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Telik, Inc. (TELK) Announces the Publication of Two Reports in the Journal of Hematology & Oncology Describing the Results of a Clinical Study of Telintra® in Combination With Revlimid® and a Genomic Study Designed to Identify Genes That Predict Response to Telintra in Patients With Myelodysplastic Syndrome


5/15/2012 10:45:39 AM

PALO ALTO, Calif., May 15, 2012 /PRNewswire/ -- Telik, Inc. (Nasdaq: TELK) today announced two publications in the Journal of Hematology & Oncology. The first is "Phase 1 dose-ranging study of ezatiostat hydrochloride in combination with lenalidomide in patients with non-deletion (5q) low to intermediate-1 risk myelodysplastic syndrome (MDS)," Raza, A., et al., Journal of Hematology & Oncology 2012, 5:18 doi:10.1186/1756-8722-5-18; 30 April 2012. The publication may be found at http://www.jhoonline.org/content/pdf/1756-8722-5-18.pdf.

Telintra (ezatiostat) is a novel inhibitor of the enzyme glutathione S-transferase P1-1 (GSTP1-1), leading to activation of Jun kinase, a key regulator of cellular growth and differentiation of blood precursor cells. Telintra has been shown to cause clinically significant and sustained reduction in red blood cell transfusions, transfusion independence, and multilineage responses in MDS patients.

The rationale for this study was based upon the novel mechanism of action of Telintra, non-overlapping toxicity with Revlimid (lenalidomide), and the need for improved treatment options. Significant findings of the study included multilineage responses and good tolerability, supporting the further development of the combination in MDS as well as in other hematologic malignancies where Revlimid is a standard of care.

The second publication is entitled "Prediction of response to therapy with ezatiostat in lower risk myelodysplastic syndrome," Galili, N. et al., Journal of Hematology & Oncology 2012, 5:20 doi:10.1186/1756-8722-5-20; 6 May 2012. The publication may be found at http://www.jhoonline.org/content/pdf/1756-8722-5-20.pdf.

Telintra is in clinical development for the treatment of low to intermediate-1 risk MDS, where it has shown significant clinical activity, including durable red blood cell transfusion independence and multilineage responses. Since it would be of significant clinical benefit to be able to identify patients most likely to respond to Telintra before therapy is initiated, a gene marker analysis was performed using RNA available from 30 patients enrolled in a Phase 2 Telintra clinical trial. The Telintra response profile was found to contain two miRNAs that regulate expression of genes known to be implicated in MDS disease pathology. In addition, pathway analysis of the response profile revealed that the genes comprising the jun-N-terminal kinase/c-JUN molecular pathway, which is known to be activated by Telintra, were under-expressed in responders and over-expressed in non-responders, providing additional support for the novel mechanism of action of Telintra and a potential basis for a companion diagnostic.

Dr. Azra Raza, Professor of Medicine and Director of the MDS Center at Columbia University Medical Center and lead investigator, stated: "The gene expression profile shows that patients who under-express genes in the Jun kinase pathway are the ones likely to respond to Telintra. The pathway analysis of the response profile suggests that both the biology of the disease and the mechanism of action of Telintra are positively correlated. These exciting clinical and biologic observations provide further validation and insight into the novel mechanism of action of Telintra and its potential benefit to MDS patients."

Background on MDS and Telintra

The myelodysplastic syndrome is a heterogeneous group of clonal hematopoietic stem cell disorders characterized by ineffective hematopoiesis (blood cell production) involving one or more cell lineages (red blood cells, white blood cells, or platelets) and a variable risk of transformation to acute myeloid leukemia. It is estimated that MDS affects approximately 300,000 people worldwide. According to the American Cancer Society, 10,00020,000 new cases of MDS are diagnosed each year in the United States, with survival rates ranging from six months to six years. MDS patients often require multiple blood transfusions to manage their disease.

Telintra has a novel mechanism of action that inhibits an enzyme called glutathione S-transferase P1-1, which leads to activation of Jun kinase, a key regulator of cellular growth and differentiation of blood precursor cells; this mechanism induces cancer cell death, or apoptosis, in human leukemia cell lines. Telintra is also being evaluated in a Phase 2 clinical trial in Revlimid refractory and resistant deletion 5q MDS patients and a Phase 2b clinical trial in non-deletion 5q MDS patients. Additional information about Telintra is available at www.telik.com.

About Telik, Inc.

Telik, Inc. of Palo Alto, CA, is a clinical-stage drug development company focused on discovering and developing small-molecule drugs to treat cancer. The company's most advanced drug candidate is Telintra, a modified glutathione analog intended for the treatment of hematologic disorders including myelodysplastic syndrome, followed by Telcyta®, a cancer-activated prodrug for the treatment of a variety of cancers. 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 regarding the future development of Telintra, the safety and effectiveness of Telintra in treating MDS, whether Telintra treatment results in hematologic improvement in patients with MDS, whether Telintra reduces the need for, or offers an alternative to, red blood cell transfusions in patients with MDS, and whether genetic information can be used to predict patients' response to Telintra. These forward-looking statements are based upon Telik's current expectations, and there are important factors that could cause actual results to differ materially from those indicated by these forward-looking statements. 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 10-Q for the quarter ending March 31, 2012. 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.


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