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Threshold cancer drug fails to meet study goal

Threshold Pharmaceuticals has said that its pancreatic cancer drug glufosfamide has failed to meet the primary goal in a phase III trial.

Glufosfamide did not show a statistically significant improvement in overall survival compared to best supportive care in patients with pancreatic cancer who had relapsed after gemcitabine chemotherapy.

While the overall survival in patients in the glufosfamide arm was 18% higher compared to those who received best supportive care alone, the result was not statistically significant.

“While there was a trend toward efficacy with glufosfamide, unfortunately the trial did not meet its efficacy endpoint. Based upon the activity seen in this, and previous studies, we remain committed to our ongoing trials with glufosfamide.” said Barry Selick, Threshold's CEO.

As previously reported, Threshold has also completed enrollment in a phase II trial to evaluate patients with locally advanced and/or metastatic pancreatic adenocarcinoma previously untreated with chemotherapy.

Additionally, Threshold recently announced the start of two phase II trials to evaluate the activity and safety of glufosfamide in women with platinum-resistant ovarian cancer and in patients with recurrent, sensitive small-cell lung cancer. The company anticipates starting a trial in soft tissue sarcoma in the first half of 2007.