Pro-Pharmaceuticals' Data Show Davanat/5-FU Well-Tolerated

Pro-Pharmaceuticals has released data indicating Davanat and Davanat/5-FU are well-tolerated in cancer patients with advanced solid tumors.

The data show dose-limiting toxicity and maximum-tolerated dose were not reached when Davanat (280 mg/m2) was administered alone or in combination with 5-FU (500 mg/m2). Of the 40 patients enrolled in the Phase I trial, 28 completed the study (26 had measurable disease and two were nonmeasurable). The disease stabilized in 14 (54 percent) of the 26 patients with measureable disease and 12 (46 percent) had progressive disease. Of the 14 stabilized patients, 10 (71 percent) received additional cycles of Davanat/5-FU. Six of the 10 patients in the sixth and final cohort (highest dose level) were stabilized. Of the 28 patients who completed the study, 18 (64 percent) had colorectal cancer: 10 (55 percent) were stabilized, 7 (39 percent) had disease progression and one was nonmeasurable.

Efficacy results are based on Response Evaluation Criteria in Solid Tumors (RECIST) following completion of the second cycle of treatment. The Phase I data reflects refractory cancer patients with a minimum of 12 weeks to live who had recurrent or metastatic solid tumors that include colorectal, liver, pancreatic, prostate and breast cancers. Three patients had serious adverse events, thought to be at least possibly related to Davanat: dehydration, dyspnea and thrombocytopenia. One unrelated on-study death occurred from unexpectedly rapid disease progression. Adverse events of Davanat/5-FU were similar to those expected for 5-FU alone.