THRESHOLD HAS TOP-LINE RESULTS FOR PANCREATIC CANCER TREATMENT
Threshold Pharmaceuticals Dec. 27 announced top-line results from the Phase II clinical trial of glufosfamide in combination with gemcitabine for the treatment of advanced pancreatic cancer. Twenty-one percent of patients in the clinical trial had a partial response (including one unconfirmed partial response) and 36 percent of patients had stable disease. Glufosfamide was generally well tolerated in combination with gemcitabine with no new unexpected adverse events.
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. A partial response is characterized as a decrease in size by 30 percent of the sum of the longest diameters of target lesions, the absence of progression of all non-target lesions and no new lesions. 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.