National Editor

With a Phase III study already under way with Telcyta (TLK286) in ovarian cancer, Telik Inc. has gained the FDA's nod to go ahead with a second Phase III trial, this one in non-small-cell lung cancer.

Carol DeGuzman, senior director of corporate communications for Palo Alto, Calif.-based Telik, said the trial would start "before the end of the year." She declined to speculate how long the study would take.

The trial, called ASSIST-2 (Assessment of Survival In Solid Tumors-2), will enroll about 500 patients with platinum-refractory or resistant non-small-cell lung cancer (NSCLC), randomized to get either Telcyta or Iressa (gefitinib) for the third-line treatment of NSCLC.

Iressa is London-based AstraZeneca plc's NSCLC treatment approved earlier this year, and the study will test whether Telcyta (which is unpartnered) leads to increased survival. Iressa, which failed in Phase III against the condition in 2002, won marketing approval based on a 10 percent response rate in a Phase II study. (See BioWorld Today, Aug. 20, 2002, and May 6, 2003.)

"Responses in refractory NSCLC are relatively rare," DeGuzman said, noting that median survival for third-line NSCLC patients is "on the order of months."

Specifically, the proposed NSCLC trial with Telcyta has successfully completed the FDA's special protocol assessment review, which means the agency has agreed, among other things, on results required to show efficacy in a new drug application.

Telcyta is a small-molecule prodrug that is activated by GST P1-1, an enzyme present in higher levels in many human cancers than in normal tissues. Activation leads to apoptosis.

The study testing Telcyta in women with platinum-refractory or resistant ovarian cancer earlier underwent the same FDA review and is called ASSIST-1. (See BioWorld Today, March 28, 2003.)

The ovarian cancer trial is comparing Telcyta with Doxil (doxorubicin), from ALZA Corp., of Mountain View, Calif., and Hycamtin (topotecan hydrochloride) from London-based GlaxoSmithKline plc, both commonly used in the third-line ovarian cancer setting.

Interim data from three ongoing Phase II trials using Telcyta in combination with other agents for NSCLC and ovarian cancer will be disclosed in November, DeGuzman said.

Behind Telcyta in the pipeline is TLK199 for myelodysplastic syndrome. Data from a Phase I/II trial also will be disclosed in November at a scientific meeting, DeGuzman said.

Telik's stock (NASDAQ:TELK) closed Wednesday at $20.76, up 69 cents.