NeoPharm Inc has received permission from the U.S. Food and Drug Administration (FDA) to proceed with planned Phase I clinical trials for LEP-ETU, the Company's unique and proprietary NeoLipid liposomal formulation of the cancer fighting compound paclitaxel. The Phase I clinical trial is planned to begin by August 2003 and will be conducted at three leading cancer research centers. The H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida in Tampa, Florida, a member of the National Comprehensive Cancer Network (NCCN), will be the lead investigational site for this Phase I study designed to determine the maximum tolerated dose (MTD) of LEP-ETU in patients with advanced cancer.
"We are moving quickly to advance LEP-ETU into clinical trials," said James M. Hussey, NeoPharm's President and CEO. "The LEP-ETU development program is a testament to the flexibility of our NeoLipid technology and the skill and dedication of our research and development team. We were able to submit the LEP-ETU IND about a year after we started this project and cleared the FDA review thirty days later."
A "late-breaking" research abstract has been accepted for a poster presentation at the recently rescheduled 2003 AACR 94th Annual Meeting in Washington, DC to be held from July 11-14, 2003. The research abstract and poster presentation describe the results from recently completed pre-clinical studies of LEP-ETU, in which the anticancer effects of LEP-ETU were tested against several mice tumor models.