Telik initiates Telintra Phase 2 trial in Revlimid refractory or resistant, del 5q MDS

Telik, Inc. (Nasdaq: 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 (del 5q MDS).

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 (HI-E) 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 (HI-P) response rates, and safety.  

This trial follows the recently completed Phase 2 study in non-del 5q MDS reported at the 52nd Annual Meeting of the American Society of Hematology 2010 in Orlando, FL, "Phase 2 Randomized Multicenter Study of Extended Dosing Schedules of Oral Ezatiostat HCl (Telintra), a Glutathione Analog, Glutathione-S-transferase P1-1 (GSTP1-1) Inhibitor, In Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)", Raza, A., Galili, N., Smith, S., et al. (Abstract #2910) where evidence of clinical activity was observed in this patient population.  Patients with del 5q MDS have limited treatment options after becoming resistant to Revlimid and represent an important unmet medical need.