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PharmaEngine Receives Approval of US IND Application for a Phase II Study of PEP02 in Pancreatic Cancer
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PharmaEngine, Inc. has announced that it has received approval of an Investigational New Drug (IND) application from the U.S. FDA for PEP02, a liposome formulation of irinotecan in a phase II study in patients with metastatic pancreatic cancer.
Previous phase I data showed excellent pharmacokinetics, tolerability and efficacy of PEP02 in advanced solid tumor patients in a poster presented at 2008 ASCO Annual Meeting.
During the pre-IND meeting this September, the FDA concurred with PharmaEngine’s pancreatic cancer study design, as well as the overall development strategy for pancreatic, gastric, and colorectal cancers. Subsequently, the company completed IND submission in October, and received the safe-to-proceed letter in November.
“I am very delighted that we have achieved an important milestone of IND approval for our second phase II study,” said Grace Yeh, Ph.D., President and Chief Executive Officer. “PharmaEngine is most likely the first Taiwan company which has obtained regulatory approvals for phase II studies in Asia, Europe and the US, based on the phase I data generated in Taiwan.”
The phase II study is an open-label, multi-national, optimal 2-stage design to be conducted in the US and Taiwan. PharmaEngine plans to enroll metastatic pancreatic cancer patients who failed gemcitabine containing regimen during 2009. There is no standard second line treatment for this nearly fatal cancer.
