Vernalis Starts Phase IIa Trial of V3381 in Diabetic Neuropathic Pain
03 August 2006
Vernalis plc (LSE: VER, Nasdaq: VNLS) today announced that it has commenced enrolment into a Phase IIa trial of V3381 in patients with neuropathic pain resulting from long-standing diabetes. V3381 is the Company’s novel drug candidate that is believed to have dual mechanisms of action targeting both the central and peripheral nervous systems and is a programme where Vernalis has world-wide rights.
The randomised, double-blind, crossover Phase IIa study is designed to assess safety, pharmacokinetics and preliminary efficacy of repeat dosing of V3381, with efficacy being assessed on a numerical point pain rating scale recorded using daily diaries. The trial is being conducted in the United States and Canada , will include approximately 30 patients and is planned to complete in 12 months.
V3381 was originally licensed from Chiesi and has previously undergone evaluation in pre-clinical and Phase I clinical studies, including two proof-of-concept studies in a human model of neuropathic pain.
“Neuropathic pain causes enormous suffering and we are hopeful that V3381 may ultimately prove to be an effective treatment for this challenging condition,” said Simon Sturge , CEO of Vernalis. "We are building our franchise in pain management and are pleased that we have progressed V3381 to the next stage in its development.”
Neuropathic pain resulting from diabetes is a poorly treated condition that affects 4 million patients in the US and Europe . According to the National Institute of Diabetes & Digestive & Kidney Diseases, approximately half of those with diabetes develop some form of neuropathy, highlighting the growing need for drug treatment in this condition. The global trends towards obesity are furthering the incidence of diabetes and hence the problem of neuropathic pain is on the increase.
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Enquiries:
| Vernalis plc | +44 (0) 118 977 3133 |
| Simon Sturge, Chief Executive Officer | |
| John Hutchison, Development Director | |
| Julia Wilson, Head of Corporate Communications | |
| Brunswick Group | +44 (0) 20 7404 5959 |
| Jon Coles | |
| Alex Tweed |
Notes to Editors
Neuropathic pain is a chronic form of pain related to damage to
nerves and their signalling processes, and unlike other forms of
pain, is generally non-responsive to current analgesics, does not
diminish over time and can increase in both intensity and area.
This type of pain occurs in later stages of diabetes, post-herpetic
neuralgia (shingles), side effects of chemotherapy, trigeminal
(facial) neuralgia, HIV infection, spinal cord injuries and other
nerve injuries (eg. amputation).
About Vernalis
Vernalis is a speciality bio-pharmaceutical company focused on
products marketed to specialist neurologists. The company has two
marketed products, Frova® and Apokyn®, and a development
pipeline focused on neurology and central nervous system disorders.
The company has seven products in clinical development and
collaborations with leading, global pharmaceutical companies
including Novartis, Biogen Idec, Serono and Chiesi:
| Product | Indication | Phase I | Phase II | Phase III | Registration | Market | Marketing Rights |
| Apokyn® | Parkinson’s Disease | X | North America | ||||
| Frova® | Migraine | X | US Co-promotion Endo (EU – royalties) | ||||
| Frova® | Menstrual Migraine Prevention | X | US Co-promotion Endo (EU – royalties) | ||||
| V1512 | Parkinson’s Disease | X | World Wide (excl. Italy) | ||||
| V10153 | Thrombotic Disorders | X | World Wide | ||||
| V1003 | Acute Pain | X | US Profit share Option Reckitt Benckiser | ||||
| V3381 | Neuropathic Pain | X | World Wide | ||||
| V2006 | Parkinson’s Disease | X | US Co-promotion Biogen Idec | ||||
| MMPI | Multiple Sclerosis | X | None - royalty (Serono) |
Vernalis has established a US commercial operation to promote Apokyn ® and co-promote Frova ® alongside its North American licensing partner, Endo Pharmaceuticals, propelling the company towards its goal of becoming a sustainable, self-funding, R&D-driven, speciality bio-pharmaceutical company. For further information about Vernalis, please visit www.vernalis.com .
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 Frova® and Apokyn® 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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