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Telik begins new phase 3 trial of Telcyta in ovarian cancer
By Lisa Kerner
Erie, Pa., May 2 - Telik, Inc. said it began its international phase 3 clinical trial (Assist-5) comparing treatment with the combination of Telcyta and Doxil to treatment with Doxil alone in women with platinum refractory or resistant ovarian cancer.
The company plans to enroll about 244 women with 122 randomized to each treatment arm.
Endpoints of the phase 3 trial include objective response rate, progression-free survival and overall survival.
Telik said Assist-5 is based on positive results from its 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," senior vice president Michael Inouye said in a company news release.
"If the trial is successful, it may offer additional treatment strategies for many patients initially treated with platinum-containing regimens."
Two other phase 3 trials, Assist-1 and Assist-3, in platinum refractory or resistant ovarian cancer are ongoing.
Telik is a Palo Alto, Calif., biopharmaceutical company specializing in novel small molecule drugs.
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