Result of pilot med. trial

Futura Medical PLC 21 April 2004 Draft Press Release 21 April 2004 Futura Medical announces successful pilot stage of 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 pilot stage of a clinical trial in healthy female volunteers ('Subjects') at the internationally-renowned Porterbrook Clinic in Sheffield. Four Subjects completed a single-blind, placebo-controlled trial, during which they received placebo as well as three different-strength doses of the compound under development. Two Subjects (50%) demonstrated enhanced blood circulation on exposure to the compound. Of these, one responded to the two highest doses while the second responded to the highest dose. The pattern of these responses mimics exactly the blood flow changes in women during clitoral stimulation and sexual arousal. There were no corresponding responses by any of the Subjects to placebo doses. Application of the formulation to the Subjects was found to be safe and well tolerated. There were no adverse events in any Subject at any dose, nor clinically significant changes in blood pressure, haematology and biochemistry profiles. In accordance with the original study protocol a further six subjects are now being recruited to support these early observations, as well as providing the opportunity to use higher dose levels to further increase response rates without compromising Subject safety or tolerability. James Barder, Chief Executive of Futura, said: 'This pilot study demonstrates that local application of our compound can improve blood flow in a way that mimics the female physiological response during clitoral stimulation and sexual arousal. Increased lubrication caused by the compound could provide a therapeutic intervention for women with certain sexual problems such as low libido and/or poor lubrication. Furthermore, enhanced lubrication resulting from increased blood flow would reduce the risk of condom slippage and breakage during sexual intercourse. '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.' 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: Bankside Peter Curtain / Alex Tweed Tel: +44 (0) 20 7444 4140 mailto:alexandra.tweed@bankside.com www.bankside.com Notes to Editors: 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, a rub-on cream for erectile dysfunction (ED), completed its Phase II study, which demonstrated a good safety profile and efficacy trends. MED2001 is likely to enter Phase III trials later in 2004, prior to a regulatory submission in 2005. A trial to assess the safety of MED2001 in angina patients is underway. Normal medications taken by angina patients prevent the use of available ED treatments such as Viagra(TM), Cialis(TM) and Levitra(TM). 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. The regulatory dossier is scheduled for submission in 2004. An exclusive agreement with SSL International plc, the maker of DurexTM, to distribute the product is expected to be income generating in 2005. FLD500, aimed primarily at female partners of male condom users, will help women maintain lubrication during intercourse, thereby reducing the risk of condom failure. www.futuramedical.co.uk This information is provided by RNS The company news service from the London Stock Exchange
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