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 patients with Severe Chronic Idiopathic Neutropenia (SCIN).
Background on MDS and TELINTRA
MDS is a heterogeneous group of blood stem cell disorders of increasing incidence. MDS is characterized by ineffective blood cell production involving one or more of the red cell, white cell or platelet lineages and with MDS patients having a variable risk of progression to leukemia. There remains a need for effective, well tolerated therapies for MDS having novel mechanisms of action. TELINTRA has a novel mechanism of action that inhibits a target enzyme called glutathione S-transferase P1-1 which in turn facilitates the activation of JNK kinase, a key regulator of cellular growth and differentiation of blood. TELINTRA has been shown to stimulate normal multilineage differentiation of blood stem cell precursors and induce cancer cell death in human leukemia cell lines. Additional information on TELINTRA is available at www.telik.com.
Telik, Inc. of Palo Alto, CA, is a clinical stage drug development company focused on discovering and developing small molecule drugs to treat cancer and inflammatory diseases. The company's most advanced investigational drug candidates in clinical development are TELINTRA, a modified glutathione analog for the treatment of cytopenias due to myelodysplastic syndrome or chemotherapy, and TELCYTA®, a tumor-activated prodrug for the treatment of advanced ovarian cancer and non-small cell lung cancer. Telik's product candidates were discovered using its proprietary drug discovery technology, TRAP®, which enables the rapid and efficient discovery of small molecule drug candidates.
This press release contains "forward-looking" statements, including statements regarding the future development of TELINTRA. These forward-looking statements are based upon Telik's current expectations. There are important factors that could cause Telik's results to differ materially from those indicated by these forward-looking statements, including, among others, if clinical trials of TELINTRA are delayed or unsuccessful, Telik's business would suffer, if Telik's competitors develop and market products that are more effective than its product candidates, or obtain marketing approval before Telik does, Telik's commercial opportunity will be reduced or eliminated, and if Telik does not obtain regulatory approval to market products in the U.S. and foreign countries, Telik will not be permitted to commercialize these product candidates. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Telik's periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled "Risk Factors" in its quarterly report on Form 10Q for the quarter ended September 30, 2009. Telik does not undertake any obligation to update forward-looking statements contained in this press release.
TELIK, the Telik logo, TELINTRA, TELCYTA and TRAP are trademarks or registered trademarks of Telik, Inc.
SOURCE Telik, Inc.