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Purpose
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LE-SN38 is NeoPharm's NeoLipid liposomal formulation of SN-38, the active metabolite of irinotecan (Camptosar), a chemotherapeutic pro-drug approved for the treatment of advanced colorectal cancer. LE-SN38 is the Company's NeoLipid® Liposomal formulation of SN-38, the active, but poorly soluble, metabolite of Camptosar®, a chemotherapeutic pro-drug, which is used as a first-line and second-line treatment for advanced colorectal cancer. A pro-drug is a compound that is converted into the active drug in the body. However, Camptosar® is converted into SN-38 in colorectal cancer cells at different rates in different patients, and this variability in conversion rates may result in suboptimal treatment. By employing the Company's proprietary NeoLipid® technology to directly deliver SN-38, the Company hopes to minimize treatment variability. A Phase I clinical trial was completed in 2005 and showed the potential for decreased side effects, particularly diarrhea, compared to published results of Camptosar®. The results of that trial were presented at the American Society of Clinical Oncology (ASCO) meeting in June 2005, and were used to determine the Phase II study dose. .
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