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news.Biopharmaceutical company Protherics and its co-development partner, Advancell have announced that the first patient has now been enrolled in a recently initiated Phase I/II clinical study of Acadra in B-cell chronic lymphocytic leukaemia.
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The phase I/II study will be conducted at sites in Belgium, France and Spain and will enroll up to 30 B-cell chronic lymphocytic leukaemia (B-CLL) patients who have relapsed or are refractory to existing chemotherapy. The open-label study is designed to assess the safety, tolerability, pharmacokinetics and the effects on Acadra on B-cell and T- cell counts.
Part I of the study will investigate escalating single doses of Acadra following in part II by an assessment of repeated doses. Results from part I of the study are expected in the H2 of 2008 and the final study results are expected in the H1 of 2009.