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Published on 5/30/2006 in the Prospect News Biotech Daily.

NeoPharm begins enrollment of up to 54 patients in phase 2 trial of LE-SN38 for colorectal cancer

By Lisa Kerner

Erie, Pa., May 30 - NeoPharm, Inc. said patient enrollment has started in a multi-center phase 2 clinical trial of LE-SN38, the NeoLipid liposomal formulation of SN-38, an active metabolite of irinotecan (Camptosar), in the treatment of patients with metastatic colorectal cancer. Enrollment is expected to take up to one year.

The trial is being conducted by Cancer and Leukemia Group B, an oncology clinical research group sponsored by the National Cancer Institute, according to a company news release.

Up to 54 patients will receive LE-SN38 by intravenous infusion over 90 minutes every 21 days as long as the tumor does not grow or treatment can no longer be tolerated by the patient.

NeoPharm said the primary endpoint is overall tumor response rate, with additional endpoints being safety profile, progression-free survival and overall survival.

Colorectal cancer is the third most common cancer and the third leading cause of cancer-related mortality in the United States, according to the National Cancer Institute.

NeoPharm is a biopharmaceutical company based in Waukegan, Ill.


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