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news.Gentium's lead product, Defibrotide, is to be the subject of an independent phase I/II study in multiple myeloma to test whether the drug increases the effectiveness of standard treatments for the disease.
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Defibrotide will be tested in combination with Melphalan, Prednisone, and Thalidomide (MPT) at approximately 10 cancer centers in Italy.
The study is designed to assess the safety and the efficacy of Defibrotide with MPT regimen as a salvage treatment in advanced refractory multiple myeloma (MM) patients.
The phase I component of the study will combine oral MPT with escalating doses of Defibrotide to determine the maximum tolerated dosage of Defibrotide combined with MPT.
In the Phase II component of the study, the oral MPT regimen will be combined with the maximum tolerated dosage of Defibrotide and administered to 20 consecutive patients to assess response rate and clinical efficacy.
“Preclinical studies… were very promising and suggest that Defibrotide sensitizes MM cells to anti-MM agents in the bone marrow by preventing the molecular cascade of events triggered by MM-bone marrow stromal cells contactm,” said Dr Laura Ferro, chairman and CEO of the company. “This pre-clinical study provided the framework for this Phase I/II clinical trial of oral MPT in combination with Defibrotide in the treatment of multiple myeloma.”