Acadra™ for B-CLL
Please click here for a PDF of the Acadra™ fact sheet.
Acadra™ (acadesine) , a novel nucleoside analogue, is an exciting potential new therapy for the treatment of chronic lymphocytic leukaemia (B-CLL), a haematological cancer where there is an excess of B-cells. Unlike existing chemotherapies for B-CLL, Acadra™ has been shown ex-vivo to selectively kill B-cells, whilst having only minimal toxicity to
T-cells. This selectivity for B-cells means that Acadra™ therefore has the potential to reduce the risk of serious infection and other side effects seen with current chemotherapies.
B-CLL is the most frequently occurring type of leukaemia in the western world and accounts for about 40 per cent of all leukaemias in those over 65 years of age; it is very rare in those below the age of 30 years. It follows an extremely variable course with overall survival times ranging from months to decades. B-CLL is considered incurable but temporary remission can be achieved with chemotherapies such as chlorambucil (Leukeran®, GSK), fludarabine (Fludara®, [Schering]) or cladrabine (Leustatin®, [Ortho Biotech]) and the monoclonal antibodies, alemtuzumab (MabCampath®, Schering) or rituximab (MabThera®, [Roche]), either given alone or in combination. Current therapies are toxic to both B-cells and T-cells. As a result, bone marrow function is impaired and this leads to an increased risk of infection, due to depletion of T-cells.
We have in-licensed the IP for the use of Acadra™ in the treatment of chronic lymphocytic leukaemia from Advancell, and we are codeveloping Acadra™ in this indication with them. Acadra™ was well-tolerated when previously studied for an unrelated indication and the pharmacokinetics of the drug have already been established in man. Protherics and Advancell have initiated a proof-of-concept phase 1/2 clinical study in Belgium, France and Spain that will enrol up to 30 B-CLL patients. The study will investigate B-cell selectivity in cancer patients and the preliminary results are expected mid 2008. We believe there may be an opportunity for acadesine to become the standard of care in B-CLL, alone or in combination with existing therapies.
We believe that Acadra™ is a relatively low risk development opportunity in an indication where there is a significant unmet need, and has the potential to be sold using our in-house sales force. We estimate that the potential market for Acadra™ in B-CLL could be worth up to $250 million per annum in the US and Europe. Acadra™ has been granted orphan drug status in the EU for B-CLL.