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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.
Contact:

Pressekontakt:

Joachim Weith,
Corporate Communications
Tel.: +49 - 6172 - 6082101
Fax: +49 - 6172 - 6082294
e-mail: pr-fre@fresenius.de