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Special Protocol Assessment Review for TLK286 (Telcyta) Completed

PALO ALTO, Calif., Oct. 1 /PRNewswire-FirstCall/ -- Telik, Inc. (NASDAQ:TELK) announced that the Phase 3 protocol for TELCYTA(TM) (TLK286) in non-small cell lung cancer (NSCLC) has successfully completed Special Protocol Assessment (SPA) review by the U.S. Food and Drug Administration.

The trial, designated ASSIST-2 (Assessment of Survival In Solid Tumors-2), will enroll approximately 500 patients with platinum refractory or resistant NSCLC who will be randomized to receive either TELCYTA(TM) or Iressa(R) (gefitinib) for the third-line treatment of NSCLC. The study is designed to evaluate whether TELCYTA(TM) treatment leads to an increase in survival as compared to the control treatment. The first Phase 3 TELCYTA(TM) protocol, for the ongoing ASSIST-1 trial of TELCYTA(TM) in women with platinum refractory or resistant ovarian cancer, previously underwent successful SPA review.

About Non-Small Cell Lung Cancer and TELCYTA(TM)
Lung cancer results in 28% of all cancer deaths in the U.S., and it is the leading cause of cancer deaths, according to the American Cancer Society (ACS). The ACS estimates that 171,900 new cases of lung cancer, most of the non-small cell type, will be diagnosed in 2003, and an estimated 157,200 deaths will result from the disease.

TELCYTA(TM) is a small molecule prodrug which is activated by GST P1-1, an enzyme present in higher levels in many human cancers than in normal tissues. Upon activation, an intracellular process known as apoptosis, or programmed cell death, is initiated.

Source: Telik, Inc.

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