CuraGen, TopoTarget start PXD101 and azacitidine trial to treat blood cancers

By E. Janene Geiss

Philadelphia, Aug. 8 - CuraGen Corp. and TopoTarget A/S announced Tuesday the start of patient dosing in a phase 1 clinical trial evaluating the safety and tolerability of PXD101, a small molecule histone deacetylase inhibitor, in combination with azacitidine for the treatment of advanced hematologic malignancies.

This trial is being sponsored by the National Cancer Institute under a Clinical Trials Agreement with CuraGen for the development of PXD101, according to a company news release.

The phase 1 trial is an open-label, dose-escalation study that aims to establish the maximum tolerated dose and safety profile of PXD101 in combination with azacitidine for patients with advanced hematologic cancers, including relapsed or refractory acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia or myelodysplastic syndromes.

Up to 15 patients will be enrolled in the study and receive PXD101 and azacitidine in continuous four-week cycles until disease progression, officials said.

Following determination of the maximum tolerated dose, the study will enroll about 18 additional patients with myelodysplastic syndromes or acute myelogenous leukemia 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, officials said.

PXD101 is a promising 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 anticancer agents, including 5-fluorouracil, carboplatin, paclitaxel, cis-retinoic acid and Velcade (bortezomib) for injection.

CuraGen is a Branford, Conn., biopharmaceutical company.

TopoTarget is a biopharmaceutical company based in Copenhagen, Denmark.

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