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 of MDS. Telintra has the potential for combining with other agents used to treat MDS. Telintra has been well-tolerated with mostly grade 1 or 2 gastrointestinal side effects.
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. 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; and induces cancer cell death, or apoptosis, in human leukemia cell lines. Telintra is also being evaluated in a Phase 2 clinical study in Revlimid® refractory and resistant 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 treatment results in transfusion reduction or independence or offers an alternative to blood transfusions, and the enrollment of patients in, and data relating to, the clinical trials described above. 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 period ending June 30, 2011. 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.