Navigation Links
Telik Announces Initiation of Two Phase 2 Randomized TELINTRA Studies
Date:5/20/2008

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.

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 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.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Telik Announces Presentation of Preclinical Data on Dual Inhibitors of Aurora Kinases and VEGFR2
2. Telik Announces Preclinical Data Demonstrating Anti-Cancer Activity of Dual Inhibitors of Aurora Kinase and VEGFR2
3. Telik Announces Telintra Presentation at American Society of Hematology Annual Meeting
4. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
5. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
6. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
7. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
8. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
9. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
10. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
11. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 , ... on Thursday, July 7, 2016 , , , , LOCATION: ... , , , , EXPERT PANELISTS:  , , , ... Senior Industry Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and ... The global pharmaceutical industry is witnessing an exceptional era. ...
(Date:6/23/2016)... 23, 2016  Guerbet announced today that it has ... Horizon Award . One of 12 suppliers ... for its support of Premier members through exceptional local ... and commitment to lower costs. ... of our outstanding customer service from Premier," says ...
(Date:6/23/2016)... 23, 2016 The Biotechnology industry ... to present great opportunities to investors. Stock-Callers.com assesses the ... Corp. (NYSE: XON ), Vertex Pharmaceuticals Inc. ... ARNA ), and Regeneron Pharmaceuticals Inc. (NASDAQ: ... and receive your complimentary trade alerts at: ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a Media Slicing ... their videos a whole new perspective by using the title layers in ProSlice ... , ProSlice Levels contains over 30 Different presets to choose from. FCPX ...
(Date:6/25/2016)... ... , ... Austin residents seeking Mohs surgery services, can now turn to Dr. ... Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to include ... in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson has ... he has implemented orthobiologic procedures as a method for treating his patients. The ... first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use ...
(Date:6/24/2016)... , ... June 24, 2016 , ... June 19, 2016 ... dangers associated with chronic pain and the benefits of holistic treatments, Serenity Recovery ... are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited ... To Recovery® program to drive cancer patients to and from their cancer treatments. ... highest quality of life and ongoing independence. Getting to and from medical treatments ...
Breaking Medicine News(10 mins):