PharmaEngine presents PEP02 phase II studies in gastric and pancreatic cancers at ASCO 2011

Jan 25 2011

PharmaEngine, Inc. announced today that two phase II studies of PEP02 (liposome irinotecan) in gastric and pancreatic cancer studies were presented at the 2011 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO) in San Francisco, CA, USA.

“There are no global standard second line treatments for either of these patient populations. We believe that PEP02 is worthy of further evaluation in future gastric and pancreatic cancer studies.”

PharmaEngine completed a multi-national (Europe and Asia) randomized non-comparative phase II study of PEP02, irinotecan, or docetaxel as a second line treatment in gastric or gastro-esophageal junction adenocarcinoma. The results of the gastric cancer study were presented orally by the Chief Investigator, Prof. David Cunningham, Royal Marsden Hospital, Sutton, Surrey, UK. 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. On an exploratory basis, a small cohort of patients in the PEP02 arm who did not develop significant toxicity and received escalated dose, had higher tumor response and disease control, as well as longer progression-free survival than either irinotecan or docetaxel.

Data from the ongoing phase II pancreatic cancer study was presented in a poster by Dr. Andrew Ko, University of California, San Francisco, CA, USA. The study is evaluating PEP02 as a second line therapy in 40 metastatic pancreatic cancer patients in Taiwan and the US who were refractory to gemcitabine-containing regimen. 75% of patients achieved the primary endpoint of 3-month survival rate, exceeding the targeted statistical threshold, with acceptable safety. The pancreatic cancer trial is still in progress, with several patients currently remaining enrolled. To date, quite a few patients have survived 6 months or longer.

"I am very encouraged by the positive data of PEP02 in these two international phase II studies in gastric and pancreatic cancers", said Grace Yeh, Ph.D., President and Chief Executive Officer. "There are no global standard second line treatments for either of these patient populations. We believe that PEP02 is worthy of further evaluation in future gastric and pancreatic cancer studies."