CANCER.
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Immunotherapy in cancer: dSLIM - a combination of molecules that the immune response to promote after chemo - gives in phase I study with 17 metastatic colorectal cancer patients - an encouraging result.
dated August 3, 2003:The German company homologues recently published the favorable results of a randomized Phase II study at the University of Cologne to the effect of dendritic cells and other immune molecules called dSLIM in metastatic colorectal cancer in combination with chemotherapy. The dendritic cells were used immunostimulatoren, CEA-peptides, interleukin-2 and dSLIM in various combinations. Although the study does not contain many patients, the 100 patients approached, only 17 were about to participate in the study, the results were very encouraging, according to a press release of homologues.
Aim of the study was to measure how high the immune response would be after combination chemotherapy - 5FU, and foliniczuur Irinitocan - with metastatic cancer and the addition of the immunostimulatoren - molecules that the immune response should increase. Second objective was to see what the effect would be on the side and the interval between a recurrence.
Of the 17 patients, 9 were treated in the two relevant dSlimgroepen. Within these two groups of four patients showed a complete remission - cancer seemed completely disappeared. Four patients showed stable disease and one patient showed progression of cancer. In the three other groups, where no dSLIM was given as an addition was complete remission, 1 partial remission, one patient remained stable and 5 showed progression. Whether the positive effects mostly due to dSLIM is currently being investigated further, says a press release of homologues.
- PRESS RELEASE: dSLIM homologues Completed Phase II Study -
BERLIN (Dow Jones) - Germantown biotechnology company homologues Holding AG (G. MGN)
Thursday Announced the successful completion of a Phase II clinical study That
was aimed at Analysing the safety and efficacy of dSLIM, an immunomodulating
molecule developed by homologues.
dSLIM was Administered in combination with chemotherapy to patiënten with
meta-static colorectal cancer.
The study was Conducted at the Clinic I or internal medicine department of the
University of Cologne. The study was done by scientists from the University of
Cologne, Aventis Pharma, a unit of Aventis SA (AVE) and homologues in cooperation.
The study was whether a five-armed, randomized, single center design. In Addition to
Certain immuno logical markers, the selection criteria were included in the
requirement, patiënten That had to have raised levels of the CEA tumor marker.
Of a total of 100 patients screened, 17 Were Eligible for inclusion in the
study. Patients in all study arms Were Treated with a standard chemotherapy,
more consistent or a combination of 5-fluorouracil, folinic acid und Irinotecan.
The immunomodulator Were employed dendritic cells, CEA-peptide, interleukin-2
dSLIM and, in differential combinations.
The study design was aimed at Examining the immune response to the CEA peptide
after chemotherapy and immunomodulation in patient with CEA-positive,
meta-static colorectal cancer.
Secondary Objectives Were Clinical Characteristics Such As time to disease
progression and adverse effects associated with chemotherapy / immunotherapy
combination.
Were there no adverse effects observed with Other Than Those Usually
chemotherapy.
Out of a total of 17 patients, 9 Were Treated in the two homologues-relevant
dSLIM study arms. Within theses two arms, 4 patients showed total remission or
disease. In A Further 4 patients, within-the dSLIM groups, the disease was
Stabilised. In one patient the disease progressed constantly treatment.
Remaining in the three study arms in dSLIM Which was not included, there was
A complete remission, 1 partial remission, 1 Stabilization of disease and 5
cases or disease progression.
Whethere or not thesis results can-be attributed to the inclusion of dSLIM, willing
depend on the results of the immuno-logical data analysis, currently ongoing.
Looking to the future, this evaluation completed successfully or in a dSLIM
Phase II clinical study to compromise to enable homologues Conduct Further clinical studies
in kidney, and colorectal cancers, and Other, Using combinations of the companys
dSLIM proprietary technologies and midge vector DNA.
Beyond That, homologues willing capitalise on the potential of ITS dSLIM
immunomodulator Using it in combination with Other chemotherapeutics.
Potentially, could-not only the treatment outcomes of cancer patients be
improved, but many older, successful chemotherapeutics could-gain new patent
protection, if Developed in combination with dSLIM.




