Research Update

Futura Medical PLC 15 November 2004 Press Release 15 November 2004 Futura Medical announces preliminary results from FLD500 study Futura Medical plc ('Futura'), the AIM-quoted pharmaceutical drug and medical device group that develops innovative products for the sexual healthcare market, announces the completion of the clinical trial in healthy female volunteers (' Subjects') at the internationally renowned Porterbrook Clinic in Sheffield, UK. Ten Subjects completed a single-blind, placebo-controlled, phase I trial. Four Subjects received placebo and three different lower-strength doses of Glyceryl Trinitrate ('GTN'), whereas the remaining six Subjects received placebo and three different higher-strength doses of GTN. Application of the compound to the Subjects was found to be safe and well tolerated at the lower-strength doses, with no adverse events experienced during the twelve exposures. Subjects receiving the higher-strength doses reported dose-related adverse events, predominately headaches, ranging from mild to severe in intensity. No clinically significant changes in blood pressure, haematology or biochemistry profiles were seen in any Subjects at any of the dose levels. Efficacy was assessed by monitoring vaginal microcirculation using photoplethysmography. Positive responses were more frequent in the group receiving the lower-strength doses, where the compound was also considered safe and well tolerated. The pattern of changes observed mimic the blood flow changes seen in women during clitoral stimulation and sexual arousal. These preliminary results will allow Futura to select the preferred doses from the lower-strength group for pivotal studies. James Barder, Chief Executive of Futura, said: 'We are encouraged by these preliminary results of this pilot study for FLD500. We will be discussing them with our potential distribution partner in the near future before moving on to conducting a pivotal study in 2005.' 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: Abchurch Peter Curtain / Alex Tweed Tel: +44 (0) 20 7398 7700 mailto: alex.tweed@abchurch-group.com www.abchurch-group.com Notes to Editors: Futura Medical plc Futura Medical ('Futura' or 'the Company') 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. Several agreements have been signed. 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 June 2003 the Company's first product, MED2001 (now reformulated as MED2002), a rub-on cream for erectile dysfunction ('ED'), completed its Phase II study, which demonstrated a good safety profile and efficacy trends. MED2002 is currently undergoing a final pharmacokinetic and dose evaluation study prior to entering Phase III trials in Q2 2005. A trial to assess the safety of MED2002 in angina patients has already been successfully completed. Subject to regulatory approval the Company intends to recruit men suffering from ED with mild to moderate angina into the Phase III trial. Normal medications taken by angina patients prevent the use of available ED treatments such as ViagraTM, CialisTM and LevitraTM. The Company's second product is CSD500, a latex condom incorporating within its teat a gel to help healthy men maintain an erection throughout intercourse, so reducing the likelihood of condom slippage. An exclusive agreement with SSL International plc, the maker of DurexTM, to distribute the product has been signed. FLD500, aimed primarily at female partners of male condom users, will help women maintain lubrication during intercourse, thereby reducing the risk of condom failure. It is estimated that two out of every five women experience some form of sexual dysfunction during their lives and that approximately 2% of condoms slip off during intercourse increasing the risk of unwanted pregnancies and the transference of sexual transmitted infections. www.futuramedical.co.uk This information is provided by RNS The company news service from the London Stock Exchange
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