PALO ALTO, Calif., Dec. 11 /PRNewswire-FirstCall/ -- Telik, Inc. reported positive clinical results from a multicenter Phase 2 trial of TELINTRA(TM) in patients with myelodysplastic syndrome (MDS). The data were reported at the 47th Annual Meeting of the American Society of Hematology in Atlanta, GA.
Forty-three MDS patients were evaluable for efficacy. Of the 34 patients with multilineage blood cell dysfunction, 22 (65%) had clinically significant Hematologic Improvement (HI), as defined by the MDS International Working Group (IWG) hematologic response criteria. By individual cell line, HI was observed in 76% of the 25 patients with platelet abnormalities, an important finding given the limited treatment options for decreased platelet levels or thrombocytopenia. HI was observed in 64% of the 39 patients with red cell or erythroid abnormalities, and in 83% of the 29 patients with white cell or neutrophil abnormalities.
Responses were observed in all MDS FAB subtypes, in patients with low, intermediate or high risk disease by the MDS International Prognostic Scoring System (IPSS) and in patients with del (5q) and other chromosome abnormalities. Responses were accompanied by clinical symptom improvement, reduction or elimination of transfusion and/or growth factor support, and improvement in bone marrow maturation.
TELINTRA treatment was well tolerated in this predominantly elderly patient population. Most patients had failed one or more prior treatments including: 5-azacitidine, lenalidomide, thalidomide, other chemotherapeutic drugs, immune modulators, steroids, bone marrow transplantation, or investigational agents. The majority of patients also received prior blood product and/or growth factor support.
TELINTRA is a novel small molecule that has been shown in preclinical testing to have myelorestorative activity when administered orally or by infusion. It was discovered using Telik’s proprietary TRAP(TM) small molecule drug discovery technology.
Myelodysplastic syndrome is the most common hematologic malignancy in the elderly and 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 http://www.telik.com.
This press release contains “forward-looking” statements, including statements concerning the potential for TELINTRA to treat myelodysplastic syndrome. 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, 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.
Contact: Carol D. DeGuzman Senior Director, Corporate Communications Tel: 650 845 7728 Email: cdeguzman@telik.com
Telik, Inc.
CONTACT: Carol D. DeGuzman, Senior Director, Corporate Communications,+1-650-845-7728, cdeguzman@telik.com, of Telik, Inc.
Web site: http://www.telik.com/
