Futura Medical Regulatory News (FUM)

7 Nov 2005 07:00

Futura Medical PLC07 November 2005 For Immediate Release 7 November 2005 Futura Medical plc Announces preliminary results from MED2003/4/5 pharmacokinetic 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 first of two clinical trials in healthy male volunteers(Subjects) to evaluate three novel formulations of its topical gel for thetreatment of erectile dysfunction (ED). Sixteen Subjects have completed an escalating dose study in which they receivedsix different gels applied directly to the penis over a three week periodthereby allowing a suitable period of time between each different gelapplication. All six gels contained the compound glyceryl trinitrate (GTN)within three gel formulations, MED2003, MED2004 and MED2005, which have beendeveloped to deliver GTN into the penile tissues at different rates. An excellent safety profile was achieved with a dose-related response in termsof incidence and severity of adverse events based on the strength and rate ofrelease of GTN from the gels. The adverse events reported were predominantlymild headaches which were pharmacologically predictable, resolved spontaneouslyand did not require treatment. No serious adverse events were recorded and nofalls in blood pressure seen. Levels of GTN within the Subjects' blood plasmaindicate a highly favourable pharmacokinetic profile characterised by rapidabsorption and elimination of the compound. In addition the absorption profileis consistent with the intended use of the product in the treatment of erectiledysfunction, suggesting a rapid onset of action, within a few minutes of productapplication, and no prolonged side effects. James Barder, Chief Executive of Futura, said: "We are greatly encouraged bythese preliminary results of this pharmacokinetic study. We firmly believe wehave identified the correct dose and formulation to deliver a GTN level that iswell tolerated and safe. A second placebo-controlled study investigating thepharmacodynamic events of these new formulations has recently completed and weexpect to able to release the results of this study towards the end of November." 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 DurexTM 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. Further technical data on the pharmacokinetic study is available upon request. 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