CuraGen, TopoTarget start phase 2 trial of PXD101 for acute myelogenous leukemia

New York, June 6 - CuraGen Corp. and TopoTarget A/S said dosing of patients has begun in a phase 2 clinical trial to evaluate the activity of PXD101 for the treatment of acute myelogenous leukemia.

The trial is being sponsored by the National Cancer Institute under a Clinical Trials Agreement with CuraGen and will be conducted at multiple sites in the United States.

PXD101 is a small molecule histone deacetylase inhibitor.

The trial is an open-label study being led by Kenneth A. Foon, director of clinical investigations at the University of Pittsburgh Cancer Institute, in collaboration with Mark Kirschbaum, director of new drug development at City of Hope in Duarte, Calif.

Patients under the age of 60 with relapsed or refractory AML, or patients over 60 with newly diagnosed or with relapsed or refractory acute myelogenous leukemia are eligible for enrollment.

Up to 55 patients will be enrolled and receive three week cycles of PXD101 administered by intravenous infusion.

Patients demonstrating complete or partial response, as defined by the Revised Recommendations of the International Working Group, will continue to receive treatment with PXD101 until disease progression.

The primary endpoint for the study is response rate, with secondary endpoints measuring overall survival and time to treatment failure.

"In preclinical experiments, PXD101 shows potent growth inhibitory activity on leukemic cell lines. The research we have conducted on HDAC [histone deacetylase] inhibitors at City of Hope suggests that agents like PXD101 affect many of the critical pathways cancer cells use for survival," said Kirschbaum in a news release. "Based on these intriguing results we have initiated patient treatment with PXD101 and look forward to evaluating the role of this HDAC inhibitor for the treatment of AML."

CuraGen is a Branford, Conn., biopharmaceutical company developing a pipeline of novel protein, antibody and small molecule therapeutics in the areas of oncology, inflammatory diseases and diabetes.

TopoTarget is a Copenhagen, Denmark, biopharmaceutical company dedicated to developing improved cancer therapies.

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