8th Aug 2006 07:01
Vectura Group PLC08 August 2006 VECTURA ANNOUNCES SUCCESSFUL OUTCOME OF PHASE II STUDY ON INHALED PARKINSON'S DISEASE PRODUCT - VR040 Chippenham, UK - 8 August, 2006: Vectura Group plc (LSE: VEC) ("Vectura") todayannounces the successful outcome of a Phase II "proof-of concept" clinical studyfor its product, VR040, for the treatment of induced "off" periods in patientswith Parkinson's disease (PD). The study demonstrated that VR040 was safe, well tolerated and successfullyrecovered patients from an induced "off" episode with a rapid onset of action,which was also durable. VR040 is Vectura's proprietary formulation ofapomorphine, delivered by oral inhalation to the lungs using Vectura'sAspirair(R) dry powder inhaler (DPI). PD is a progressive neurological disorder that leads to the loss of dopaminecontaining neurons in the basal ganglia of the brain. People with PD oftenexperience trembling, muscle rigidity, and difficulty walking. As the diseaseprogresses, therapeutic control diminishes and patients experience motorcomplications ("off" episodes) which become more frequent, and severe, and aredisabling and often of sudden onset. VR040 aims to provide rapid, non-invasiverelief from such symptoms. The randomised, double-blind, placebo-controlled, four parallel group, ascendingdose study was designed to assess the safety and tolerability profile of VR040.Preliminary pharmacokinetic (PK) analysis and an assessment of efficacy werealso undertaken. The study evaluated six fine particle doses (200 micrograms, 300 micrograms, 500micrograms, 750 micrograms, 800 micrograms and 1,200 micrograms) and placebo in24 idiopathic PD patients who experience "off" episodes. Each patient receivedone or two doses. On visiting the clinic, a patient's conventional PD treatmentwas withdrawn and an "off" episode induced. Safety and efficacy assessments wereconducted once a patient confirmed existence of "off" status and were continuedpost-administration of randomised study treatment. Recovery from "off" status was determined by patient self-assessment of diseasestate with the time to onset of effect and duration of effect recorded. Safetywas determined via vital signs, lung function, volunteered adverse events (AE)and electrocardiograph (ECG) measurements with blood samples collected formeasurement of plasma apomorphine concentration and subsequent PK analysis. No serious or severe adverse events were reported at any dose and no patientswithdrew from the study. The profile of adverse events for all treatments,including placebo, was similar with no reports of hypotension (low bloodpressure) or syncope (fainting). Pharmacokinetic analysis confirmed that maximum apomorphine plasmaconcentrations were measured 1-3 minutes after doses were inhaled. Whilst the study was not powered for meaningful statistical comparisons,apomorphine-induced conversion from an "off" state was observed in 10 out of 18patients. The median onset of therapeutic effect in responders was 10 minutes(and as rapid as 4 minutes) after inhalation of apomorphine, the effect lastingfor up to 60 minutes, with a median duration of 25 minutes. Five patientsconverted to a full "on" state having inhaled VR040, compared with one patientfollowing inhalation of placebo. Dr Chris Blackwell, Chief Executive of Vectura, said: "This study has demonstrated that VR040 can provide rapid relief from "off"episodes for patients with Parkinson's disease, within minutes of inhalation.This bodes well for future clinical development, which will now focus ondetermining optimal titrated doses of VR040. The funds raised in our recentshare placing provide us with the opportunity to generate significant value fromVR040 as we proceed through these latter stages of development." Dr Donald Grosset, BSc (Hons), MBChB, MD, Consultant Neurologist in theInstitute of Neurological Sciences, Southern General Hospital, Glasgow andPrincipal Investigator of the study, commented: "This study shows that high plasma levels can be achieved very quickly withVR040, which translate into a very quick onset of benefit for patients with PDwho have motor fluctuations in the more advanced stages of their condition." Enquiries: Vectura Group plc Tel+ 44(0) 1249 667700Chris Blackwell, Chief ExecutiveAnne Hyland, CFO Financial Dynamics Tel: +44(0) 207 8313113David Yates/Sarah MacLeod/John Gilbert Notes for Editors: About Parkinson's Disease ("PD") It is estimated that approximately 1 million people in Europe and 1.5m people inthe US have PD approximately 10% of these experience sever on/off motorfluctuations which do not respond to other therapies apart from apomorphine. About Vectura Vectura's principal focus is the development of a range of inhaled drugs for thetreatment both of lung diseases and other conditions where optimised deliveryvia the lungs can provide significant benefits, such as a rapid onset of action,improved efficacy and improved tolerability compared with current therapies. Vectura's products combine its proprietary, innovative, pulmonary formulationand device technologies (Aspirair(R) GyroHaler(R) and PowderHale(R)) withexisting, off-patent drugs either for use in new indications or to provideinhalation as an improved route of administration. Using drugs that have alreadybeen approved in some form in at least one major pharmaceutical market lowersthe risk of product development failure compared to new chemical entities,Vectura is able to secure patent protection for its portfolio by identifying newindications for off-patent compounds and applying the Company's proprietarydelivery technologies to create new methods of administration. The Company hasdevelopment collaborations with a number of companies, including BoehringerIngelheim, Novartis, GSK and Chiesi and an un-named leading internationalpharmaceutical company. For further information, please visit Vectura's website at www.vectura.com. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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