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:2/9/2016)... SAN DIEGO , Feb. 9, 2016 ... developing novel, clinical-stage therapies for sickle cell disease and heart ... common stock and warrants to purchase common stock in an ... other conditions, and there can be no assurance as to ... to the actual size or terms of the offering.   ...
(Date:2/9/2016)... LONDON , Feb. 9, 2016 Hearing ... amount of sound energy transmitted to the inner ear. ... and hearing bands. These devices are recommended for users ... eight hours. Earplugs refer to HPD that are inserted ... attenuation earplugs are designed to provide more natural sound ...
(Date:2/9/2016)... LONDON , Feb. 9, 2016 This ... surgical interventions, reported by the ICD-9 coding system in ... to the surgical procedure volumes, the report provides written ... and dynamics of the local markets. In addition, the latest ... --> --> The ...
Breaking Medicine Technology:
(Date:2/8/2016)... ... 08, 2016 , ... Brenton Engineering , powered by ... flow wrapped products at WestPack 2015, February 9-11, in Anaheim, California. This new ... semi-automatic or fully-automatic case packing with a small footprint, rugged, highly flexible, and ...
(Date:2/8/2016)... ... February 08, 2016 , ... Tingley Rubber ... Canada to provide its range of unique and advantaged protective solutions to ... that will provide bilingual customer service and marketing support. A new distribution center ...
(Date:2/8/2016)... ... February 08, 2016 , ... The Bell Agency, a ... latest beneficiary of their ongoing community enrichment program. The current campaign fundraises for ... Donations are now being accepted at: http://www.angelsanddoves.com/donate.html . , Angels & Doves ...
(Date:2/8/2016)... San Francisco, CA (PRWEB) , ... February 08, 2016 , ... ... helped raise $792,000 to help combat pancreatic cancer. , Gary D. Radine, who recently ... who also was the American Cancer Society’s 2015 CEO of the Year , ...
(Date:2/8/2016)... ... , ... Remember the old saying “rub some dirt on it”? Perhaps you ... “Calcium Bentonite Clay” the health benefits of integrating clay into a daily diet are ... A former motivational speaker, Perry A~ has since dedicated her life to learning about ...
Breaking Medicine News(10 mins):