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Telik Announces Top-Line Results From Assist-5 Trial of Telcyta(R) in Combination With Pegylated Liposomal Doxorubicin in Platinum Refractory and Resistant Ovarian Cancer
Date:10/29/2008

PALO ALTO, Calif., Oct. 29 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK) today announced top-line results from an interrupted Phase 3 randomized study of Telcyta (canfosfamide HCL) in combination with pegylated liposomal doxorubicin (PLD) versus PLD alone in second-line therapy in platinum refractory, primary platinum resistant or secondary platinum resistant ovarian cancer (definitions of platinum status are provided below).

On an intent-to-treat (ITT) basis for the 125 enrolled patients, the median progression-free survival (PFS) was 5.6 months on the Telcyta plus PLD arm compared to 3.7 months on the PLD control arm, p = 0.7243 and hazard ratio (HR) = 0.92. The study did not meet the statistical significance p less than or equal to 0.05. The overall response rate as measured by RECIST was 12%, including one complete response (CR) for the Telcyta plus PLD arm and 8% for the PLD control arm.

Of the 125 patients in the ITT population, a prespecified analysis was conducted for 75 patients with platinum refractory or primary platinum resistant disease, including 40 patients on the Telcyta plus PLD arm and 35 patients on the PLD control arm. The median PFS of these patients was 5.6 months for the Telcyta plus PLD arm compared to 2.9 months for the PLD control arm, p = 0.0425 and HR = 0.55. The response rate, as assessed by RECIST, was 15%, including one CR for the Telcyta plus PLD arm and 6% for the PLD control arm.

The initial trial design provided for the enrollment of 244 patients. The trial was interrupted by a brief clinical hold, followed by a partial clinical hold from June 2007 until October 2007. At the time of the clinical hold, 125 patients had been enrolled in the trial. Although enrollment was permitt
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