Telik Announces Initiation of a Phase 2b Clinical Trial of Telintra® (Ezatiostat HCL) in Patients With Low to Intermediate-1 Risk Non-Deletion (5q) Myelodysplasti... ( PALO ALTO Calif. Oct. 13 2011 /- Teli...)

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Telik Announces Initiation of a Phase 2b Clinical Trial of Telintra® (Ezatiostat HCL) in Patients With Low to Intermediate-1 Risk Non-Deletion (5q) Myelodysplastic Syndrome

Date:10/13/2011

PALO ALTO, Calif., Oct. 13, 2011 /PRNewswire/ -- Telik, Inc. (Nasdaq: TELK) today announced the initiation of a Phase 2b clinical trial to evaluate Telintra treatment of patients with Low to Intermediate-1 IPSS Risk, transfusion dependent, non-deletion (5q) myelodysplastic syndrome (MDS), who have not been treated with hypomethylating agents (HMA) such as Vidaza® or Dacogen®. This patient population represents the majority of MDS patients and a significant unmet medical need.

This multicenter trial is intended to enroll up to 145 evaluable patients with 2 planned interim analyses, the first of which will be performed when data from 49 evaluable patients are available; and the second at 97 evaluable patients. The primary objective of the trial is to determine the hematologic improvement-erythroid response rate as determined by clinically significant transfusion reduction or independence, in accordance with International Working Group MDS criteria (2006). Secondary objectives include determination of response rates of increasing neutrophil and platelet levels, and safety. Pretreatment bone marrow samples from selected patients may be obtained to confirm genomic results obtained in previous studies.

In a similar, HMA-naive, transfusion-dependent population of 19 patients, 12 patients (63%) treated with Telintra achieved either clinically significant, according to International Working Group 2006 criteria, transfusion reductions (9 patients), or complete transfusion independence (3 patients), as previously reported in the journal Cancer (Raza, A., et al., doi: 10.1002/cncr.26469, September 1, 2011). Telintra was also shown to have multilineage responses resulting in improvement in MDS patients who additionally had low levels of neutrophils and/or platelets and, therefore, may offer an advantage in the treatment
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1. Telik Announces Publication in the Journal Cancer of a Phase 2 Randomized Multicenter Study of Two Extended Dosing Schedules of Oral Ezatiostat in Low to Intermediate-1 Risk Myelodysplastic Syndrome
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3. Telik Announces Presentation of New Data on the Characterization of Novel Ezatiostat (TELINTRA®, TLK199) Analogs at American Association for Cancer Research Annual Meeting
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