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news.Genomics-based pharmaceutical company CuraGen Corporation and British/Danish biopharmaceutical firm TopoTarget A/S have begun dosing patients in a phase II clinical trial evaluating PXD101, a potential treatment for a deadly type of blood cancer.
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PXD101 is a small molecule histone deacetylase (HDAC) inhibitor being evaluated in advanced multiple myeloma.
The companies reported that initiation of this phase II trial triggered an undisclosed milestone payment to be made by CuraGen to TopoTarget. CuraGen also announced that the companies have successfully filed an investigational new drug application (IND) for PXD101 to the FDA, allowing initiation of this trial at clinical sites in the US.
The trial will evaluate the efficacy and safety of PXD101 administered as a single-agent and in combination with dexamethasone, for the treatment of advanced multiple myeloma in patients who have previously failed at least two treatment regimens. It is expected to enroll approximately 50 patients at multiple sites in Europe and the US and is expected to be complete by mid-2006.
“Based on results obtained in phase I, we are very pleased to advance PXD101 into phase II and evaluate it as a potential treatment for multiple myeloma,” stated Dr William Hahne, vice president of clinical development at CuraGen.
“Throughout 2005, we expect to initiate additional phase II trials that will investigate PXD101 as a potential treatment for other types of solid and hematologic cancers, and phase Ib/II studies to explore the safety and activity of PXD101 in combination with other chemotherapy regimens and newer targeted therapies.”