experience "off" episodes. Whilstthe study was not powered for meaningful statistical comparisons, five patientsconverted to a full "on" state having inhaled VR040, compared with one patientfollowing inhalation of placebo. About Vectura Vectura is a pulmonary drug development company focused principally on thedevelopment of a range of inhaled therapies for the treatment of respiratory andneurological diseases. Vectura develops products to treat respiratory diseases such asthma, COPD andcystic fibrosis. The respiratory market is forecast to achieve sales of $32billion by 2011. Vectura also develops products where optimised delivery via the lungs into theblood stream can provide significant benefits, such as a rapid onset of action,improved efficacy and improved tolerability compared with current therapies. Vectura has eight marketed products and a portfolio of drugs in clinical andpre-clinical development, some of which have been licensed to majorpharmaceutical companies. The Company also seeks to develop certain programmesfurther through development to optimise value at a later licensing stage.Vectura also offers its formulation and inhalation technologies to otherpharmaceutical companies on a licensing basis where this complements Vectura'sbusiness strategy. Vectura has development collaborations with a broad range of pharmaceuticalcompanies including Boehringer Ingelheim, Novartis, and Chiesi. The acquisitionof Innovata in January 2007 brought established alliances with a number ofadditional companies, such as Baxter, GSK, Merck Generics (part of Mylan Inc),UCB and Otsuka as well providing revenue streams, complementary products andcritical mass. For further information, please visit Vectura's website at www.vectura.com Vectura Forward Looking Statement This press release contains "forward-looking statements," including statementsabout the discovery, development and commercialisation of products. Variousrisks may cause Vectura's actual results to differ materially from thoseexpressed or implied by the forward-looking statements, including adverseresults in clinical development programs; failure to obtain patent protectionfor discoveries; commercial limitations imposed by patents owned or controlledby third parties; dependence upon strategic alliance partners to develop andcommercialise products and services; difficulties or delays in obtainingregulatory approvals to market products and services resulting from developmentefforts; the requirement for substantial funding to conduct research anddevelopment and to expand commercialisation activities; and product initiativesby competitors. As a result of these factors, prospective investors arecautioned not to rely on any forward-looking statement. We disclaim anyintention or obligation to update or revise any forward-looking statements,whether as a result of new information, future events or otherwise. 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