Telik Reports Results of TELCYTA ASSIST-1 Trial
PALO ALTO, Calif., June 03, 2007 /PRNewswire-FirstCall/ -- Telik, Inc. reported results of the TELCYTA (canfosfamide HCl, TLK286) ASSIST-1 trial today at the 43rd annual meeting of the American Society of Clinical Oncology (ASCO).
The Phase 3, international, randomized, active control study enrolled 461 women with advanced, platinum refractory or resistant ovarian cancer whose disease had progressed following first-line platinum-based therapy and second- line treatment with either liposomal doxorubicin or topotecan. Two hundred thirty-two women were randomized to TELCYTA treatment and 229 women were randomized to treatment with one of the active control drugs (pegylated liposomal doxorubicin (PLD) or topotecan), depending upon their second-line treatment. The two arms of the study were balanced for key ovarian cancer disease characteristics, platinum refractory or resistant status, 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 on the TELCYTA arm as compared with the active control arm. Median survival on the TELCYTA arm was 8.5 months compared with 13.6 months on the active control arm (p <0.01). Median progression-free survival was 2.3 months on the TELCYTA arm compared with 4.3 months on the active control arm.
The performance of the drugs on the active control arm, PLD or topotecan, was unexpected based on reported data, and no known prognostic or predictive factors accounted for this result. In addition, patients treated with PLD tended to have superior overall survival as compared with patients treated with topotecan, also an unexpected result as published reports suggest that survival outcomes in platinum refractory or resistant ovarian cancer patients are similar for both agents.
TELCYTA was very well-tolerated with infrequent hematologic or non- hematologic adverse events in a heavily pretreated population.
"The known in vitro synergism with carboplatin, paclitaxel and anthracyclines and the excellent tolerability profile of canfosfamide in heavily pretreated, third-line ovarian cancer patients support further studies with canfosfamide in combination regimens in second line therapy," said Professor Dr. Ignace Vergote, Chairman, Department of Obstetrics and Gynecology, University Hospitals Leuven, Belgium, principal investigator for the ASSIST-1 trial. Dr. Vergote also is principal investigator for the ongoing ASSIST-5 Phase 3 trial which is evaluating the combination of TELCYTA plus PLD to PLD alone in second-line platinum refractory or resistant ovarian cancer.
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