CuraGen, TopoTarget begin phase 1/ 2 trial of PXD101 for liver cancer

By E. Janene Geiss

Philadelphia, July 14 - CuraGen Corp. and TopoTarget A/S announced Friday the start of patient dosing in a phase 1/ 2 clinical trial evaluating the safety and potential efficacy of PXD101, a small molecule histone deacetylase inhibitor for the treatment of inoperable liver cancer.

This trial is being sponsored by the National Cancer Institute under a clinical trials agreement with CuraGen for PXD101, according to a company news release.

The phase 1 portion of the study aims to establish the maximum tolerated dose, pharmacokinetics and safety profile of PXD101 for patients with inoperable hepatocellular cancer.

About 15 patients will be enrolled in the dose-escalation portion of the study and receive PXD101 in continuous three-week cycles until disease progression.

Following determination of the maximum tolerated dose, the phase 2 portion of the trial will be initiated and enroll up to 29 additional patients to assess the safety and potential efficacy of PXD101.

Assessment of tumor response will be evaluated using the Recist criteria. Secondary pharmacological studies evaluating histone acetylation, induction of cell-cycle arrest or apoptosis and changes in gene expression will be conducted in a subset of enrolled patients, 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 (5-FU), carboplatin, paclitaxel, cis-retinoic acid and Velcade (bortezomib) for injection.

PXD101 is being evaluated in multiple clinical trials as a potential treatment for multiple myeloma, T-cell lymphoma and colorectal and ovarian cancers, either alone or in combination with anticancer therapies.

In August 2004, CuraGen signed a clinical trials agreement with the National Cancer Institute under which the institute will sponsor several 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 announced the signing of a cooperative research and development agreement with the National Cancer Institute to conduct preclinical and non-clinical studies on PXD101 in order to better understand its antitumor activity and to provide supporting information for clinical trials.

CuraGen is a Branford, Conn., biopharmaceutical company.

TopoTarget is a Copenhagen, Denmark, biopharmaceutical company.

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