OSLO, Norway, 11 June 2007 - Clavis Pharma (OSE: CLAVIS) presented an update of data from its ongoing clinical Phase I/II study with ELACYT in hematologic cancers during a poster session at the Annual Meeting of the European Hematology Association (EHA) in Vienna. ELACYT is a novel cytotoxic agent in development for the treatment of hematologic cancers as well as for solid tumours. In this ongoing Phase I/II study Clavis Pharma reports that patients with hematologic malignancies have tolerated ELACYT well at doses up to 1150 mg/m²/day (2 hour infusion) and 675 mg/m²/day (continuous infusion). Initial results from this study were presented at AACR in April this year.
The phase I/II study is currently in its dose escalating phase with the aim to define the maximum tolerated dose, the optimal regimen and to characterize the safety profile of ELACYT given as a single agent in patients with hematologic malignancies. The second part of the study will evaluate the effect of ELACYT.
"The updated clinical results confirm the good safety profile seen with ELACYT so far" says Tom Pike, CEO of Clavis Pharma. "The progress of the study shows excellent recruitment in both continents high and we hope to be able to open the phase II part shortly."
The centres involved in this multicentre Phase I/II study are MD Anderson Cancer Centre, Houston, Texas, USA, Institute Paoli Calmettes, Marseille, France and Duke University Hospital, USA. A number of new sites have been recruited for the Phase II - efficacy part of the study. The Co-ordinating Investigator of the study is Professor Frank Giles, Chief, Division of Hematology and Medical Oncology, University of Texas Health Science Center at San Antonio