CuraGen, TopoTarget starts phase 1b/2 trial of PXD101 and Velcade to treat blood cancer

By Lisa Kerner

Erie, Pa., March 22 - CuraGen Corp. and TopoTarget A/S announced the start of patient dosing in a phase 1b/2 proof-of-concept trial to evaluate PXD101, a small molecule histone deacetylase (HDAC) inhibitor, in combination with Velcade (bortezomib) for the treatment of relapsed, refractory multiple myeloma (blood cancer). Preliminary results from this open-label, multi-center study are expected by mid-2007.

Both companies have signed agreements with the National Cancer Institute to study PXD101 in cancer, according to a company news release.

CuraGen said the goal of the phase 1b portion of the trial is to establish the maximum tolerated dose of PXD101 in combination with Velcade in up to 30 patients who have failed at least two prior lines of therapy for multiple myeloma.

Once the maximum tolerated dose is determined, CuraGen will begin the phase 2 portion of the study, enrolling up to 15 more patients with relapsed, refractory multiple myeloma who have failed at least one prior therapy.

The phase 2 study will evaluate the safety, pharmacokinetics, pharmacodynamics and antitumor activity of PXD101 in combination with Velcade.

"In laboratory studies, PXD101 has shown synergistic activity against multiple myeloma cells in vitro when combined with Velcade," principal investigator Dr. Seema Singhal said in the release.

"In addition, phase 1 results suggest that PXD101 is well tolerated and the safety profile does not appear to have any significant overlapping toxicities with Velcade. Based upon these results, we are very interested in evaluating the safety and activity of this intriguing combination for patients with multiple myeloma."

Published in-vitro studies indicate that that HDAC inhibitors and Velcade enhance killing of multiple myeloma cells when combined, officials said. CuraGen's internal research demonstrated that PXD101 has a synergistic effect with Velcade against multiple myeloma.

Multiple myeloma is the second most prevalent blood cancer in the United States, with nearly 50,000 individuals suffering from the disease, with more than 15,000 new cases expected to be diagnosed this year, the release stated.

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

TopoTarget is a fully integrated biopharmaceutical company based in Denmark.

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