PharmaEngine announced results from its Phase 2 studies of PEP02 (liposome irinotecan) for the treatment of gastric and pancreatic cancer. The first Phase 2 study evaluated PEP02 as a second line treatment in gastric or gastro-esophageal junction adenocarcinoma. Data from 132 treated patients in 6 countries showed that PEP02 and docetaxel (approved for first line in gastric cancer) met the primary endpoint of tumor response rate, while irinotecan (approved for gastric cancer in Japan and Korea) did not. The disease control rate, progression-free survival, overall survival, and safety data were similar among the three treatment arms in this study. Data from the second, on-going Phase 2, pancreatic cancer trial, demonstrated the following. 75% of patients achieved the primary endpoint of 3-month survival rate, exceeding the targeted statistical threshold, with acceptable safety.

PEP02 is a novel nanoparticle liposome formulation of irinotecan (currently being marketed as Camptosar).

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