TopoTarget and CuraGen initiate Phase II Trial with PXD101 for T-Cell Lymphomas (TCLs)

TopoTarget A/S (CSE: TOPO) and CuraGen Corp. (Nasdaq: CRGN) have started treating patients in a new Phase II study of their histone deacetylase (HDAC) inhibitor, PXD101.

The study will evaluate the efficacy and safety of PXD101 as a novel anti-cancer agent in the treatment of cutaneous T-cell (CTCL), peripheral T-Cell (PTCL) and other T-cell lymphomas of the non-Hodgkin’s type (NHL). Preliminary results from this study are expected by mid-2007.

"PXD101 has demonstrated excellent preclinical activity against T-cell lymphoma cancer cell lines and HDAC inhibitors as a novel drug class have already shown clinical efficacy against CTCL,” stated Peter Buhl Jensen, M.D., CEO of TopoTarget. “Despite advances in cancer treatment, there has been no significant improvement in survival rates for patients with T-cell NHLs. We are excited to explore the ability of PXD101 to address this unmet medical need and its potential to benefit patients with this type of cancer.”

The Phase II trial is an open-label, multi-centre study, designed to establish the efficacy and safety of PXD101, a small molecule HDAC inhibitor, as a single-agent treatment for CTCL, PTCL, and other T-cell NHLs. Patients with T-cell NHLs will be enrolled into one of two parallel study arms depending on disease classification. Approximately 25 patients will be enrolled initially and an additional 70 patients will be enrolled following demonstration of activity. The primary endpoint for the trial is objective disease response using standardised criteria. Secondary objectives for the study include evaluation of safety, time to response, duration of response and survival following single-agent treatment with PXD101. The phase II trial will be conducted at clinical centres in the US.

The initiation of this Phase II trial in T-cell lymphomas is in accordance with TopoTarget‘s clinical development plans for PXD101.