Telik Announces Top-Line Results of TELCYTA ASSIST-2 Trial
PALO ALTO, Calif., June 03, 2007 /PRNewswire-FirstCall/ -- Telik, Inc. announced top-line results from the ASSIST-2 Phase 3 study of TELCYTA (canfosfamide HCl, TLK286) versus gefitinib in the third-line treatment of non-small cell lung cancer (NSCLC).
The Phase 3, international, randomized, active control study enrolled 530 patients with advanced NSCLC whose disease had progressed following first-line platinum-based therapy and a second-line treatment. Two hundred sixty-five patients were randomized to TELCYTA treatment and 265 patients were randomized to gefitinib. The two arms of the study were balanced for key NSCLC disease characteristics and other prognostic or predictive factors.
The trial did not meet the primary endpoint of demonstrating superiority in overall survival or the secondary endpoint of demonstrating superiority in progression-free survival for the TELCYTA arm as compared with gefitinib. Median survival for the TELCYTA arm was 4.6 months as compared with 6.1 months for the active control arm. Median progression-free survival was 2.2 months for the TELCYTA arm as compared with 2.3 months for the gefitinib arm.
TELCYTA was very well-tolerated with infrequent hematologic or non- hematologic adverse events in a heavily pretreated population.
"We thank the patients, investigators and staffs who participated in this large clinical trial," said Gail L. Brown, M.D., Senior Vice President and Chief Medical Officer. "We plan to submit the results for presentation at a medical meeting later this year."
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, a tumor-activated small molecule product candidate in clinical development for the treatment of advanced ovarian cancer and non-small cell lung cancer. A second drug development candidate, TELINTRA(TM) (TLK199), is in clinical development for myelodysplastic syndrome. Telik's product candidates were discovered using its proprietary drug discovery technology, TRAP(TM), which enables the rapid and efficient discovery of small molecule drug candidates.
This press release contains "forward-looking" statements, including statements regarding the potential for TELCYTA to treat one or more types of cancer. 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 none of Telik's product candidates have been determined to be safe or effective in humans or been approved for marketing, clinical trials of Telik's product candidates may take several years to complete and may not be successful, 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. 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-Q for the quarter ended March 31, 2007. Telik does not undertake any obligation to update forward-looking statements contained in this press release.
TELIK, the Telik logo, TELCYTA, TELINTRA and TRAP are trademarks or registered trademarks of Telik, Inc.
Posted: June 2007