Ph I/II trial of Acadra enrolls first B-CLL patient

London, UK-based Protherics and USA-based Advancell say that the first patient has been enrolled in their recently-initiated Phase I/II clinical study of Acadra (acadesine) in B-cell chronic lymphocytic leukaemia.

The companies are jointly developing Acadra in this indication following a licensing and co-development agreement announced in December 2006. The study will be conducted at sites in Belgium, France and Spain and will enroll up to 30 B-CLL patients who have relapsed or are refractory to existing chemotherapy. The open-label trial is designed to assess the safety, tolerability, pharmacokinetics and the effects on Acadra on B-cell and T-cell counts. The first part of the study will investigate escalating single doses of Acadra followed, in part two, by an assessment of repeated doses. Findings from the first stage of the study are expected in the second half of the year and final results are anticipated in the first half of 2009.

According to the firms, most drugs currently used to treat B-CLL also kill T-cells, suppressing the patient's immune system and increasing the risk of serious infection, which is a common cause of death in patients with B-CLL. Acadra is a potentially selective treatment for B-CLL which has been shown to cause the death of B-cells whilst sparing T-cells in blood samples from patients with B-CLL. It has also shown the capacity to kill B-CLL cells that are resistant to current therapies, such as fludarabine.