CuraGen and TopoTarget initiate phase I cancers trial

This trial is being sponsored by the US National Cancer Institute (NCI) under a clinical trials agreement with CuraGen for the development of PXD101.

The phase I trial is an open-label, dose-escalation study that aims to establish the maximum tolerated dose (MTD) and safety profile of PXD101 in combination with azacitidine for patients with advanced hematologic cancers, including relapsed or refractory acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS).

Up to 15 patients will be enrolled in the study and receive PXD101 and azacitidine in continuous four week cycles until disease progression. Following determination of the MTD, the study will enroll approximately 18 additional patients with MDS or AML who will receive treatment with either azacitidine monotherapy or PXD101 in combination with azacitidine. Pharmacodynamic endpoints will be evaluated to determine whether there is additive or synergistic activity of PXD101 in combination with azacitidine.

“Both PXD101 and azacitidine are believed to have different effects in restoring normal gene expression in cancer cells either through de-repression or upregulation. We are therefore quite interested in evaluating these agents in combination in order to determine whether additive or synergistic effects against certain hematologic cancers can be achieved,” commented Dr Olatoyosi Odenike, assistant professor of medicine at the University of Chicago.

PXD101 is also currently being evaluated in multiple clinical trials as a potential treatment for multiple myeloma, T-cell lymphoma, and colorectal and ovarian cancers, either alone or in combination with anti-cancer therapies.