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Palo Alto, CA, October 6, 2005 — Telik, Inc. (Nasdaq: TELK) announced that the company has received permission to proceed, under an Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration, with the clinical study of an oral formulation of TELINTRA™. The initial clinical trial will be conducted in patients with myelodysplastic syndrome (MDS) and is in addition to the ongoing clinical trial using the parenteral formulation of TELINTRA. The oral formulation of TELINTRA, if successfully developed, may permit evaluation in additional clinical indications.
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™ small molecule drug discovery technology.
The myelodysplastic syndromes are a group of bone marrow disorders characterized by the abnormal formation, development and maturation of blood elements. In some cases, MDS progresses 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® (TLK286), a cancer cell-activated product candidate that is in three Phase 3 registration trials in advanced ovarian and non-small cell lung cancer. TELINTRA (parenteral formulation) is in Phase 2 development in MDS. 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 www.telik.com.
This press release contains “forward-looking” statements. These include statements concerning the potential for TELINTRA to treat myelodysplastic syndrome and other indications, the continuing development of the drug’s oral formulation, and Telik’s anticipated clinical studies of TELINTRA. 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, interim clinical results observed with the parenteral formulation of TELINTRA may not be predictive of clinical results with the drug’s oral formulation, 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 June 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.
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Contact:
Carol DeGuzman
Senior Director, Corporate Communications
Telik, Inc.
Tel 650-845-7728
Email cdeguzman@telik.com
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