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Santaris Pharma Presents Positive Clinical Data on SPC2996 in,Chronic Lymphocytic Leukaemia

e Cancer Center, University of Iowa, USA (Principal Investigator, USA)

SPC2996 was given by intravenous infusion on 6 repeated occasions over a two week period. Five different dosage levels were investigated. At the top dose of 4mg/kg/infusion, all 6 of the 6 patients studied showed a decrease in the severity of their leukaemia, with a rapid reduction in the numbers of circulating lymphocytes (white blood cells) being observed within 24 hours of the first administration of the drug. Five out of the 6 patients in this group showed a maximal reduction in lymphocyte count of 50% or more, indicating a clinically beneficial effect. See figure 1 attached.

A dose response to drug was also observed with patients treated with SPC2996 at 2 mg/kg/infusion having a transient reduction in lymphocytes of up to 30% and doses of 1 mg/kg/infusion having no effect.

Reductions in lymph node swelling was also observed in these patients, 2 out of 4 patients receiving drug at 4mg/kg/infusion and 1 out of 4 at 2 mg/kg/infusion showed a reduction in lymph node diameters of 50% or more. Overall, using standard clinical assessment procedures, 2 of the 6 patients treated with the top dose of drug showed a partial tumour response, one of 28-42 days and one of more than 182 days, and 3 patients had stable disease for periods of between 28 and 70 days. Mean time to disease progression was approximately twice as long (122 days) in the group receiving drug at 4mg/kg/infusion as in the groups receiving 2 or 1mg/kg/infusion (42 and 79 days).

Mechanism of Action

In cell culture and experimental models of disease, SPC2996 inhibits the production of the protein Bcl-2 and its beneficial effects in patients are thought to be due to the drug reducing Bcl-2 levels within cancerous CLL lymphocytes by binding specifically to and inactivating the messenger RNA for Bcl-2. High levels of Bcl-2 in CLL cells are associated with resistance to cancer cell death and poor disease ou
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