CuraGen, TopoTarget PXD101 well tolerated, shows some antitumor activity as single agent

By Angela McDaniels

Seattle, Nov. 18 - CuraGen Corp. and TopoTarget AS said interim data on 42 patients receiving PXD101 as a single-agent treatment for advanced solid tumors suggest the drug is well-tolerated following intravenous administration and may have potential antitumor activity.

Potential antitumor activity has been observed in two patients receiving the drug for more than one year: an epithelial T-cell thymoma patient exhibited 70% reduction of mediastinal disease and a patient with metastatic alveolar sarcoma has been stable for 13 months, the companies said.

Two additional patients, with a diagnosis of metastatic fibrosarcoma and breast cancer, have had stable disease for six months and four months, respectively.

Other data suggest that PXD101 has anticancer activity in vitro and in vivo against ovarian cancer cell lines as a single-agent and exhibits additive to synergistic activity when combined with other chemotherapeutic agents such as carboplatin and paclitaxel, the companies said.

The ongoing phase 1 open-label study was designed to determine the safety, maximum-tolerated dose, pharmacokinetics and pharmacodynamics of intravenously administered PXD101.

PXD101 was administered as a single-agent to patients with advanced solid tumors whose disease was resistant to standard therapy or for whom no standard therapy existed.

The most common adverse events were fatigue, nausea, vomiting and phlebitis, the companies said. No significant hematological toxicities were noted.

The data was presented Thursday during the European Organization for Research and Treatment of Cancer, National Cancer Institute and American Association for Cancer Research International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia.

PXD101 is also undergoing three proof-of-concept trials evaluating its potential treatment for multiple myeloma, colorectal and ovarian cancer and a phase 1b clinical trial in combination with carboplatin and/or paclitaxel for the treatment of advanced solid tumors, including ovarian cancer. Preliminary results from this study are expected to be available in the fourth quarter of 2006, the companies said.

PXD101 is a small molecule HDAC inhibitor. Such inhibitors represent a new mechanistic class of anticancer therapeutics that target HDAC enzymes and have been shown to arrest growth of cancer cells (including drug-resistant subtypes), induce programmed cell death, promote differentiation, inhibit blood vessel formation and sensitize cancer cells to overcome drug resistance, the companies said.

CuraGen, a Bradford, Conn.-based biopharmaceutical company, develops protein, antibody and small molecule therapeutics in the areas of oncology, inflammatory diseases and diabetes.

TopoTarget is a biopharmaceutical company based in Copenhagen, Denmark, that develops pharmaceutical compounds and identifies new indications for existing drugs for the treatment of cancer.

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