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Telik Presents Results at ASCO From ASSIST-5 Trial of TELCYTA in Platinum Refractory and Resistant Ovarian Cancer
Date:5/31/2009

PALO ALTO, Calif., May 31 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK) today announced presentation at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida, of results from the ASSIST-5 Phase 3 randomized, multinational study of TELCYTA(R) (canfosfamide HCl) in combination with pegylated liposomal doxorubicin (PLD) vs. PLD alone in second-line therapy in platinum refractory or resistant ovarian cancer.

Study Design: Patients with platinum refractory or resistant ovarian cancer (platinum refractory, primary platinum resistant, secondary platinum resistant) by standard GOG criteria, with measurable disease were eligible for enrollment in the trial. A total of 125 patients at sites in the USA (44), Brazil (15), Belgium (8) and UK (6) were randomized with a 1:1 allocation to receive either TELCYTA in combination with PLD (administered IV at doses of 1000 mg/m2 and 50 mg/m2, respectively, every four weeks), or PLD alone (at 50 mg/m2 every four weeks). Patients were treated until tumor progression or unacceptable toxicity. Tumor assessments were conducted every 2 cycles or 8 weeks.

The trial design provided for the enrollment of 244 patients. The trial was interrupted by a clinical hold from June 2007 until October 2007. At the time of the clinical hold, 125 patients had been enrolled in the trial. As a result, 35 patients (21 on the combination treatment and 14 on PLD alone) were discontinued from their study treatment(s) and did not complete their assigned per protocol therapy. Although enrollment was permitted after the release of the clinical hold, Telik decided not to enroll additional patients, which impacted the powering of the study.

Patient Demographics: The treatment arms were well-balanced for patient demographics and
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SOURCE Telik, Inc.
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