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news.Telik has initiated Phase 1 clinical study to evaluate ezatiostat hydrochloride (Telintra, TLK199) tablets in combination with lenalidomide (Revlimid) in patients with myelodysplastic syndrome (MDS).
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The Phase 1 trial is an open label, multicenter, dose escalation study of Telintra in combination with lenalidomide in patients with non-deletion (5q-) low to intermediate-1 risk MDS. Telintra will be administered in escalating doses in combination with standard dose and schedule lenalidomide.
Reportedly, the study is designed to enroll up to 30 patients and the primary objectives are to assess the safety, tolerability and the maximum tolerated dose of Telintra in combination with lenalidomide. The rationale for the study included non-overlapping toxicities and different mechanisms of action of each component of the combination.
A Phase 2 Study is ongoing evaluating two different treatment regimens of Telintra in MDS patients, with results expected early this year. In addition, Telintra is also being evaluated in a Phase 2 randomized study for the treatment of patients with severe chronic idiopathic neutropenia (SCIN).