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Palo Alto, CA, - July 6, 2005 – Telik, Inc. (Nasdaq: TELK) reported positive interim data from two ongoing, multicenter Phase 2 clinical studies evaluating TELCYTA™ (TLK286) in combination with standard chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC). The data were presented at the Eleventh World Conference on Lung Cancer in Barcelona.
One trial is evaluating the triplet combination of TELCYTA with standard doses of carboplatin and paclitaxel in patients with Stage IIIB or IV NSCLC. At interim analysis, 35 patients had been enrolled and were evaluable for safety, and 26 of these patients were also evaluable for efficacy. Objective tumor responses were observed in 15 patients (58% objective response rate), including one complete response and 14 partial responses and the disease stabilization rate was 92%. The regimen was generally well tolerated.
Objective responses were evaluated by RECIST and confirmed by independent radiologic review. Responses were observed at all doses of TELCYTA and at all participating sites. Planned Phase 2 enrollment in this multicenter trial has been increased to confirm these interim results for future clinical studies.
A second Phase 2 trial is evaluating TELCYTA in combination with the standard dose of cisplatin in patients with Stage IIIB or IV NSCLC. Interim data from this trial were originally reported at the annual meeting of the American Society of Clinical Oncology in May 2005 and were updated at the Conference. Forty-nine patients were enrolled in the trial and were evaluable for safety, and 25 of these patients were also evaluable for efficacy at the Phase 2 dose level. Objective partial responses were observed in eight patients (32% objective response rate) and the disease stabilization rate was 88%. The regimen was generally well tolerated. Objective responses were evaluated by RECIST, confirmed by independent radiologic review, and observed at all participating sites. Enrollment in this trial is complete.
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.
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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