PALO ALTO, Calif., June 7, 2011 /PRNewswire/ -- 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.
Background on MDS and TelintraThe 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, 10,000–20,000 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. There remains a critical need for effective, well tolerated therapies for MDS. 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. Telintra has been shown to stimulate multilineage differentiation of normal blood stem cell precursors; and induce cancer cell death, or apoptosis, in human leukemia cell lines. Telintra is also being evaluated in a Phase 1 clinical study in combination with lenalidomide (Revlimid®) in patients with MDS; and in an exploratory Phase 2 randomized study in patients with Severe Chronic Idiopathic Neutropenia. 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 or offers an alternative to RBC blood transfusions, the use of Telintra in Revlimid refractory or resistant patients, the use of Telintra in the treatment of SCIN, and the use of Telcyta for the treatment of cancer. 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 annual report on Form 10-K for the year ending December 31, 2010. 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.
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