CuraGen and TopoTarget Advance PXD101 Into Phase II Clinical Program

CuraGen and TopoTarget A/S have initated patient dosing in a Phase II clinical trial evaluating PXD101, a small molecule histone deacetylase (HDAC) inhibitor, as a potential treatment for advanced multiple myeloma, a deadly type of blood cancer.

The companies reported that initiation of this Phase II trial triggered an undisclosed milestone payment to be made by CuraGen to TopoTarget. CuraGen also announced it has successfully filed an investigational new drug application for PXD101 to the FDA, allowing initiation of this trial at clinical sites in the U.S.

This Phase II clinical trial is an open-label, multicenter study evaluating the efficacy and safety of PXD101 administered as a single-agent and in combination with dexamethasone, for the treatment of advanced multiple myeloma in patients who have previously failed at least two treatment regimens. The trial is expected to enroll approximately 50 patients at multiple sites in Europe and the U.S.

Following enrollment, patients will receive 900 mg/m2/day PXD101 administered intravenously once daily for five consecutive days every three weeks for two cycles. Patients will then be evaluated for tumor response by standard criteria and will either continue receiving up to eight cycles of PXD101 if they demonstrate response or stable disease, or begin combination therapy consisting of PXD101 and dexamethasone. The study is expected to be completed by mid-2006.