PALO ALTO, Calif., Feb. 22 /PRNewswire-FirstCall/ -- Telik, Inc. announced the initiation of a multicenter Phase 1-2a clinical study to evaluate the tolerability and pharmcokinetics of TELINTRA(TM) Tablets in patients with myelodysplastic syndrome (MDS). If successfully developed, this oral formulation may support the evaluation of TELINTRA in additional hematologic disorders characterized by low levels of one or more of the three blood cell lineages.
The TELINTRA Tablets trial follows the recently completed positive Phase 2 trial of the parenteral formulation of TELINTRA in MDS. In that trial, high levels of Hematologic Improvement (HI) assessed by the standard International Working Group MDS response criteria, including bilineage and trilineage HI, were observed. Responses were observed across all MDS FAB types and in patients with low, intermediate and high risk MDS. Results were reported at the 48th annual meeting of the American Society of Hematology in December 2005.
TELINTRA is a novel small molecule product candidate that has been shown to have myelorestorative activity when administered orally or by infusion in preclinical testing. It was discovered using Telik’s proprietary TRAP(TM) small molecule drug discovery technology.
Myelodysplastic syndrome, the most common hematologic malignancy in the elderly, originates in the stem cells. MDS causes ineffective formation of blood elements manifested by anemia, neutropenia and thrombocytopenia. The disease may be chronic, characterized by frequent transfusions and iron overload, infections and bleeding, or it may be aggressive with expected survival less than one year. MDS may progress to acute leukemia. There are an estimated 10,000 to 15,000 new cases of MDS diagnosed annually in the U.S., according to the American Cancer Society.
Telik, Inc. of Palo Alto, CA is a biopharmaceutical company focused on discovering, developing and commercializing novel small molecule drugs to treat serious diseases. The company’s most advanced drug development candidate is TELCYTA(R) (TLK286), a cancer cell-activated product candidate that is in three Phase 3 registration trials in advanced ovarian 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. Additional information is available at www.telik.com.
This press release contains “forward-looking” statements. These include statements concerning the potential for TELINTRA to treat myelodysplastic syndrome and other indications, the continuing development of the drug’s oral formulation, and Telik’s anticipated clinical studies of TELINTRA. There are important factors that could cause Telik’s results to differ materially from those indicated by these forward-looking statements, including, among others, that TELINTRA has not been determined to be safe or effective in humans or received regulatory approval for marketing, interim clinical results observed with the parenteral formulation of TELINTRA may not be predictive of clinical results with the drug’s oral formulation, and clinical trials of Telik’s product candidates, including TELINTRA, may take several years to complete and may not be successful. 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 ended September 30, 2005. TELIK, TRAP, TELCYTA and TELINTRA are trademarks of Telik, Inc. Telik does not undertake any obligation to update forward-looking statements contained in this press release.
Telik, Inc.
CONTACT: Carol D. DeGuzman, Senior Director, Corporate Communications ofTelik, Inc., +1-650-845-7728, or cdeguzman@telik.com
Web site: http://www.telik.com/
