CeNeS and ERGOMED Report Start of Recruitment for Phase II trial of CNS 5161 in cancer pain

CeNeS Pharmaceuticals plc (AIM: CEN) 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 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

Most Popular Now

Pfizer receives positive FDA Advisory Committee vo…

Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that avail...

Engineered bacteria find tumors, then alert the au…

Combining discoveries in cancer immunology with sophisticated genetic engineering, Columbia University researchers have created a sort of "bacterial suicide squad" that ...

First nasal monoclonal antibody treatment for COVI…

A pilot trial by investigators from Brigham and Women's Hospital, a founding member of the Mass General Brigham healthcare system, tested the nasal administration of the ...

US FDA Advisory Committee votes to support effecti…

GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the avail...

"Semantic similarity" leads to novel dru…

The words that researchers use to describe their results can be harnessed to discover potential new treatments for Parkinson's disease, according to a new study published...

Tumour cells' response to chemotherapy is driven b…

Cancer cells have an innate randomness in their ability to respond to chemotherapy, which is another tool in their arsenal of resisting treatment, new research led by the...

Pfizer invests $43 billion to battle cancer

Pfizer Inc. (NYSE: PFE) and Seagen Inc. (Nasdaq: SGEN) today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Seagen, a...

Pfizer's ZAVZPRET™ (zavegepant) migraine nasal spr…

Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has approved ZAVZPRET™ (zavegepant), the first and only calcitonin gene-related peptid...

Gene and cell therapies to combat pancreatic cance…

Pancreatic cancer is an incurable form of cancer, and gene therapies are currently in clinical testing to treat this deadly disease. A comprehensive review of the gene an...

Scientists reveal a potential new approach to trea…

Scientists at the National Institutes of Health and Massachusetts General Hospital in Boston have uncovered a potential new approach against liver cancer that could lead ...

Normalizing tumor blood vessels may improve immuno…

A type of immune therapy called chimeric antigen receptor (CAR)-T cell therapy has revolutionized the treatment of multiple types of blood cancers but has shown limited e...

Digital twin opens way to effective treatment of i…

Inflammatory diseases like rheumatoid arthritis have complex disease mechanisms that can differ from patient to patient with the same diagnosis. This means that currently...