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Threshold Pharmaceuticals to Stop Enrollment in Clinical Trial
Date:10/11/2007

REDWOOD CITY, Calif., Oct. 11 /PRNewswire-FirstCall/ -- Threshold Pharmaceuticals, Inc. (Nasdaq: THLD), today announced that, as part of a planned interim analysis, it would stop enrollment in a Phase 2 clinical trial evaluating the efficacy and safety of glufosfamide in patients with recurrent, sensitive small cell lung cancer.

The clinical trial utilized a two stage design to ensure there would be an adequate response rate to justify complete enrollment. Tumor response was evaluated at baseline and every six weeks using the Response Evaluation Criteria In Solid Tumors (RECIST). The first stage enrolled 21 patients as planned, but only one confirmed partial response was observed. If three or more responses were observed, an additional 29 patients would have been enrolled. Patients currently enrolled in the clinical trial will be given the option to continue in the trial.

"We are disappointed in the study results. While we recognize that response is not a perfect surrogate for survival, the low response rate indicates that glufosfamide is not sufficiently effective as a single agent for patients with small cell lung cancer. We had hoped to develop a better treatment option for patients with this disease, for whom the quality of life and treatment outcomes need improvement," said Barry Selick, Ph.D., chief executive officer of Threshold. "We want to thank the investigators, patients and their families for their participation in the study."

Phase 2 Clinical Trial Design

Approximately 50 patients with extensive recurrent sensitive small cell lung cancer, who had progressed at least 60 days after completing chemotherapy, were planned to enroll in the Phase 2, open-label, clinical trial at various s
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SOURCE Threshold Pharmaceuticals, Inc.
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