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Palo Alto, CA, May 17, 2005 — Telik, Inc. (Nasdaq: TELK) reported positive interim data from a multicenter Phase 1-2a clinical study evaluating TELCYTA™ (TLK286) in combination with cisplatin in the first-line treatment of advanced non-small cell lung cancer (NSCLC) at the annual meeting of the American Society of Clinical Oncology. In the trial, a 36% objective response rate (by RECIST) and an 86% disease stabilization rate were observed in the evaluable patients at the time of the interim analysis.
At the time of interim analysis, a total of 47 patients were enrolled in the trial. Of these, 22 patients treated at the Phase 2a dose (TELCYTA at 1,000 mg/m 2 and cisplatin 75 mg/m 2) were evaluable for efficacy. There were eight partial responses and eleven patients with stable disease. Objective responses were observed in subtypes including squamous cell, large cell, BAC and adenocarcinoma, as well as in males and females and current, former and never smokers. Overall the TELCYTA plus cisplatin combination was generally well tolerated, without unanticipated toxicities. Median survival has not yet been reached. Enrollment in the trial is now complete.
“TELCYTA appears to significantly augment the clinical activity of cisplatin without additive toxicity in these patients with advanced non-small cell lung cancer,” said Howard A. Burris III, M.D., Director of Drug Development for the Sarah Cannon Cancer Center, and Principal Investigator of the study. “These results warrant additional clinical trials using the combination of TELCYTA and platinum-based drugs.”
About TELCYTA
TELCYTA is a novel, small molecule tumor-activated drug candidate. It is activated by GST P1-1, an enzyme present in cancer cells. Upon activation, an intracellular process known as apoptosis, or programmed cell death, occurs. TELCYTA has been evaluated in multiple Phase 1 and 2 clinical trials as a single agent and in combination regimens in advanced ovarian, non-small cell lung, breast and colorectal cancer.
Three Phase 3 registration trials of TELCYTA are underway: ASSIST-1, a single agent trial in platinum refractory or resistant ovarian cancer; ASSIST-2, a single agent trial in platinum resistant non-small cell lung cancer; and ASSIST-3, a trial to evaluate TELCYTA in combination with carboplatin in second line platinum refractory or resistant ovarian cancer. TELCYTA was discovered through the application of Telik’s proprietary drug discovery technology, TRAP. For additional information on the ASSIST trials in ovarian cancer, visit www.ASSIST-ovarian.com; additional information on the ASSIST trial in non-small cell lung cancer may be found at www.ASSIST-2trial.com
About Telik
Telik, Inc. of Palo Alto, CA is a biopharmaceutical company working to discover, develop and commercialize small molecule drugs to treat serious diseases. The company’s most advanced drug development candidate is TELCYTA (TLK286), a tumor-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 adversely and 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 Telik several years to complete clinical trials of its 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 Telik’s competitors develop and market products that are more effective than Telik’s product candidates, or obtain regulatory approval before Telik does, Telik’s commercial opportunity will be reduced or eliminated; if Telik does not obtain regulatory approval to market its products in the United States and foreign countries, it will not be permitted to commercialize its product candidates; if Telik is unable to contract with third parties to manufacture its product candidates in sufficient quantities and at an acceptable cost, clinical development of product candidates could be delayed;and if Telik is unable to raise adequate funds in the future, it will not be able to continue to fund its operations and clinical trials to develop its 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 quarterly report on Form 10-Q for the quarter ended March 31, 2005. TELIK, TRAP, TELCYTA and TELINTRA are trademarks of Telik, Inc. All other brand names or trademarks appearing in this press release are the property of their respective owners. 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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