Dec 4 2008
PharmaEngine, Inc. announced today 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.
About PEP02
PEP02 is irinotecan hydrochloride encapsulated in a liposome formulation. Hermes Biosciences, Inc. (South San Francisco, CA, USA) invented the nanoparticle formulation, and licensed it to PharmaEngine to develop, manufacture, and commercialize in Asia and Europe. Irinotecan (CPT-11) is a topoisomerase I inhibitor which has shown significant activity in a variety of tumor types. The Irinotecan Injection (Campto® or Camptosar®) has been approved for the treatment of colorectal cancer with sales of nearly US$1 billion in 2007. However, at high dosage, irinotecan causes severe diarrhea and myelosuppression, which is recognized as the dose-limiting toxicity and limits the use of more aggressive irinotecan therapy.
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.
In early 2008, PharmaEngine initiated a multi-national (Europe and Asia), randomized phase II study of PEP02 as a second line treatment in gastric cancer patients. The study is estimated to complete patient enrollment in the first half of 2009