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
"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
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 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
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
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