PALO ALTO, Calif., May 20 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK), today announced it has initiated two Phase 2 TELINTRA(R) studies -- one with TELINTRA tablets in myelodysplastic syndrome, or MDS, and a second with TELINTRA tablets in cancer patients at risk for chemotherapy-induced neutropenia, or CIN.
As previously reported, Telik completed a successful 65 patient Phase 2 study with the IV formulation of TELINTRA in MDS, and a dose-escalating Phase 1 study of the oral formulation of TELINTRA tablets in 45 patients. The data from the multicenter Phase 1 study was presented at the December 2007 meeting of the American Society of Hematology and the positive results support the initiation of these new Phase 2 clinical trials.
The randomized Phase 2 study with TELINTRA tablets in MDS is expected to enroll 86 patients, with an anticipated 20 sites participating in the study. Two dose schedules of TELINTRA tablets will be evaluated in low-to-intermediate one risk MDS patients. The primary objective of the study is to determine the hematologic improvement rate in erythroid or red blood cell precursors in each treatment group as assessed by the International Working Group criteria.
One group of patients will be given a starting dose of 4500mg of TELINTRA daily in divided doses for two weeks followed by one week off therapy. The second group of patients will receive the same dose of TELINTRA for three weeks followed by one week off therapy. Patients will receive treatment for up to six months, and if patients are continuing to receive clinical benefit after this initial period, the treatment may be extended for an additional six months with continuous daily dosing.
The second randomized Phase 2 study with TELINTRA tablets will be conducted in non-small cell lung cancer patients who are being treated with standard front line combination chemotherapy. This chemotherapy regimen is often complicated by the toxicity of the drugs in suppressing the white blood cell counts of these patients leaving them at higher risk for infection. The current standard of care is the use of injectable formulations of growth factors such as g-CSF (Neupogen(R), Neulasta(R)). A randomized Phase 2 study with TELINTRA tablets in CIN is expected to enroll 135 patients and is expected to be conducted at 24 sites. One group of 90 patients will receive chemotherapy followed the next day by a starting dose of 4500mg of TELINTRA per day in twice daily divided doses until white blood cell count recovery. Another group of 45 patients will be the chemotherapy-alone control group, which will receive standard supportive care following chemotherapy. The study's objective is to evaluate the effect of oral TELINTRA on accelerating hematologic recovery from chemotherapy.
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 investigational drug candidates in clinical development are TELINTRA, a modified glutathione analog for the treatment of cytopenias due to myelodysplastic syndrome or chemotherapy, and TELCYTA(R), a tumor-activated prodrug for the treatment of advanced ovarian cancer and non-small cell lung cancer. Telik's product candidates were discovered using its proprietary drug discovery technology, TRAP(R), which enables the rapid and efficient discovery of small molecule drug candidates.
This press release contains "forward-looking" statements, including statements regarding the future development of TELINTRA and TELCYTA. 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 or TELCYTA 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 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 U.S. and foreign countries, Telik will not be permitted to commercialize these 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 annual report on Form 10-K for the year ended December 31, 2007. 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.
|SOURCE Telik, Inc.|
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