CuraGen and TopoTarget Initiate NCI-sponsored Phase I Clinical Trial of PXD101 and Azacitidine

10-Aug-2006

CuraGen Corporation and TopoTarget A/S announced the initiation of patient dosing in a Phase I clinical trial evaluating the safety and tolerability of PXD101, a small molecule histone deacetylase (HDAC) inhibitor, in combination with azacitidine for the treatment of advanced hematologic malignancies. This trial is being sponsored by the 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 being led by Dr. Olatoyosi Odenike, Assistant Professor of Medicine at the University of Chicago in Chicago, IL. The study 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 fifteen 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 eighteen 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.

PXD101 is a small molecule HDAC inhibitor being investigated for its role in the treatment of a wide range of solid and hematologic malignancies either as a single-agent, or in combination with other active anti-cancer agents, including 5-fluorouracil (5-FU), carboplatin, paclitaxel, cis-retinoic acid and Velcade(R) (bortezomib) for Injection. HDAC inhibitors represent a new mechanistic class of anti-cancer therapeutics that target HDAC enzymes and have been shown to: arrest growth of cancer cells (including drug resistant subtypes); induce apoptosis, or programmed cell death; promote differentiation; inhibit angiogenesis; and sensitize cancer cells to overcome drug resistance when used in combination with other anti-cancer agents.

https://www.bionity.com/en/news/56960/curagen-and-topotarget-initiate-nci-sponsored-phase-i-clinical-trial-of-pxd101-and-azacitidine.html