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 programme with CeNeS. CNS 5161 is a compound with tremendous potential and we look forward to working with CeNeS to realise its full value."
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