At the Hambrecht & Quist annual conference last week, Alkermes said that it has completed its target enrollment of 49 patients into three Phase I/II trials of RMP-7, in combination with other drugs, in patients with brain tumors and cryptococcal meningitis. The company also said that it had completed a Phase I study of the product which gave quantitative data supporting the agent's effect of increasing brain tumor permeability to a drug compound.
Based on a preliminary analysis of the results of these trials, Alkermes plans to begin enrolling patients into its Phase II trials program for the compound in the first quarter of this year. These trials will be carried out both in the USA and Europe, and will initially investigate the efficacy of RMP-7-enhanced carboplatin in the treatment of patients with recurrent glioma. Company-sponsored studies for the cryptococcal meningitis indication are not being planned because of a significant decline in the incidence of the disease.
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