CuraGen, TopoTarget begin phase 1 trial for using oral PXD101 to treat solid tumors

By E. Janene Geiss

Philadelphia, Aug. 10 - CuraGen Corp. and TopoTarget A/S announced Thursday the start of a phase 1 clinical trial evaluating the administration of oral PXD101, a small molecule histone deacetylase inhibitor, in patients with advanced solid tumors.

The phase 1 study is an open-label, multi-center trial designed to establish the maximum tolerated dose for oral PXD101 administered once or twice daily, according to a company news release.

Patients will be treated with oral PXD101 in a dose-escalation regimen and may continue to receive up to eight or more treatment cycles depending on disease response.

Primary objectives for the study include evaluation of the safety, tolerability and pharmacokinetics of oral PXD101.

Secondary objectives include assessment of the pharmacokinetic profile of oral PXD101 administered once or twice daily at various dose levels and evaluation of antitumor activity.

The study is being conducted in the United States and Europe with preliminary results expected to be available by the end of 2007.

In a previously conducted pilot clinical study, oral PXD101 was demonstrated to achieve significant plasma concentrations and have an oral bioavailability of about 33%, officials said.

These data, in part, support the continued evaluation of PXD101 in this comprehensive phase 1 trial, the companies said.

CuraGen and TopoTarget said they continue to evaluate intravenous PXD101 in a number of phase 2 trials including PXD101 monotherapy in patients with multiple myeloma, T-cell lymphomas and acute myelogenous leukemia.

In addition, multiple phase 1b/2 clinical trials are being conducted to evaluate the combination of PXD101 with 5-fluorouracil for colorectal cancer, with carboplatin and paclitaxel for ovarian cancer, with cis-retinoic acid for advanced solid tumors, and with Velcade (bortezomib) for injection for multiple myeloma.

CuraGen is a Branford, Conn., biopharmaceutical company.

TopoTarget is a biopharmaceutical company based in Copenhagen, Denmark.

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