Threshold initiates phase I/II pancreatic cancer trial

Phase I of the Glufosfamide/gemcitabine study will evaluate various doses of Glufosfamide in combination with the standard dose of gemcitabine in patients with any kind of advanced solid malignancy for which gemcitabine is currently a treatment option.

The phase I portion of this study may enroll up to 15 patients. The maximum tolerable dose combination determined in phase I of the study will be used in the phase II portion to treat patients with pancreatic cancer. Approximately 47 men and women with advanced pancreatic cancer will be enrolled in the phase II clinical trial at various sites in the US and Latin America.

Earlier in 2004, Threshold announced the initiation of a pivotal phase III clinical trial to evaluate Glufosfamide in patients with metastatic pancreatic cancer refractory to first-line treatment. The data from that trial will be evaluated under a special protocol assessment (SPA) granted by the FDA.

Results from previous phase I and II clinical trials have demonstrated that Glufosfamide shows activity against pancreatic cancer. In an initial phase I trial of Glufosfamide in patients with a variety of solid tumors, the only pancreatic cancer patient enrolled in the trial achieved a complete remission of disease and remained in remission more than five years after receiving Glufosfamide treatment alone.

In a phase II trial of Glufosfamide for the treatment of advanced pancreatic cancer, two of the 34 patients achieved a partial response, and 11 of 34 patients achieved stable disease. Overall two-year survival was estimated at 9%, which compares to 1% or less in historical studies with other first-line therapies.