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news.PharmaEngine, a biopharmaceutical company, has received approval of an investigational new drug application from the FDA for PEP02, a liposome formulation of irinotecan in a Phase II study in patients with metastatic pancreatic cancer.
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The Phase II study is an open-label, multi-national, optimal two-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.
In the Phase I clinical studies in advanced solid tumor patients, PEP02 given as a single agent or in combination with other chemotherapeutic agents showed a better pharmacokinetic, safety and efficacy profile, which compared favorably to the published data of unencapsulated irinotecan, or other types of formulations, the company said.
Grace Yeh, president and CEO of PharmaEngine, said: “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.”