PALO ALTO, Calif., Dec. 8 /PRNewswire-FirstCall/ -- Telik, Inc. announced positive results from the multicenter Phase 1 dose-escalation study of TELINTRA(R) (ezatiostat HCl) Tablets in myelodysplastic syndrome (MDS) that support the initiation of Phase 2 clinical trials. The data were reported at the 49th annual meeting of the American Society of Hematology in Atlanta.
The objectives of the trial were to evaluate the safety and pharmacokinetics of TELINTRA Tablets (also known as TLK199 Tablets), and obtain preliminary indications of efficacy (International Working Group, IWG, 2000 criteria). The trial enrolled 45 patients and included all WHO classifications of MDS. Patients received one of ten dose levels of TELINTRA Tablets taken daily for seven days followed by two weeks of follow-up. Patients could receive planned therapy up to six months (eight cycles) until MDS progression or unacceptable toxicity.
TELINTRA Tablets were well-tolerated and no dose-limiting toxicities were observed. The most common non-hematologic toxicities were mild Grade 1 and 2 nausea, diarrhea and vomiting. Blood concentrations of the active metabolite of TELINTRA Tablets increased with dose levels.
Thirty-nine patients were evaluable for efficacy by objective Hematologic Improvement (HI) criteria. A dose-response curve was observed, with the majority of responses occurring in patients treated at the higher dose levels. Across all doses, neutrophil (HI-N) responses were observed in 21% (4 of 19) patients with neutrophil cytopenias. Seven of 21 patients (33%) with platelet cytopenias had HI-P. Among the 29 patients with erythroid cytopenias, HI-E was observed in six patients (21%). Some patients achieved red blood cell transfusion independence or a reduction in transfusion requirements, and one patient achieved platelet transfusion independence. One patient had a complete cytogenetic response.
"A tremendous need exists for new agents that are well-tolerated and efficacious for the treatment of MDS patients," said Azra Raza, M.D., Professor of Medicine and Director - MDS Program at St. Vincent's Comprehensive Cancer Center in New York City, and lead investigator on the TELINTRA Tablets study. "Having treated MDS patients with the intravenous formulation of TELINTRA, and now with the more convenient Tablet formulation, I am hopeful that planned Phase 2 dose-ranging trials will continue to demonstrate the potential for this agent to address early-stage MDS cytopenias as an alternative to blood support and best supportive care."
About TELINTRA
TELINTRA is an investigational small molecule designed to stimulate the production of blood cells in the bone marrow for the potential treatment of cytopenias associated with MDS or chemotherapy. Telik has developed both intravenous and Tablet formulations of TELINTRA, which was discovered through the application of Telik's proprietary TRAP(TM) drug discovery technology.
About Telik
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 candidates are TELCYTA(R), a tumor-activated small molecule product candidate in clinical development for the treatment of advanced ovarian cancer and non-small cell lung cancer; and TELINTRA(R), which is in development for the treatment of cytopenias due to myelodysplastic syndrome or chemotherapy. Telik's product candidates were discovered using its proprietary drug discovery technology, TRAP(TM), 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 regarding Telik's future development plans for TELINTRA. These forward-looking statements are based upon Telik's current expectations. There are important factors that could cause Telik's results to differ materially from those indicated by these forward-looking statements, including, among others, if clinical trials of TELINTRA are delayed or unsuccessful, Telik's business would suffer, if Telik's competitors develop and market products that are more effective than its product candidates or any product that Telik may develop, or obtain marketing approval before Telik does, Telik's commercial opportunity will be reduced or eliminated, and if Telik does not obtain regulatory approval to market products in the United States and foreign countries, Telik will not be permitted to commercialize its product candidates. 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, 2007. Telik does not undertake any obligation to update forward-looking statements contained in this press release.
TELIK, the Telik logo, TELCYTA, TELINTRA and TRAP are trademarks or registered trademarks of Telik, Inc.
