28th Jun 2006 07:41
Vectura Group PLC28 June 2006 VECTURA ANNOUNCES SUCCESSFUL OUTCOME OF PHASE IIb CLINICAL STUDY OF INHALED ERECTILE DYSFUNCTION PRODUCT Embargoed until 7.30am 28 June 2006 Chippenham, UK - 28 June, 2006: Vectura Group plc (LSE: VEC) ("Vectura") todayannounces the successful outcome of a Phase IIb clinical study for its product,VR004, for the treatment of Erectile Dysfunction (ED). The study demonstratedthat VR004 improved erectile performance with a rapid onset of action that wasboth durable and well tolerated. VR004 is Vectura's proprietary formulation of apomorphine, delivered by oralinhalation to the lungs using Vectura's Aspirair(R) dry powder inhaler (DPI). The study is the first of two double-blind, placebo-controlled trials designedto assess the safety and efficacy of VR004. The study evaluated three fineparticle doses (150 (micro)g, 250 (micro)g and 300 (micro)g) and placebo inpatients with mild, moderate or severe ED. Following a four week "notreatment" run-in period, patients were randomised to either placebo or VR004.On successful completion of an orthostatic challenge (quick standing and sittingmanoeuvres to expose intolerance to vasodilation), patients were allowed homewith study treatment for a period of 12 weeks. The assessment of efficacy used the Sexual Encounter Profile (SEP) questions 2and 3. SEP 2 is a measure of the ability of a patient to achieve vaginalpenetration. SEP 3 assesses the ability of a patient to maintain an erectionsuitable for successful intercourse. The study primary endpoints measured changes in SEP 2 and SEP 3 frompre-treatment baseline to the last 4 weeks of study treatment. In addition,patients were requested to record the time to onset and the duration oferection. The following table shows the percentage of positive answers to SEP 2 and SEP 3in the last 4 weeks of treatment, and the change in positive answers to SEP 2and SEP 3 from baseline to the last 4 weeks of treatment, for the 138 patientswho received at least 6 doses of VR004 "at home": 150 250 300 Placebo (micro)g (micro)g (micro)gPercentage of "positive" answers to SEP 2 in last 4 weeks 69% 87% 79% 60%of treatmentPercentage of "positive" answers to SEP 3 in last 4 weeks 46% 60% 62% 38%of treatmentChange in "positive" answers to SEP 2 from baseline to last 8%* 30%* 25%* -4%4 weeks of treatmentChange in "positive" answers to SEP 3 from baseline to last 14% 26%* 28%* 6%4 weeks of treatment *pRelated Shares:
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