PXD101 shows promise in Phase II MM trial

Danish drugmaker TopoTarget AS and USA-based Curagen say that preliminary results from a Phase II trial of their small-molecule histone deacetylase inhibitor PXD101 in the treatment of advanced multiple myeloma indicate that the drug is an effective therapy when used in combination with dexamethasone. The data, which were presented at the annual meeting of the American Society of Hematology in Orlando, Florida, also showed that PXD101 was well-tolerated when administered via intravenous injection.

The Phase II open-label, multicenter assessment was designed to examined the efficacy of the drug as both a monotherapy and in combination with dexamethasone in the treatment of patients with advanced MM who have experienced at least two failed prior treatment regimens. Of the 25 patients who enrolled, six achieved stable disease after receiving two cycles of the drug as a monotherapy. Subjects who experience progression following PXD101 treatment were entitled to receive the agent in combination with dexamethasone. An objective response was achieved by 50% of this group.

In a separate presentation, the firms revealed that PXD101, in combination with bortezomib, demonstrated enhanced anti-tumor activity when applied to cell lines derived from MM sufferers who had developed bortezomib-resistance. The companies added that, in total, they are currently assessing the agent in 15 trials, with the aim of initiating registrational studies during 2008.