Study Results

Futura Medical PLC 21 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 group that develops innovative products for the sexual healthcare market, announces the completion of the second of two clinical trials in healthy male volunteers (Subjects) to evaluate three novel formulations of its topical gel for the treatment of erectile dysfunction (ED). Fifteen healthy males have completed a placebo controlled, double-blind, randomised study. Each Subject received four different doses of glyceryl trinitrate (GTN) in gels that were applied directly to the penis. The gels have been designed to deliver GTN into the penile tissues more efficiently than previous formulations. As with the initial pharmacokinetic study, the results of which were announced on 7 November 2005, an excellent safety profile was observed. Dose-dependent side effects, which were predominantly mild headaches resolving without the need for treatment, were seen in fewer than 10% of all dosing events. No serious adverse events were recorded and no falls in blood pressure occurred in any of the subjects at any GTN dose. As with the pharmacokinetic study, GTN doses up to 0.25mg were found to be safe and well tolerated. The effects of GTN on penile blood flow were assessed during this study using Doppler ultrasound technology. Despite the lack of sexual stimulation, many Subjects displayed penile blood flow changes following GTN dosing which were consistent with those seen during sexual arousal. In particular, the rate of blood flow into the penis, as recorded by the Peak Systolic Velocity (PSV), demonstrated increases in most of the Subjects on application of drug relative to baseline and compared with placebo. For example, with the preferred formulation approximately 70% of Subjects showed a greater increase in PSV relative to baseline compared with placebo, an outcome that was statistically significant. Dr Paul Sidhu, a consultant radiologist at King's College Hospital, London, and one of the leading experts in penile Doppler ultrasound, confirmed that the changes recorded by Doppler ultrasound after exposure to the gels were consistent with those seen during sexual arousal. He also felt this was an encouraging indicator of the potential efficacy of the gels for the treatment of erectile dysfunction which will need to be verified by the Phase III clinical programme. James Barder, Chief Executive of Futura, said: 'These results are excellent. When considered with the recent pharmacokinetic results we believe that they provide an excellent platform for our Phase III programme. Futura is firmly on track to developing the world's first 'non-prescription' treatment for erectile dysfunction.' For further information: Futura Medical plc James Barder, Chief Executive Tel: +44 (0) 1483 845 670 mail to: james.barder@futuramedical.co.uk www.futuramedical.co.uk Media enquiries: Buchanan Communications Mark 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 group developing innovative products for sexual health. The Company is developing a portfolio of products with the intention of licensing their manufacture and distribution to major pharmaceutical and healthcare groups. Exclusive worldwide distribution agreements have already been signed in respect of Futura's two condom safety products, CSD500 and FLD500, with SSL International plc, the makers of Durex(TM) condoms. Futura's primary focus is on Over the Counter (OTC) products with particular appeal to men and women who are reluctant to discuss potentially embarrassing sexual matters with their doctors. In March 2005 Futura announced it had entered into exclusive discussions until 31st December 2005 with a major global pharmaceutical group on a proposed agreement 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 certain development work on MED2002 to be completed with a view to entering into a potential 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
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