Vectura announces positive Phase II data for VR496 in cystic fibrosis.
M2 PHARMA-March 25, 2011-Vectura announces positive Phase II data for VR496 in cystic fibrosis(C)2011 M2 COMMUNICATIONS
25 March 2011 - UK-based Vectura Group plc (LON: VEC) today announced positive data from a Phase II clinical study for its orally inhaled product, VR496, a potentially multi-modal treatment for respiratory symptoms associated with airway disorders such as cystic fibrosis (CF).
Seventy-seven CF patients with a median age of 23 years were randomised, double-blind, to placebo or one of three active dose groups. Study treatment was administered twice-daily at home for a period of four weeks. Subjects with established lung inflammation and impaired sputum clearance were eligible for enrolment. Patients with a history of significant haemoptysis (coughing up blood) or unstable disease were excluded.
VR496 was found to be safe and well tolerated with over 90% of patients successfully completing the study. Dosing compliance was high, with 91% of prescribed study treatment administered. Anti-inflammatory activity was demonstrated via reductions, from Baseline to Week 4, in induced sputum neutrophil elastase and total cell counts when compared to placebo. Active treatment also resulted in clearer and thinner sputum that was easier to clear from the airways compared with placebo.
VR496 is Vectura's proprietary formulation of dry powder heparin sodium and has been designated orphan drug status by the European Medicines Agency (EMA) and Food and Drug Administration (FDA).
Chris Blackwell, chief executive of Vectura, said that this study confirms the potential therapeutic benefit of VR496 in a variety of airway disorders and justifies further clinical evaluation.
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|Article Type:||Clinical report|
|Date:||Mar 25, 2011|
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