The primary endpoint for the trial is objective disease response which will be evaluated using standardized criteria. Secondary objectives for the study include evaluation of safety, time to response, duration of response, and survival following single-agent therapy with PXD101.
Preliminary results from this open-label, multi-center study are expected by mid-2007.
“Despite advances in the treatment of cancer, there has been no significant improvement in survival rates for patients with NHL. We look forward to exploring the role of PXD101 to address this unmet medical need and its potential benefit for patients with T-cell lymphomas,” stated Dr Timothy Shannon, executive vice president of R&D, and chief medical officer at CuraGen.
In August 2004, CuraGen signed an agreement with the National Cancer Institute (NCI) under which the NCI will sponsor several additional clinical trials to investigate PXD101 for the treatment of various cancers, both as a single-agent and in combination chemotherapy regimens.
In May 2005, TopoTarget signed a cooperative R&D agreement (CRADA) with the NCI to conduct preclinical and non-clinical studies on PXD101 in order to better understand its anti-tumor activity and to provide supporting information for clinical trials of the therapy.