Healthcare Industry News: ASSIST-1
News Release - May 2, 2006
Telik Announces Initiation of New TELCYTA Phase 3 Clinical Trial and Updates Status of Ongoing Phase 3 Ovarian Cancer Clinical TrialsPALO ALTO, Calif., May 2 (HSMN NewsFeed) -- Telik, Inc. (Nasdaq: TELK ) announced the initiation of ASSIST-5, an international Phase 3 clinical trial that will compare treatment with the combination of TELCYTAŽ and DoxilŽ to treatment with Doxil alone in women with platinum refractory or resistant ovarian cancer. Telik plans to enroll approximately 244 women with 122 randomized to each treatment arm. Trial endpoints include objective response rate, progression-free survival and overall survival. ASSIST-5 is based on the positive results previously reported from a multicenter Phase 2 study of the combination of TELCYTA plus Doxil in platinum refractory or resistant ovarian cancer.
"ASSIST-5 is an important step in the development program for TELCYTA since Doxil is a frequently prescribed second-line drug for ovarian cancer." said Michael Inouye, Senior Vice President, Commercial Operations. "If the trial is successful, it may offer additional treatment strategies for many patients initially treated with platinum-containing regimens."
Telik has two additional Phase 3 trials ongoing in platinum refractory or resistant ovarian cancer, ASSIST-1 and ASSIST-3. The ASSIST-1 trial is evaluating TELCYTA in third line platinum refractory or resistant ovarian cancer. Enrollment in this trial was completed in December 2004 and the pre- specified number of events has not occurred. Enrollment has recently been completed on the ASSIST-3 trial which is evaluating the combination of TELCYTA plus carboplatin versus Doxil in 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. TELCYTA is in four Phase 3 registration trials in advanced ovarian and non-small cell lung cancer. A second drug development candidate, TELINTRA(TM) (TLK199), is in Phase 2 clinical development in 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. Additional information is available at www.telik.com.
This press release contains "forward-looking" statements, including statements regarding the potential for TELCYTA or TELINTRA 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-K for the year ended December 31, 2005. Telik does not undertake any obligation to update forward-looking statements contained in this press release.
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