Telik Announces Initiation of a Phase 2 Clinical Trial of Telintra in Patients With Revlimid Refractory or Resistant Deletion 5q Myelodysplastic Syndrome

Telik, Inc. TELK today announced the initiation of a Phase 2 clinical trial to evaluate oral Telintra in patients with Revlimid refractory or resistant, deletion 5q myelodysplastic syndrome. This is a multicenter trial intended to enroll up to 117 evaluable patients. It employs a sequential design with two interim analyses. These patients are transfusion dependent with Low to Intermediate-1 Risk MDS. Telintra will be administered for 21 days followed by a one week rest period in four week cycles. The primary objective is to determine the hematologic improvement-erythroid response rate as measured by transfusion reduction or independence, in accordance with the International Working Group MDS 2006 criteria. Secondary objectives include determination of the hematologic improvement-neutrophil (HI-N) and hematologic improvement-platelet response rates, and safety.