24th Aug 2011 07:00
24 August 2011
LSE: VER
Vernalis Initiates Phase I Trial of V81444 for Parkinson's Disease
Vernalis plc today announces it has dosed the first subjects in a Phase I trial of V81444, its adenosine A2A receptor antagonist programme. A2A receptor antagonists are believed to have advantages over conventional dopaminergic strategies, in that they may be able to help restore motor function in patients with Parkinson's Disease (PD), without the side effects commonly associated with today's treatments.
The study is a combined single and multiple ascending dose safety, tolerability and pharmacokinetic trial and will be conducted in healthy male volunteers. A total of 18 subjects will participate in the single dose phase in two alternating cohorts, allowing six different doses of V81444 to be evaluated. The multiple ascending dose phase will evaluate treatment for 14 days at four different dose levels in a total of 32 subjects. Both the single and multiple dose phases will be placebo controlled, and the dose escalation decisions will be based on the safety and pharmacokinetic data from the previous dose levels. Results from the study are expected in the first half of 2012.
Ian Garland, CEO of Vernalis commented "V81444's progression into Phase I is an important milestone for Vernalis as we continue to study this potentially high value development programme. The A2A target has already been validated in other Parkinson's disease programmes and this Phase I study is the first step in establishing the safety and pharmacokinetic profile of our A2A programme."
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Enquiries:
Vernalis Contacts
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Ian Garland, Chief Executive Officer | +44 (0) 118 989 9360 |
David Mackney, Chief Financial Officer
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Brunswick Group
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Jon Coles | +44 (0) 20 7404 5959 |
Kristin Shine | |
Taylor Rafferty
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Rob Newman | +44 (0) 20 7614 2900 |
Faisal Kanth |
Notes to Editors
About Vernalis
Vernalis is a revenue generating development stage pharmaceutical company with significant expertise in taking promising product candidates along a commercially-focused path to market. The Group has one marketed product, frovatriptan for the acute treatment of migraine, and eight candidates in development, seven of which are designated priority programmes. Four of these priority development programmes are currently unpartnered and three are partnered. Pipeline programmes are derived from both our own research activities where we have significant expertise in fragment and structure based drug discovery, as well as from collaborations. Our technologies, capabilities and products are endorsed by collaborations with Endo, GSK, Lundbeck, Menarini, Novartis and Servier.
Product | Indication | Pre-Clinical | Phase I | Phase II | Phase III | Marketed | Marketing Rights |
PRIORITY PROGRAMMES | |||||||
CNS Programmes | |||||||
Frovatriptan | Acute Migraine | X | Menarini & Endo Pharma | ||||
V158866 | Pain | X | Worldwide | ||||
V81444 | Parkinson's Disease | X | Worldwide | ||||
Oncology Programmes | |||||||
AUY922 | Cancer | X | Novartis | ||||
CHR2797 | Cancer | X | Chroma Therapeutics | ||||
HSP990 | Cancer | X | Novartis | ||||
V158411 | Cancer | X | Worldwide | ||||
Other Therapeutic Areas | |||||||
V85546 | Inflammatory Disease | X | Worldwide | ||||
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LEGACY PROGRAMMES | |||||||
RPL554 | Asthma/ Allergic Rhinitis | X | Verona Pharma |
For further information about Vernalis, please visit www.vernalis.com
Vernalis Forward-Looking Statement
This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events including the clinical development and regulatory clearance of the Company's products, the Company's ability to find partners for the development and commercialisation of its products, as well as the Company's future capital raising activities. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, the uncertainties related to the regulatory process, the ability of the Company to identify and agree beneficial terms with suitable partners for the commercialisation and/or development of its products, as well as the achievement of expected synergies from such transactions, the acceptance of frovatriptan and other products by consumers and medical professionals, the successful integration of completed mergers and acquisitions and achievement of expected synergies from such transactions, and the ability of the Company to identify and consummate suitable strategic and business combination transactions.
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