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Palo Alto, CA, - December 17, 2004, – Telik, Inc. (Nasdaq: TELK) stated that enrollment continues as planned in the ASSIST-2 Phase 3 clinical study of TELCYTA™ in platinum resistant non-small cell lung cancer (NSCLC), and reiterated its guidance that enrollment in the trial is anticipated to be complete in the first quarter of 2005. The ASSIST-2 study, which is comparing TELCYTA to gefitinib (Iressa®) in the third-line treatment of NSCLC, was reviewed by the U.S. Food and Drug Administration under the Special Protocol Assessment procedure and, assuming the agreed-upon endpoints are met, could support a New Drug Application filing for TELCYTA in the third-line NSCLC setting.
About Telik, Inc.
Telik, Inc. of Palo Alto , CA is a biopharmaceutical company dedicated to discovering, developing and commercializing small molecule drugs to treat cancer and other serious diseases. The company’s most advanced drug development candidate is TELCYTA™ (TLK286), a cancer cell-activated small molecule product candidate that is in Phase 3 registration trials in advanced ovarian and non-small cell lung cancer. 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. For this purpose, any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including any statements regarding the potential for TELCYTA (TLK286) to treat one or more types of cancer. There are a number of important factors that could cause Telik's results to differ materially from those indicated by these forward-looking statements, including, among others, the following: none of Telik’s product candidates, including TELCYTA, has been determined to be safe or effective in humans or received regulatory approval for marketing; it may take us several years to complete clinical trials of our product candidates, including TELCYTA, prior to seeking regulatory approval for any indication; success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and interim results of clinical trials do not necessarily predict final results; if our competitors develop and market products that are more effective than our product candidates, or obtain regulatory approval before we do, our commercial opportunity will be reduced or eliminated; if we do not obtain regulatory approval to market products in the United States and foreign countries, we will not be permitted to commercialize our product candidates; if we are unable to contract with third parties to manufacture our product candidates in sufficient quantities and at an acceptable cost, clinical development of product candidates could be delayed;and if we are unable to raise adequate funds in the future, we will not be able to continue to fund our operations and clinical trials to develop our product candidates. These and other risks are detailed from time to time in our SEC filings, including under the heading “Additional Factors that May Effect Future Results” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2004 . Telik does not undertake any obligation to update forward-looking statements.
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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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