Fresenius Biotech

Catumaxomab, Representing a New Generation of Antibodies, Proved Efficient and Safe in Malignant Ascites
Data presented at 44th annual ASCO congress, Chicago, USA

München, Deutschland und Chicago, USA (ots) - Treatment with the trifunctional antibody catumaxomab significantly prolongs puncture-free survival in patients with malignant ascites, according to the results from a Phase II/III trial presented at the 44th American Society of Clinical Oncology (ASCO) congress. The prolonged time to next therapeutic puncture and reduced ascites signs and symptoms emphasize the clinical relevance of catumaxomab treatment. In addition, catumaxomab administered to patients of the control arm after study end showed a clear improvement in time to next puncture. Overall survival data indicate a survival benefit. Catumaxomab represents a new generation of antibodies in the field of oncology. A new drug application was submitted to EMEA in December 2007 for catumaxomab for the indication malignant ascites due to epithelial tumors (carcinomas). "The development of trifunctional antibodies represents a new targeted therapy for treatment of tumors, and these results provide clear evidence for efficacy and safety of catumaxomab in the management of malignant ascites, one of the conditions being investigated with a trifunctional antibody," said lead investigator Simon L. Parsons, Nottingham City Hospital, UK, at the presentation of the trial results in Chicago. The study involved 258 patients with malignant ascites due to epithelial tumors (carcinomas). Of those, 129 suffered from ovarian cancer while another 129 had non-ovarian cancers. Patients received either puncture (paracentesis) and four intraperitoneal infusions of catumaxomab within 11 days, or paracentesis alone (control group). The trial met its primary endpoint with high statistical significance. Patients treated with catumaxomab showed a median puncture-free survival (primary endpoint) of 46 days compared with 11 days in the control group (p< 0.0001). Puncture-free survival was defined as the period between the last infusion and the first subsequent necessary puncture or death, whichever occurred first. The median puncture-free time - a secondary endpoint which did not include the data from patients who died before the next ascites puncture was due - was 77 days versus 13 days (p< 0.0001). Patients receiving catumaxomab had an overall survival of 72 days compared with 68 days in the control group. Improved overall survival of catumaxomab treated patients with ovarian cancer (110 vs. 81 days; p=0.1543) and gastric cancer (71 vs. 44 days, p=0.0313) indicate survival benefit. The most common side effects observed during the trial, such as fever, nausea and vomiting were all due to catumaxomab's mode of action. These side effects were predictable, limited, manageable and mostly fully reversible. Malignant ascites can be caused by different epithelial tumors. Abdominal spread of tumor cells leads to an accumulation of fluid in the abdominal cavity and is associated with a poor prognosis. The most commonly used treatment of malignant ascites is puncture (paracentesis), which has to be carried out on average every eleven days and can lead to complications such as infection and fluid or protein deprivation. The trifunctional antibody catumaxomab is known to kill tumor cells in the peritoneal cavity and therefore attacks the primary cause of ascites formation. Trifunctional Antibody Catumaxomab The therapeutic objective of trifunctional antibodies is to generate a stronger immune reaction against tumor cells. Catumaxomab has two different antigen binding sites: While one arm of the antibody recognizes and binds to T cells, the other arm binds EpCAM (epithelial cell adhesion molecule) that is overexpressed in many types of epithelial cancers. Immune effector cells with Fc receptors (macrophages, monocytes, dendritic cells and natural killer cells) can also bind the Fc region of trifunctional antibodies. This simultaneous binding subsequently results in the costimulation and activation of T cells and accessory cells, enabling the generation of a strong immune response against tumor cells. Preclinical and clinical data also suggest a potential long-lasting effect to prevent cancer recurrence. Catumaxomab is further developed in various indications (e.g. gastric and ovarian cancer) in the early stages of disease addressing the underlying tumor. Trifunctional Antibodies Trifunctional antibodies are proteins that activate different cell types of the immune system simultaneously and redirect them specifically to tumor cells which are killed. Trifunctional antibodies are therefore very effective in destroying cancer cells and show a therapeutic effect even at very low dosages. Apart from catumaxomab two other trifunctional antibodies targeting other cancer antigens are currently undergoing clinical development. Trifunctional antibodies are being developed by TRION Pharma GmbH. Fresenius Biotech - a company of the Fresenius health care group - is focused on the development, marketing and commercialization of biopharmaceuticals in the fields of oncology and transplantation medicine. For further information please visit www.fresenius-biotech.com. Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2007, group sales were approx. EUR 11.4 billion. On March 31, 2008 the Fresenius Group had 116,203 employees worldwide. For further information please visit www.fresenius.de. Trion Pharma is a biopharmaceutical company that develops and produces trifunctional antibodies based on a globally patented technology platform together with Fresenius Biotech in Munich. For further information please visit www.trionpharma.de. This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release. ots Originaltext: Fresenius Biotech Im Internet recherchierbar: http://www.presseportal.ch Contact: Pressekontakt: Joachim Weith, Corporate Communications Tel.: +49 - 6172 - 6082101 Fax: +49 - 6172 - 6082294 e-mail: pr-fre@fresenius.de

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