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www.fdanews.com/articles/67105-telik-completes-enrollment-in-assist-1-initiates-assist-3-and-reviews-status-of-assist-2-clinical-trials

TELIK COMPLETES ENROLLMENT IN ASSIST-1, INITIATES ASSIST-3 AND REVIEWS STATUS OF ASSIST-2 CLINICAL TRIALS

January 3, 2005

Telik has completed enrollment for the ASSIST-1 clinical trial of Telcyta (TLK286), and initiated a new randomized Phase III trial of Telcyta called ASSIST-3, in second-line platinum refractory or resistant ovarian cancer.

ASSIST-1 is a randomized Phase III study designed to enroll 440 women in the third-line treatment of platinum refractory or resistant ovarian cancer. Enrollment is complete.

ASSIST-3 is a randomized Phase III study designed to enroll 244 women with 122 to be treated with the combination of Telcyta plus carboplatin, and 122 to be treated with Doxil. The trial endpoints are objective response rate, progression-free survival and overall survival. The initial participating institutions are the Harvard Affiliated Hospitals including the Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital, and Beth Israel Deaconess Medical Center.

ASSIST-2 is a randomized Phase III study designed to enroll 520 patients in the third-line treatment of platinum resistant non-small cell lung cancer. Enrollment continues as planned, and the company anticipates completion of enrollment in the first quarter of 2005.