THRESHOLD'S STUDY OF PANCREATIC CANCER DRUG MISSES ENDPOINT

Threshold Pharmaceuticals announced that a Phase III trial of glufosfamide did not show a statistically significant improvement in overall survival compared with best supportive care (BSC) in patients with metastatic pancreatic cancer who had relapsed after gemcitabine chemotherapy. While the overall survival in patients in the glufosfamide arm was 18 percent higher than in those who received best supportive care alone, the result was not statistically significant.

"Based upon the activity seen in this, and previous studies, we remain committed to our ongoing trials with glufosfamide," Barry Selick, Threshold's CEO, said. "Furthermore, we will continue to develop 2-deoxyglucose as well as our preclinical candidate HAP-302."

In this multinational, randomized, open-label, Phase III trial, 303 patients with metastatic pancreatic cancer who had relapsed after standard gemicitabine-containing systemic chemotherapy were randomized to receive glufosfamide every three weeks plus BSC or BSC alone. An independent data monitoring committee performed an interim analysis in May 2006 and recommended continuing the study through completion.

The primary efficacy comparison of overall survival was based on 261 deaths and did not reach statistical significance. The hazard ratio of glufosfamide to BSC was 0.85. The median survival of patients who were treated with glufosfamide was 105 days versus 84 days for the patients who received BSC.