Threshold Pharmaceuticals Inc. has announced top-line results from the phase II clinical trial of glufosfamide in combination with gemcitabine for the treatment of advanced pancreatic cancer. 21 per cent of patients in the clinical trial had a partial response (including one unconfirmed partial response) and 36 per cent of patients had stable disease. Glufosfamide was generally well tolerated in combination with gemcitabine with no new unexpected adverse events.

"We are pleased with these encouraging top-line results and look forward next year to additional six-and twelve-month survival data from this clinical trial," said Barry Selick, PhD, Threshold's chief executive officer. "We remain focused on our goal of bringing another treatment option to patients with pancreatic cancer."

In the Phase II clinical trial, 29 patients were treated, of which 28 patients with pancreatic adenocarcinoma previously untreated with chemotherapy were evaluated for response. Overall, 5 patients achieved a confirmed partial response and one other patient achieved an unconfirmed partial response. In addition, 10 patients experienced stable disease. Objective response was assessed radiologically after every two cycles of therapy.

30 per cent of the sum of the longest diameters of target lesions, the absence of progression of all non-target lesions and no new lesions characterize a partial response as a decrease in size.

Preliminary analysis of the safety data in this phase II glufosfamide and gemcitabine combination trial suggests the incidence of treatment-related nephrotoxicity may be slightly higher than what was observed in previous experience with either of these agents used individually.

This clinical trial remains ongoing. Final survival and safety results will be reported at the completion of the trial, estimated to occur by the end of the third quarter of 2007.

The phase II clinical trial is evaluating patients with locally advanced and/or metastatic pancreatic adenocarcinoma previously untreated with chemotherapy. Patients receive the standard dose of gemcitabine plus glufosfamide. In addition to safety, the trial is investigating the efficacy of glufosfamide in combination with gemcitabine as determined by response rate, duration of response, progression-free survival, overall survival, six- and twelve-month survival and change in serum tumour marker levels (CA19-9).