Futura Medical Regulatory News (FUM)

21 Nov 2005 07:02

Futura Medical PLC21 November 2005 For immediate release 21 November 2005 Futura Medical plc Announces preliminary results from MED2003/5 pharmacodynamic study Futura Medical plc (AIM: FUM), the pharmaceutical drug and medical device groupthat develops innovative products for the sexual healthcare market, announcesthe completion of the second of two clinical trials in healthy male volunteers(Subjects) to evaluate three novel formulations of its topical gel for thetreatment of erectile dysfunction (ED). Fifteen healthy males have completed a placebo controlled, double-blind,randomised study. Each Subject received four different doses of glyceryltrinitrate (GTN) in gels that were applied directly to the penis. The gels havebeen designed to deliver GTN into the penile tissues more efficiently thanprevious formulations. As with the initial pharmacokinetic study, the results of which were announcedon 7 November 2005, an excellent safety profile was observed. Dose-dependentside effects, which were predominantly mild headaches resolving without the needfor treatment, were seen in fewer than 10% of all dosing events. No seriousadverse events were recorded and no falls in blood pressure occurred in any ofthe subjects at any GTN dose. As with the pharmacokinetic study, GTN doses upto 0.25mg were found to be safe and well tolerated. The effects of GTN on penile blood flow were assessed during this study usingDoppler ultrasound technology. Despite the lack of sexual stimulation, manySubjects displayed penile blood flow changes following GTN dosing which wereconsistent with those seen during sexual arousal. In particular, the rate ofblood flow into the penis, as recorded by the Peak Systolic Velocity (PSV),demonstrated increases in most of the Subjects on application of drug relativeto baseline and compared with placebo. For example, with the preferredformulation approximately 70% of Subjects showed a greater increase in PSVrelative to baseline compared with placebo, an outcome that was statisticallysignificant. Dr Paul Sidhu, a consultant radiologist at King's College Hospital, London, andone of the leading experts in penile Doppler ultrasound, confirmed that thechanges recorded by Doppler ultrasound after exposure to the gels wereconsistent with those seen during sexual arousal. He also felt this was anencouraging indicator of the potential efficacy of the gels for the treatment oferectile dysfunction which will need to be verified by the Phase III clinicalprogramme. James Barder, Chief Executive of Futura, said: "These results are excellent.When considered with the recent pharmacokinetic results we believe that theyprovide an excellent platform for our Phase III programme. Futura is firmly ontrack to developing the world's first 'non-prescription' treatment for erectiledysfunction." For further information:Futura Medical plcJames Barder, Chief Executive Tel: +44 (0) 1483 845 670mail to: james.barder@futuramedical.co.uk www.futuramedical.co.uk Media enquiries:Buchanan CommunicationsMark Court / Tim Anderson / Rebecca Dietrich Tel: +44 (0) 20 7466 5000 Notes to Editors: Futura Medical plc Futura Medical is an AIM-listed pharmaceutical drug and medical device groupdeveloping innovative products for sexual health. The Company is developing aportfolio of products with the intention of licensing their manufacture anddistribution to major pharmaceutical and healthcare groups. Exclusiveworldwide distribution agreements have already been signed in respect ofFutura's two condom safety products, CSD500 and FLD500, with SSL Internationalplc, the makers of Durex(TM) condoms. Futura's primary focus is on Over the Counter (OTC) products with particularappeal to men and women who are reluctant to discuss potentially embarrassingsexual matters with their doctors. In March 2005 Futura announced it had entered into exclusive discussions until31st December 2005 with a major global pharmaceutical group on a proposedagreement for the worldwide development and marketing of MED2002 (MED2003,MED2004 & MED2005 are revised formulations of MED2002). This was to allow time for discussions, joint co-operation and certaindevelopment work on MED2002 to be completed with a view to entering into apotential global distribution agreement. Phase III trials are scheduled to commence in 2006. For further information please visit: www.futuramedical.co.uk This information is provided by RNS The company news service from the London Stock Exchange