Appointment of CRO for MED2002 Clinical Study
15 December 2014
Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to announce that it has appointed a clinical research organisation (CRO) to conduct its forthcoming clinical efficacy study on MED2002, the Company's topical gel for the treatment of erectile dysfunction (ED).
The study, which will take place in the UK, is expected to commence in Q1 2015 and report in Q4 2015. The CRO for this study is the same CRO that conducted the successful pivotal study for CSD500, the Company's novel condom which launched several months ago and shares the same active ingredient as MED2002. In contrast to CSD500, MED2002 is expected initially to be a prescription-only product.
Approximately 140 patients with ED will participate in the study, which will be a randomised, placebo-controlled, double blind, home use, cross-over design. The primary outcome of the study is statistically significant efficacy. David Ralph, Past-President of the British Society for Sexual Medicine and currently Vice President of the Sexual Dysfunction Association and President of the European Society for Sexual Medicine and a recognised key opinion leader, is advising the Company on the design of the study and development of MED2002.
David Ralph BSc MS FRCS (Urol), Consultant Urologist and Honorary Senior Lecturer at University College London commented: "A significant number of ED sufferers cannot be prescribed PDE5 inhibitors as they are contra-indicated with other medications that they take. In addition there is strong patient interest in effective alternative ED treatments with a rapid speed of onset. This makes MED2002 a potentially interesting product."
James Barder, Futura's Chief Executive, said: "MED2002 has the same active ingredient as CSD500 and shares the same mechanism of action of improving blood flow to the penis. Futura holds worldwide rights to MED2002, so the successful demonstration of clinically statistical efficacy in this clinical study forms an important part of our out-licensing strategy."
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Notes to Editors:
Futura Medical plc
Futura Medical is a pharmaceutical group that develops innovative products for consumer healthcare. The Company is developing a portfolio of products and its strategy is to license their manufacture and distribution to major pharmaceutical and healthcare groups. Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange.