Epistem plc (LSE: EHP), the UK biotechnology company and Rottapharm|Madaus, the multinational pharmaceutical company today announced that favourable results have been obtained with the prophylactic use of CR 3294 in a series of preclinical models for intestinal mucositis.

CR 3294 is an inhibitor of pro-inflammatory gene expression involved in the pathogenesis of acute and chronic inflammatory events, endowed with potent Reactive Oxygen Species (ROS)-generation preventing effects, and with immunosuppressive and wound-healing properties. ROS are produced during cellular metabolism, but have the capacity to damage cells.

Rottapharm is developing CR 3294 for chemotherapy induced diarrhoea, mucositis, and inflammatory bowel disease. At present there are no approved oncology supportive care drugs to reduce the severity of intestinal mucositis, which is typically associated with cancer therapy and is caused by inflammation of the lining of the gastrointestinal tract, resulting in ulceration, severe diarrhoea, malnutrition and increased risk of infection. Several commonly administered anti-cancer drugs can damage the digestive tract in this way, including 5-fluorouracil (5-FU), methotrexate, cytarabine, capecitabine, and irinotecan.

Using Epistem’s proprietary stem cell models, CR 3294 has been shown to protect the small intestinal crypts from cytotoxic insult and reduce diarrhoea severity, particularly against frequently used chemotherapy agents such as 5-FU. 

Dr Catherine Booth, Managing Director of Epistem’s Contract Research Division commented “Epistem is a world leader in the supply of epithelial research models that measure the efficacy of oncology supportive care agents. CR 3294 protected normal tissue, to reduce the level of mucositis without increasing the risk of tumour growth. Such an increased therapeutic index may allow either improved quality of life for patients or opportunities for chemotherapy dose escalation, and therefore possible increased cure rates”.

Rottapharm announces CR 3294 is under active development and phase I studies are planned for 1st Q 2009.

Further information can be found at www.epistem.co.uk or by contacting:

Matthew Walls                                                   +44 (0)161 606 7258

Chief Executive Officer                                        +44 (0)7887 501998

Epistem Plc.

Mike Wort / Anna Dunphy                                   +44 (0) 207 861 3838

Financial PR/IR

De Facto Communications

Rottapharm I Madaus Contact

Lucio Rovati                                                       +39 (0)39 7390 318

Chief Executive Officer                                        +39 (0)39 7390 371

Giovanna Forlanelli                                             +39 (0)39 7390 416

Head of Communication Department                    +39 (0)39 7390 216