NeoPharm has submitted an application to the US Food and Drug Administration (FDA) for a novel delivery system to improve the efficacy of Taxotere, a frontline pancreatic cancer treatment.
The application is for the study of liposome entrapped docetaxel (LE-DT), a novel delivery system for docetaxel, the active ingredient of Taxotere, for locally advanced or metastatic pancreatic cancer patients.
NeoPharm president and CEO Laurence Birch said that the preliminary results from Phase I trials were encouraging.
"As a result, we have submitted a Phase II protocol to the FDA to further evaluate the efficacy of LE-DT in pancreatic cancer patients with locally advanced disease or metastasis," Birch said.
The open-label Phase II study is designed to determine antitumour effect of LE-DT, progression-free survival and overall survival along with specific biologic markers such as CA-19-9 and SPARC expression, which are related to the response of the disease.
If the study is approved, NeoPharm will plan to enrol 40 patients in a Phase II trial at three or four locations in the US and Europe.