Plethora Solutions Holdings Plc Regulatory News (PLE)

30 Sep 2009 07:00



PLETHORA SOLUTIONS HOLDINGS PLC

Clinical Update

Additional supportive positive clinical data from PSD506 studies in incontinence in women and benign prostatic hyperplasia in men

Summary

PSD506 represents the first of a new generation of a drug class known as anti-muscarinics with potential in urinary urge incontinence (UUI) and benign prostatic hyperplasia (BPH).

Newly reported data confirm safety at the clinically effective dose of 20mg which had been identified in a previous study.

New data indicates that PSD 506 should be equally safe in male and female patients and therefore may have the potential to be the first member of the drug class approved for the treatment of males with BPH. 

PSD506 has the potential to produce clinical benefit in the absence of the compliance limiting side effects of dry mouth, gastrointestinal disturbance and dizziness/ confusion, which are characteristic of other members of the drug class.

Plethora Solutions Holdings PLC ("Plethora", AIM: PLE), the specialist developer of products for the treatment and management of urological disorders, has announced results from clinical studies with PSD506 with patients with urinary urge incontinence (UUI) and/or benign prostatic hyperplasia (BPH). 

These studies have shown that PSD506, a potential novel drug treatment for overactive bladder in women also known as UUI, is safe at doses equal to the clinically effective dose of 20mg which had been identified in a previous Plethora study.

PSD506 is a novel drug entity developed for the treatment of UUI in women and potentially UUI and Lower Urinary Tract Symptoms (LUTS) in men. PSD506 represents the first of a new generation of a drug class known as anti-muscarinics and these drugs are the mainstay of the management of UUI. Although members of this drug class can be highly effective, they are poorly tolerated due to the compliance-limiting side effect of dry mouth, which in some cases can result in patients not being able to speak nor swallow. PSD506 is a member of this class but has a different pharmacological profile from existing drugs in this class. PSD506 works by selective and potent antagonism of two receptors important for mediating over-excitability of the human bladder, M2 and M3 muscarinic cholinoceptors. PSD506 has the potential to improve the inhibition of hyperactivity in urological tissues, while sparing common anti-muscarinic side-effects of dry mouth, gastrointestinal disturbance and dizziness/ confusion, which are observed with current therapies in the class. Plethora licensed exclusive rights to PSD506 from F. Hoffmann-La Roche Ltd.

Prior to this study, the optimal clinically effective dose of PSD506 has been determined as 20mg in a study reported by Plethora in 2008. These latest studies show that none of the patients receiving PSD506 reported any serious adverse events and the new data provide further evidence that the drug is well tolerated not only in women but also, for the first time, in men with BPH at doses that could produce clinical benefit. There were no reports of dry mouth in either study. The clinical benefit will now be defined in additional studies.

Dr Mike Wyllie, Plethora CSO commented: "These studies provide additional evidence for the safety of PSD506 in women and for the first time in men with BPH. Particularly pleasing is the fact that little dry mouth has been seen in over 200 volunteers and patients and this provides evidence of a major point of clinical differentiation over marketed anti-muscarinic agents. PSD506 could also become the first anti-muscarinic agent specifically approved for treatment of men with BPH"

UUI is characterized by an unpredictable, frequent and sudden need to urinate, which may or may not result in the leaking or gushing of urine. It is estimated that approximately 7 million women in North America, France, Germany, Italy, Spain and the United Kingdom experience moderate to severe UUI and a further 12 million suffer from moderate to severe mixed incontinence. Anti-muscarinic drugs typically provide first line therapy for this condition. Approximately 45 million men in the USA and Western Europe suffer from BPH which is poorly controlled by existing drugs such as alpha-blockers and 5-alpha-redcutase inhibitors. Existing, marketed anti-muscarinic agents are contra-indicated in BPH.

-Ends-

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About Plethora:

Plethora is focused on the development and marketing of products for the treatment of urological disorders. The Company has products in clinical development for the treatment of overactive bladder (PSD506), stress urinary incontinence (PSD503), interstitial cystitis (PSD597), gynaecological pain (PSD508), erectile dysfunction (PSD510) and premature ejaculation (PSD502). The Company is headquartered in the UK and is listed on the London Stock Exchange (AIM:PLE) 

Further information is available at www.plethorasolutions.co.uk