Clavis' cytotoxic milestone.

Clavis Pharma, Oslo, (OSE: CLAVIS) has reached an important milestone in its haematology program with Elacyt, its novel cytotoxic agent. The phase I part of the ongoing clinical phase I/II study within haematological cancers has been successfully completed. The MTD (maximal tolerated dose) has been determined and clinical activity has been reported. Defining the MTD is a prerequisite for embarking on the phase II part of the study. The company is now in the process of confirming the dose and the optimal regimen to be used in the phase II part of the study where the efficacy of Elacyt will be evaluated. Phase II is estimated to start when the dose and regimen has been decided by the international clinical expert group by the end of April 2008.

Elacyt is a novel cytotoxic agent, an analogue of cytarabine, a backbone of therapy in acute leukaemia. It is in development for the treatment of haematological cancers as well as for solid tumours. In this ongoing phase I/II study 75 patients have been treated to date. Clavis Pharma reports that patients with haematological malignancies have tolerated the drug well at doses of up to 2500 mg/ m3/day both for 4 hour infusion and continuous infusion. The patient population in the phase II part are patients with late stage AML (acute myeloid leukaemia).