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Clinical study shows biological and clinical activity in relapsed leukemia patients
Date:6/4/2008

LUGANO, SWITZERLAND, June 4, 2008 Finbarr Cotter, M.D., Ph.D., Professor of the Institute of Cell and Molecular Science at Barts and The London School of Medicine, today presented in an oral session "Clinical Caspase Activation in CLL by GCS-100: a Phase 2 Study" at the 10th International Conference on Malignant Lymphoma (10-ICML). The promising interim results from this ongoing clinical trial indicate that single-agent GCS-100 induces apoptosis (programmed cell death) in patients' CLL cells, reduces leukocyte count in some patients and is generally well tolerated. GCS-100 targets galectin-3, a protein over-expressed in cancer cells that promotes their survival, proliferation and metastasis.

The ongoing Phase 2 single-arm study of GCS-100 given intravenously as a single agent to relapsed CLL patients is designed to evaluate the effects of GCS-100 on various markers of apoptosis and to assess clinical activity and safety. Patients enrolled have had between one and two prior therapy regimens, which included chlorambucil, fludarabine, cyclophosphamide, and rituximab in combination or as a single agent. Of the nine patients enrolled to-date, six are evaluable for biological marker activity and five are evaluable for clinical activity.

The primary objective of the study is to evaluate the effect of GCS-100 on biomarkers of apoptosis in patients' CLL cells. Caspases -8 and -9 were activated in the CLL cells from all six evaluable patients, as measured by western blot analysis. DNA fragmentation in patients' CLL cells also was observed, strengthening the evidence that GCS-100 induces apoptosis.

The secondary objective of the study is to evaluate the effect of GCS-100 on peripheral blood leukocyte counts, which are aberrantly elevated in CLL patients. Of the five evaluable patients, two had significant reductions in leukocyte counts compared with baseline levels, including one with a 76% reduction and another with a 42% reduction and
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Contact: Michelle Linn
linnmich@comcast.net
508-362-3087
Linnden Communications
Source:Eurekalert

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