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Telik Announces Initiation of Phase 1 Clinical Study of Ezatiostat Hydrochloride (TELINTRA(R), TLK199) Tablets in Combination With Lenalidomide (Revlimid(R)) in Patients With Myelodysplastic Syndrome (MDS)
Date:1/25/2010

PALO ALTO, Calif., Jan. 25 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK) today announced the initiation of a Phase 1 clinical study to evaluate ezatiostat hydrochloride (TELINTRA, TLK199) tablets in combination with lenalidomide (Revlimid) in patients with Myelodysplastic Syndrome (MDS).

This 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.

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.

Telik previously reported positive Phase 1 results from a multicenter, dose escalation study of ezatiostat hydrochloride (TELINTRA, TLK199) tablets in patients with Myelodysplastic Syndrome (MDS) in a leading peer reviewed journal, Blood, 25 June 2009; Vol. 113, No.26, pp. 6533-6540.  Positive results from a separate Phase 1-2A study in MDS patients involving an intravenous formulation of TELINTRA were published in the Journal of Hematology and Oncology, 13 May 2009; Vol. 2, No.10, pp. 20-32.

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 patient
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