Gloucester reports positive interim results from Phase I/II myeloma study

In the study, patients with relapsed or refractory multiple myeloma who received romidepsin in combination with Velcade and dexamethasone had an overall response rate of 85% (17/20).

Approximately four (20%) patients achieved a complete response (CR), two (10%) a very good partial response, six (30%) a partial response (PR) and five (25%) a minor response (MR). And five of six patients previously exposed to Velcade responded in this study, including a negative immunofixation CR, one PR and three MRs. The median time to progression for all patients was seven months, the company said.

The Phase I/II study is an open-label, single-center, single-arm, dose-escalating trial of romidepsin in combination with Velcade and dexamethasone followed by maintenance romidepsin therapy until disease progression. In the Phase I portion of the study which enrolled 10 patients, the maximum tolerated dose was determined to be 10mg/m2 of romidepsin, 1.3mg/m2 of Velcade and 20mg of dexamethasone.

Alan Colowick, CEO of Gloucester Pharmaceuticals, said: The positive data Gloucester presented in cutaneous T-cell lymphoma (CTCL), peripheral T-cell lymphoma and now multiple myeloma strongly supports the potential broad utility of our novel histone deacetylase inhibitor, romidepsin, as both a single-agent and in combination therapy.

We continue to make significant strides in the development of romidepsin and expect to submit a new drug application for romidepsin for the treatment of CTCL by the end of 2008.