TopoTarget and CuraGen Initiate NCI-Sponsored Phase II Trial of PXD101 for Ovarian Cancer
TopoTarget A/S and CuraGen Corporation announced the initiation of patient dosing in a Phase II clinical trial evaluating the antitumor activity of intravenous PXD101, a small molecule histone deacetylase (HDAC) inhibitor, for the treatment of ovarian cancer. This trial is being sponsored by the National Cancer Institute (NCI) under a clinical trials Agreement with CuraGen for PXD101.
The Phase II trial is an open-label study being led by Dr. Amit Oza at Princess Margaret Hospital in Toronto, Canada. Patients with either advanced platinum resistant ovarian tumors or micropapillary/borderline low malignant potential (LMP) ovarian carcinoma may be enrolled for treatment with PXD101. Patients may have received no more than three prior lines of therapy. Upon enrollment, patients will receive intravenous PXD101 daily for five days in three week cycles until disease progression. The primary endpoint for the study is determination of objective disease response, as evaluated by the RECIST criteria. Secondary endpoints include evaluation of safety and tolerability of PXD101, stable disease rates, duration of response, progression-free survival, as well as median and overall survival. Up to 62 patients at sites across Canada and the United States will be enrolled into the study.
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, azacitidine and Velcade® (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.
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