CeNeS and ERGOMED Report Start of Recruitment for Phase II trial of CNS 5161 in cancer pain.
Cambridge, UK, [10th] September 2007 and Frankfurt, Germany– CeNeS Pharmaceuticals plc (AIM: CEN) (“CeNeS” or “the Company”) and the ERGOMED Group today announced that they have initiated recruitment into a Phase II study of the potential new pain drug CNS 5161. CNS 5161 is being developed under a co-development deal signed in July 2006 between CeNeS and ERGOMED.
The Phase II dose-escalation study is designed to establish the optimal schedule for infusion of CNS 5161 in the management of cancer pain. It will be carried out at a specialist oncology unit in Europe and will assess the safety, efficacy and phamacokinetic profile of CNS 5161 administered intravenously at various doses over 24 hours when added to opioids for the treatment of cancer pain with a neuropathic component.
The aim of the study is to identify the maximum tolerated dose and analgesic efficacy of CNS 5161 in this patient population. The study will also assess any correlation between changes in pain level and the plasma concentrations of CNS 5161. Up to 36 subjects will be enrolled sequentially and receive intravenous infusions of CNS 5161 administered at 4 hour intervals at increasing dose levels. The results of the study are planned to be available in H1 2008.
Pain is an inevitable consequence of most solid cancers. It has been estimated that nearly three million patients in the seven major markets will require treatment for cancer pain annually and that more than 70 per cent. of late stage cancer patients suffer from moderate to severe pain (Source Apex Healthcare). Opioids are commonly used for managing moderate to severe cancer pain, but it has been estimated that around 20 per cent. of patients will experience opioid-refractory pain that has to be treated using alternative therapies.
Commenting on today’s announcement Neil Clark, Chief Executive said, “I am very pleased to report that CeNeS has commenced the first Phase II study under the co-development agreement with Ergomed. Significant numbers of cancer patients are not receiving adequate pain relief from existing pain drugs and this trial will help establish the potential of CNS 5161 to provide an effective alternative in the treatment of late stage cancer pain.”
Miroslav Reljanovic, CEO of the ERGOMED Group added, “We are delighted to be moving into the next stage of our co-development program with CeNeS. CNS 5161 is a product with tremendous potential and we look forward to working with CeNeS to realise its full value.”
For more information please contact:
CeNeS Pharmaceuticals plc
Neil Clark, CEO
Tel: +44 (0)1223 266 466
ERGOMED Group
Dr Miroslav Reljanovic
Tel: +385 (0)1 4628500
JM Finn
Geoff Nash
Tel: +44(0) 207 628 9688
Northbank Communications
Dr Douglas Pretsell
Tel: + 49 (0)89 57 00 18 06
Financial Dynamics
Ben Brewerton/Emma Thompson
Tel: + 44 (0) 207 831 3113
About CeNeS Pharmaceuticals
CeNeS is a biopharmaceutical company specialising in the development and commercialisation of drugs for pain control, sedation and other CNS disorders such as Parkinson’s disease. The company is based in Cambridge, England. For further information visit the CeNeS web site: www.cenes.com
About ERGOMED Group
ERGOMED is a specialised international clinical development company offering contract clinical research and co-development partnerships to biotechnology and pharmaceutical companies worldwide in the fields of neurology, oncology and immunology. Ergomed’s approach to clinical research ensures effective patient recruitment, reducing the time and costs of clinical trials and complementing the drug discovery capabilities of its customers and partners. The Company has a dual business model offering standard clinical trial management contracts and also co-development partnerships to share the risks and rewards of clinical development. Ergomed is headquartered in Frankfurt, Germany, and has offices throughout Europe and in USA. For further information visit www.ergomed-cro.com
Notes to editors
CNS 5161 – for the treatment of neuropathic and cancer pain
Neuropathic pain arises from a range of primary causes (including diseases) that can result in nerve damage. These diseases include cancer, diabetes, shingles and HIV/AIDS. The most common treatments for neuropathic pain include tricyclic anti-depressants and anticonvulsant drugs, though their side effects are problematic and many of these drugs are not licensed for use in the treatment of neuropathic pain.
A body of evidence indicates that the NMDA subtype of neuronal glutamate receptors play a role in the development of neuropathic pain and agents that block these receptors have been shown to reduce neuropathic pain in animals and humans. CNS 5161 is a selective NMDA antagonist that is designed to block the NMDA ion channel involved in the transmission of neuropathic pain. CeNeS has conducted pre-clinical and Phase IIa studies with CNS 5161 which showed that the drug has potential activity against neuropathic pain without dose limiting CNS side effects.
In July 2006, CeNeS and Ergomed announced that they have entered into a revenue sharing and co-development agreement (“the Ergomed Agreement”) whereby the parties intend to collaborate on a comprehensive development programme for CNS 5161. A detailed product plan has been prepared by CeNeS and Ergomed which sets out how the parties will collaborate to assemble Phase II data packages.
The growing number of patients affected by neuropathic pain means that it presents a large market opportunity currently estimated to exceed $2.5 billion annually and expected to exceed $6.7 billion by 2009. Approximately 26 million patients worldwide suffer from some form of neuropathic pain, with over 10 million patients in the United States and 9 million in Europe (Source Espicom).
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