CuraGen and TopoTarget Initiate Phase Ib/II Clinical Trial with PXD101 and Velcade(R) for Multiple Myeloma
BRANFORD, Conn., March 22 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN) and TopoTarget A/S (Copenhagen Stock Exchange: TOPO) announced today the initiation of patient dosing in a Phase Ib/II proof-of-concept trial to evaluate PXD101, a small molecule histone deacetylase (HDAC) inhibitor, in combination with Velcade(R) (bortezomib) for the treatment of relapsed, refractory multiple myeloma, a deadly form of blood cancer. Preliminary results from this open-label, multi-center study are expected by mid-2007.
The goal of the Phase Ib portion of this trial is to establish the maximum tolerated dose (MTD) of PXD101 in combination with Velcade(R) in up to 30 patients who have failed at least two prior lines of therapy for multiple myeloma. Following determination of the MTD, the study will enter Phase II and enroll up to 15 additional patients with relapsed, refractory multiple myeloma who have failed at least one prior therapy. The Phase II portion of the study will further evaluate the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of PXD101 in combination with Velcade(R). Patients will be enrolled at multiple sites in the United States.
"In laboratory studies, PXD101 has shown synergistic activity against multiple myeloma cells in vitro when combined with Velcade(R). In addition, Phase I results suggest that PXD101 is well tolerated and the safety profile does not appear to have any significant overlapping toxicities with Velcade(R)," stated Seema Singhal, M.D., Professor of Medicine at the Feinberg School of Medicine at Northwestern University in Chicago, and Principal Investigator. "Based upon these results, we are very interested in evaluating the safety and activity of this intriguing combination for patients with
multiple myeloma."
In vitro studies published in the literature have shown that HDAC inhibitors and Velcade(R) act through independent mechanisms that lead to enhanced killing of multiple myeloma cells when combined. In preclinical studies, PXD101 demonstrated growth-inhibitory activity against a variety of multiple myeloma cell lines at nanomolar concentrations. PXD101 also showed synergistic activity when combined with Velcade(R) against multiple myeloma during in vitro studies. These data support the evaluation of PXD101 in combination with Velcade(R) for the treatment of multiple myeloma.
"Preclinical studies suggest that HDAC inhibition plays a complementary role with Velcade(R), and our internal research demonstrates that PXD101 has a synergistic effect with Velcade(R) against multiple myeloma. This Phase Ib/II trial will evaluate the safety and potential activity of the combined regimen and we anticipate that preliminary results will be available by mid-2007," stated Timothy M. Shannon, M.D., Executive Vice President of Research and Development, and Chief Medical Officer at CuraGen. |
